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21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
300
|
GENERAL
|
Subpart B
|
Combination Drugs
|
300.50
|
Fixed-combination prescription drugs for humans.
|
The Food and Drug Administration's policy in administering the new-drug, antibiotic, and other regulatory provisions of the Federal Food, Drug, and Cosmetic Act regarding fixed combination dosage form prescription drugs for humans is as follows:
(a) Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug. Special cases of this general rule are where a component is added:
(1) To enhance the safety or effectiveness of the principal active component; and
(2) To minimize the potential for abuse of the principal active component.
(b) If a combination drug presently the subject of an approved new-drug application or antibiotic monograph has not been recognized as effective by the Commissioner of Food and Drugs based on his evaluation of the appropriate National Academy of Sciences-National Research Council panel report, or if substantial evidence of effectiveness has not otherwise been presented for it, then formulation, labeling, or dosage changes may be proposed and any resulting formulation may meet the appropriate criteria listed in paragraph (a) of this section.
(c) A fixed-combination prescription drug for humans that has been determined to be effective for labeled indications by the Food and Drug Administration, based on evaluation of the NAS-NRC report on the combination, is considered to be in compliance with the requirements of this section.
|
regulation
|
[{"label": "(a)", "text": "Two or more drugs may be combined in a single dosage form when each component makes a contribution to the claimed effects and the dosage of each component (amount, frequency, duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy as defined in the labeling for the drug. Special cases of this general rule are where a component is added:", "source": null}, {"label": "(1)", "text": "To enhance the safety or effectiveness of the principal active component; and", "source": null}, {"label": "(2)", "text": "To minimize the potential for abuse of the principal active component.", "source": null}, {"label": "(b)", "text": "If a combination drug presently the subject of an approved new-drug application or antibiotic monograph has not been recognized as effective by the Commissioner of Food and Drugs based on his evaluation of the appropriate National Academy of Sciences-National Research Council panel report, or if substantial evidence of effectiveness has not otherwise been presented for it, then formulation, labeling, or dosage changes may be proposed and any resulting formulation may meet the appropriate criteria listed in paragraph (a) of this section.", "source": null}, {"label": "(c)", "text": "A fixed-combination prescription drug for humans that has been determined to be effective for labeled indications by the Food and Drug Administration, based on evaluation of the NAS-NRC report on the combination, is considered to be in compliance with the requirements of this section.", "source": null}]
|
[40 FR 13496, Mar. 27, 1975]
|
Mar. 27, 1975
|
(Revised as of April 1, 1996)
|
False
|
False
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:300:300.50
|
|||||||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
300
|
GENERAL
|
Subpart C
|
Substances Generally Prohibited From Drugs
|
300.100
|
Chlorofluorocarbon propellants.
|
The use of chlorofluorocarbons in human drugs as propellants in self-pressurized containers is generally prohibited except as provided by § 2.125 of this chapter.
|
regulation
|
§ 2.125
|
[43 FR 11317, Mar. 17, 1978]
|
Mar. 17, 1978
|
(Revised as of April 1, 1996)
|
False
|
False
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:300:300.100
|
|||||||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
Pt. 310
|
NEW DRUGS
|
Subpart A
|
General Provisions
|
310.3
|
Definitions and interpretations.
|
As used in this part:
(a) The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).
(b) Department means the Department of Health and Human Services.
(c) Secretary means the Secretary of Health and Human Services.
(d) Commissioner means the Commissioner of Food and Drugs.
(e) The term person includes individuals, partnerships, corporations, and associations.
(f) The definitions and interpretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part.
(g) New drug substance means any substance that when used in the manufacture, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substance.
(h) The newness of a drug may arise by reason (among other reasons) of:
(1) The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component.
(2) The newness for a drug use of a combination of two or more substances, none of which is a new drug.
(3) The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new drug.
(4) The newness of use of such drug in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect another structure or function of the body.
(5) The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug.
(i) [Reserved]
(j) The term sponsor means the person or agency who assumes responsibility for an investigation of a new drug, including responsibility for compliance with applicable provisions of the act and regulations. The “sponsor” may be an individual, partnership, corporation, or Government agency and may be a manufacturer, scientific institution, or an investigator regularly and lawfully engaged in the investigation of new drugs.
(k) The phrase related drug(s) includes other brands, potencies, dosage forms, salts, and esters of the same drug moiety, including articles prepared or manufactured by other manufacturers: and any other drug containing a component so related by chemical structure or known pharmacological properties that, in the opinion of experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, it is prudent to assume or ascertain the liability of similar side effects and contraindications.
(l) Special packaging as defined in section 2(4) of the Poison Prevention Packaging Act of 1970 means packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.
(m) [Reserved]
(n) The term radioactive drug means any substance defined as a drug in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term “radioactive drug” includes a “radioactive biological product” as defined in § 600.3(ee) of this chapter.
|
regulation
|
[{"label": "(a)", "text": "The term act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-902, 52 Stat. 1040 et seq., as amended; 21 U.S.C. 321-392).", "source": null}, {"label": "(b)", "text": "Department means the Department of Health and Human Services.", "source": null}, {"label": "(c)", "text": "Secretary means the Secretary of Health and Human Services.", "source": null}, {"label": "(d)", "text": "Commissioner means the Commissioner of Food and Drugs.", "source": null}, {"label": "(e)", "text": "The term person includes individuals, partnerships, corporations, and associations.", "source": null}, {"label": "(f)", "text": "The definitions and interpretations of terms contained in section 201 of the act shall be applicable to such terms when used in the regulations in this part.", "source": null}, {"label": "(g)", "text": "New drug substance means any substance that when used in the manufacture, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substance.", "source": null}, {"label": "(h)", "text": "The newness of a drug may arise by reason (among other reasons) of:", "source": null}, {"label": "(1)", "text": "The newness for drug use of any substance which composes such drug, in whole or in part, whether it be an active substance or a menstruum, excipient, carrier, coating, or other component.", "source": null}, {"label": "(2)", "text": "The newness for a drug use of a combination of two or more substances, none of which is a new drug.", "source": null}, {"label": "(3)", "text": "The newness for drug use of the proportion of a substance in a combination, even though such combination containing such substance in other proportion is not a new drug.", "source": null}, {"label": "(4)", "text": "The newness of use of such drug in diagnosing, curing, mitigating, treating, or preventing a disease, or to affect a structure or function of the body, even though such drug is not a new drug when used in another disease or to affect another structure or function of the body.", "source": null}, {"label": "(5)", "text": "The newness of a dosage, or method or duration of administration or application, or other condition of use prescribed, recommended, or suggested in the labeling of such drug, even though such drug when used in other dosage, or other method or duration of administration or application, or different condition, is not a new drug.", "source": null}, {"label": "(i)", "text": "[Reserved]", "source": null}, {"label": "(j)", "text": "The term sponsor means the person or agency who assumes responsibility for an investigation of a new drug, including responsibility for compliance with applicable provisions of the act and regulations. The “sponsor” may be an individual, partnership, corporation, or Government agency and may be a manufacturer, scientific institution, or an investigator regularly and lawfully engaged in the investigation of new drugs.", "source": null}, {"label": "(k)", "text": "The phrase related drug(s) includes other brands, potencies, dosage forms, salts, and esters of the same drug moiety, including articles prepared or manufactured by other manufacturers: and any other drug containing a component so related by chemical structure or known pharmacological properties that, in the opinion of experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, it is prudent to assume or ascertain the liability of similar side effects and contraindications.", "source": null}, {"label": "(l)", "text": "Special packaging as defined in section 2(4) of the Poison Prevention Packaging Act of 1970 means packaging that is designed or constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly, but does not mean packaging which all such children cannot open or obtain a toxic or harmful amount within a reasonable time.", "source": null}, {"label": "(m)", "text": "[Reserved]", "source": null}, {"label": "(n)", "text": "The term radioactive drug means any substance defined as a drug in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides. The term “radioactive drug” includes a “radioactive biological product” as defined in § 600.3(ee) of this chapter.", "source": null}]
|
21 U.S.C. 321
|
§ 600.3
|
[39 FR 11680, Mar. 29, 1974, as amended at 39 FR 20484, June 11, 1974; 40 FR 31307, July 25, 1975; 46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985]
|
Mar. 29, 1974
|
(Revised as of April 1, 1996)
|
False
|
True
|
The term act; The term radioactive drug; The term sponsor; New drug substance
|
5 years
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:Pt._310:310.3
|
|||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
Pt. 310
|
NEW DRUGS
|
Subpart A
|
General Provisions
|
310.4
|
Biologics; products subject to license control.
|
(a) Except for radioactive biological products intended for human use, a new drug shall not be deemed to be subject to section 505 of the act if it is a drug licensed under the Public Health Service Act of July 1, 1944 (58 Stat. 682, as amended (42 U.S.C. 201 et seq.)) or under the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832 (21 U.S.C. 151 et seq.)).
(b) A radioactive biological product (as defined in § 600.3(ee) of this chapter) intended for human use is subject to section 505 of the act. Any license for such a radioactive biological product which is issued under the Public Health Service Act of July 1, 1944 (58 Stat. 682, as amended (42 U.S.C. 201 et seq.)) and which has not been revoked or suspended as of August 25, 1975 shall constitute an approved new drug application in effect under the same terms and conditions as set forth in such license and such portions of the establishment license relating to such product, which include data and information required under part 314 of this chapter for a new drug application. Any such radioactive biological product for which licensure under the Public Health Service Act is pending on August 25, 1975 shall, upon determination that it is acceptable for licensure, be approved as a new drug application in lieu of issuance of a biological product license.
|
regulation
|
[{"label": "(a)", "text": "Except for radioactive biological products intended for human use, a new drug shall not be deemed to be subject to section 505 of the act if it is a drug licensed under the Public Health Service Act of July 1, 1944 (58 Stat. 682, as amended (42 U.S.C. 201 et seq.)) or under the animal virus, serum, and toxin law of March 4, 1913 (37 Stat. 832 (21 U.S.C. 151 et seq.)).", "source": null}, {"label": "(b)", "text": "A radioactive biological product (as defined in § 600.3(ee) of this chapter) intended for human use is subject to section 505 of the act. Any license for such a radioactive biological product which is issued under the Public Health Service Act of July 1, 1944 (58 Stat. 682, as amended (42 U.S.C. 201 et seq.)) and which has not been revoked or suspended as of August 25, 1975 shall constitute an approved new drug application in effect under the same terms and conditions as set forth in such license and such portions of the establishment license relating to such product, which include data and information required under part 314 of this chapter for a new drug application. Any such radioactive biological product for which licensure under the Public Health Service Act is pending on August 25, 1975 shall, upon determination that it is acceptable for licensure, be approved as a new drug application in lieu of issuance of a biological product license.", "source": null}]
|
42 U.S.C. 201; 21 U.S.C. 151
|
§ 600.3
|
[40 FR 31312, July 25, 1975]
|
July 25, 1975
|
(Revised as of April 1, 1996)
|
False
|
False
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:Pt._310:310.4
|
|||||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
Pt. 310
|
NEW DRUGS
|
Subpart A
|
General Provisions
|
310.6
|
Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products.
|
(a) The Food and Drug Administration's conclusions on the effectiveness of drugs are currently being published in the Federal Register as Drug Efficacy Study Implementation (DESI) Notices and as Notices of Opportunity for Hearing. The specific products listed in these notices include only those that were introduced into the market through the new drug procedures from 1938-62 and were submitted for review by the National Academy of Sciences-National Research Council (NAS-NRC), Drug Efficacy Study Group. Many products which are identical to, related to, or similar to the products listed in these notices have been marketed under different names or by different firms during this same period or since 1962 without going through the new drug procedures or the Academy review. Even though these products are not listed in the notices, they are covered by the new drug applications reviewed and thus are subject to these notices. All persons with an interest in a product that is identical, related, or similar to a drug listed in a drug efficacy notice or a notice of opportunity for a hearing will be given the same opportunity as the applicant to submit data and information, to request a hearing, and to participate in any hearing. It is not feasible for the Food and Drug Administration to list all products which are covered by an NDA and thus subject to each notice. However, it is essential that the findings and conclusions that a drug product is a “new drug” or that there is a lack of evidence to show that a drug product is safe or effective be applied to all identical, related, and similar drug products to which they are reasonably applicable. Any product not in compliance with an applicable drug efficacy notice is in violation of section 505 (new drugs) and/or section 502 (misbranding) of the act.
(b)(1) An identical, related, or similar drug includes other brands, potencies, dosage forms, salts, and esters of the same drug moiety as well as of any drug moiety related in chemical structure or known pharmacological properties.
(2) Where experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs would conclude that the findings and conclusions, stated in a drug efficacy notice or notice of opportunity for hearing, that a drug product is a “new drug” or that there is a lack of evidence to show that a drug product is safe or effective are applicable to an identical, related, or similar drug product, such product is affected by the notice. A combination drug product containing a drug that is identical, related, or similar to a drug named in a notice may also be subject to the findings and conclusions in a notice that a drug product is a “new drug” or that there is a lack of evidence to show that a drug product is safe or effective.
(3) Any person may request an opinion on the applicability of such a notice to a specific product by writing to the Food and Drug Administration at the address shown in paragraph (e) of this section.
(c) Manufacturers and distributors of drugs should review their products as drug efficacy notices are published and assure that identical, related, or similar products comply with all applicable provisions of the notices.
(d) The published notices and summary lists of the conclusions are of particular interest to drug purchasing agents. These agents should take particular care to assure that the same purchasing policy applies to drug products that are identical, related, or similar to those named in the drug efficacy notices. The Food and Drug Administration applies the same regulatory policy to all such products. In many instances a determination can readily be made as to the applicability of a drug efficacy notice by an individual who is knowledgeable about drugs and their indications for use. Where the relationships are more subtle and not readily recognized, the purchasing agent may request an opinion by writing to the Food and Drug Administration at the address shown in paragraph (e) of this section.
(e) Interested parties may submit to the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, HFD-300, 5600 Fishers Lane, Rockville, MD 20857, the names of drug products, and of their manufacturers or distributors, that should be the subject of the same purchasing and regulatory policies as those reviewed by the Drug Efficacy Study Group. Appropriate action, including referral to purchasing officials of various government agencies, will be taken.
(f) This regulation does not apply to OTC drugs identical, similar, or related to a drug in the Drug Efficacy Study unless there has been or is notification in the Federal Register that a drug will not be subject to an OTC panel review pursuant to §§ 330.10, 330.11, and 330.5 of this chapter.
|
regulation
|
[{"label": "(a)", "text": "The Food and Drug Administration's conclusions on the effectiveness of drugs are currently being published in the Federal Register as Drug Efficacy Study Implementation (DESI) Notices and as Notices of Opportunity for Hearing. The specific products listed in these notices include only those that were introduced into the market through the new drug procedures from 1938-62 and were submitted for review by the National Academy of Sciences-National Research Council (NAS-NRC), Drug Efficacy Study Group. Many products which are identical to, related to, or similar to the products listed in these notices have been marketed under different names or by different firms during this same period or since 1962 without going through the new drug procedures or the Academy review. Even though these products are not listed in the notices, they are covered by the new drug applications reviewed and thus are subject to these notices. All persons with an interest in a product that is identical, related, or ", "source": null}, {"label": "(2)", "text": "Where experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs would conclude that the findings and conclusions, stated in a drug efficacy notice or notice of opportunity for hearing, that a drug product is a “new drug” or that there is a lack of evidence to show that a drug product is safe or effective are applicable to an identical, related, or similar drug product, such product is affected by the notice. A combination drug product containing a drug that is identical, related, or similar to a drug named in a notice may also be subject to the findings and conclusions in a notice that a drug product is a “new drug” or that there is a lack of evidence to show that a drug product is safe or effective.", "source": null}, {"label": "(3)", "text": "Any person may request an opinion on the applicability of such a notice to a specific product by writing to the Food and Drug Administration at the address shown in paragraph (e) of this section.", "source": null}, {"label": "(c)", "text": "Manufacturers and distributors of drugs should review their products as drug efficacy notices are published and assure that identical, related, or similar products comply with all applicable provisions of the notices.", "source": null}, {"label": "(d)", "text": "The published notices and summary lists of the conclusions are of particular interest to drug purchasing agents. These agents should take particular care to assure that the same purchasing policy applies to drug products that are identical, related, or similar to those named in the drug efficacy notices. The Food and Drug Administration applies the same regulatory policy to all such products. In many instances a determination can readily be made as to the applicability of a drug efficacy notice by an individual who is knowledgeable about drugs and their indications for use. Where the relationships are more subtle and not readily recognized, the purchasing agent may request an opinion by writing to the Food and Drug Administration at the address shown in paragraph (e) of this section.", "source": null}, {"label": "(e)", "text": "Interested parties may submit to the Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, HFD-300, 5600 Fishers Lane, Rockville, MD 20857, the names of drug products, and of their manufacturers or distributors, that should be the subject of the same purchasing and regulatory policies as those reviewed by the Drug Efficacy Study Group. Appropriate action, including referral to purchasing officials of various government agencies, will be taken.", "source": null}, {"label": "(f)", "text": "This regulation does not apply to OTC drugs identical, similar, or related to a drug in the Drug Efficacy Study unless there has been or is notification in the Federal Register that a drug will not be subject to an OTC panel review pursuant to §§ 330.10, 330.11, and 330.5 of this chapter.", "source": null}]
|
§ 330.10
|
[39 FR 11680, Mar. 29, 1974, as amended at 48 FR 2755, Jan. 21, 1983; 50 FR 8996, Mar. 6, 1985; 55 FR 11578, Mar. 29, 1990]
|
Mar. 29, 1974
|
(Revised as of April 1, 1996)
|
False
|
False
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:Pt._310:310.6
|
||||||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
Pt. 310
|
NEW DRUGS
|
Subpart B
|
Specific Administrative Rulings and Decisions
|
310.100
|
New drug status opinions; statement of policy.
|
(a) Over the years since 1938 the Food and Drug Administration has given informal advice to inquirers as to the new drug status of preparations. These drugs have sometimes been identified only by general statements of composition. Generally, such informal opinions were incorporated in letters that did not explicitly relate all of the necessary conditions and qualifications such as the quantitative formula for the drug and the conditions under which it was prescribed, recommended, or suggested. This has contributed to misunderstanding and misinterpretation of such opinions.
(b) These informal opinions that an article is “not a new drug” or “no longer a new drug” require reexamination under the Kefauver-Harris Act (Public Law 87-781; 76 Stat. 788-89). In particular, when approval of a new drug application is withdrawn under provisions of section 505(e) of the Federal Food, Drug, and Cosmetic Act, a drug generally recognized as safe may become a “new drug” within the meaning of section 201(p) of said act as amended by the Kefauver-Harris Act on October 10, 1962. This is of special importance by reason of proposed actions to withdraw approval of new drug applications for lack of substantial evidence of effectiveness as a result of reports of the National Academy of Sciences—National Research Council on its review of drug effectiveness; for example, see the notice published in the Federal Register of January 23, 1968 (33 FR 818), regarding rutin, quercetin, et al.
(c) Any marketed drug is a “new drug” if any labeling change made after October 9, 1962, recommends or suggests new conditions of use under which the drug is not generally recognized as safe and effective by qualified experts. Undisclosed or unreported side effects as well as the emergence of new knowledge presenting questions with respect to the safety or effectiveness of a drug may result in its becoming a “new drug” even though it was previously considered “not a new drug.” Any previously given informal advice that an article is “not a new drug” does not apply to such an article if it has been changed in formulation, manufacture control, or labeling in a way that may significantly affect the safety of the drug.
(d) For these reasons, all opinions previously given by the Food and Drug Administration to the effect that an article is “not a new drug” or is “no longer a new drug” are hereby revoked. This does not mean that all articles that were the subjects of such prior opinions will be regarded as new drugs. The prior opinions will be replaced by opinions of the Food and Drug Administration that are qualified and current on when an article is “not a new drug,” as set forth in this subchapter.
|
regulation
|
[{"label": "(a)", "text": "Over the years since 1938 the Food and Drug Administration has given informal advice to inquirers as to the new drug status of preparations. These drugs have sometimes been identified only by general statements of composition. Generally, such informal opinions were incorporated in letters that did not explicitly relate all of the necessary conditions and qualifications such as the quantitative formula for the drug and the conditions under which it was prescribed, recommended, or suggested. This has contributed to misunderstanding and misinterpretation of such opinions.", "source": null}, {"label": "(b)", "text": "These informal opinions that an article is “not a new drug” or “no longer a new drug” require reexamination under the Kefauver-Harris Act (Public Law 87-781; 76 Stat. 788-89). In particular, when approval of a new drug application is withdrawn under provisions of section 505(e) of the Federal Food, Drug, and Cosmetic Act, a drug generally recognized as safe may become a “new drug” within the meaning of section 201(p) of said act as amended by the Kefauver-Harris Act on October 10, 1962. This is of special importance by reason of proposed actions to withdraw approval of new drug applications for lack of substantial evidence of effectiveness as a result of reports of the National Academy of Sciences—National Research Council on its review of drug effectiveness; for example, see the notice published in the Federal Register of January 23, 1968 (33 FR 818), regarding rutin, quercetin, et al.", "source": null}, {"label": "(c)", "text": "Any marketed drug is a “new drug” if any labeling change made after October 9, 1962, recommends or suggests new conditions of use under which the drug is not generally recognized as safe and effective by qualified experts. Undisclosed or unreported side effects as well as the emergence of new knowledge presenting questions with respect to the safety or effectiveness of a drug may result in its becoming a “new drug” even though it was previously considered “not a new drug.” Any previously given informal advice that an article is “not a new drug” does not apply to such an article if it has been changed in formulation, manufacture control, or labeling in a way that may significantly affect the safety of the drug.", "source": null}, {"label": "(d)", "text": "For these reasons, all opinions previously given by the Food and Drug Administration to the effect that an article is “not a new drug” or is “no longer a new drug” are hereby revoked. This does not mean that all articles that were the subjects of such prior opinions will be regarded as new drugs. The prior opinions will be replaced by opinions of the Food and Drug Administration that are qualified and current on when an article is “not a new drug,” as set forth in this subchapter.", "source": null}]
|
Pub. L. 87-781
|
[39 FR 11680, Mar. 29, 1974]
|
Mar. 29, 1974
|
(Revised as of April 1, 1996)
|
False
|
False
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:Pt._310:310.100
|
||||||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
Pt. 310
|
NEW DRUGS
|
Subpart B
|
Specific Administrative Rulings and Decisions
|
310.101
|
FD&C Red No. 4; procedure for discontinuing use in new drugs for ingestion; statement of policy.
|
(a) Section 81.10(d) of this chapter published December 11, 1964 (29 FR 16983), terminated the provisional listing of FD&C Red No. 4 for use in drugs that may be ingested and canceled the effectiveness of certificates for this color additive and mixtures containing it as of June 9, 1965 (§ 81.30(c) of this chapter), insofar as ingested drugs are concerned. On August 19, 1965 (30 FR 10289), FD&C Red No. 4 was restored to provisional listing by amendment to § 81.1(a) of this chapter, which restricted the use of color to the terms of § 81.25 of this chapter. The use of FD&C Red No. 4 or mixtures containing it in the manufacture of ingested drugs (except for limited use as provided in § 81.25 of this chapter) will result in adulteration and may constitute grounds for withdrawing approval of drugs for which a new drug approval is in effect.
(b) An approved supplemental new drug application will not be required to provide for discontinuing the use of FD&C Red No. 4 in the manufacture of articles that are the subject of approved new drug applications, provided that the applicant submits to the Food and Drug Administration a written notice of the date on which the change in formulation will be put into effect.
(c) It will be the policy of the Food and Drug Administration to take no action against a drug or applicant where a permitted color additive is substituted for FD&C Red No. 4 in the manufacture of a drug prior to receipt of a written notice of approval of a supplemental new drug application, provided that the applicant submits a satisfactory supplemental application meeting all the following conditions:
(1) The applicant submits a full list of the components and a full statement of the composition of the drug.
(2) The date when the composition of the drug will be changed is stated.
(3) The applicant submits data showing that the change in composition does not interfere with any assay or other control procedures used in manufacturing the drug, or that the assay and other control procedures are revised to make them adequate.
(4) The data available to establish the stability of the revised formulation are included, and if the data are too limited to support a conclusion that the drug will retain its declared potency for a reasonable marketing period, a commitment from the applicant:
(i) To test the stability of marketed batches at reasonable intervals;
(ii) To submit the data as they become available; and
(iii) To recall from the market any batch found to fall below the approved specifications for the drug.
(d) When a supplemental application proposes the change prescribed in paragraph (c) of this section and the applicant informs the Food and Drug Administration that the changes have been put into effect, such notification will be regarded as an agreement by the applicant to an extension of the time for formal action on the supplemental application.
(e) Except as provided in paragraph (c) of this section, no provision of this statement of policy shall limit the authority of the Secretary of Health and Human Services or of the Commissioner of Food and Drugs to suspend or withdraw approval of a new-drug application as prescribed by section 505(e) of the act or to initiate any other regulatory proceedings with respect to a drug or applicant under the provisions of the act.
|
regulation
|
[{"label": "(a)", "text": "Section 81.10(d) of this chapter published December 11, 1964 (29 FR 16983), terminated the provisional listing of FD&C Red No. 4 for use in drugs that may be ingested and canceled the effectiveness of certificates for this color additive and mixtures containing it as of June 9, 1965 (§ 81.30(c) of this chapter), insofar as ingested drugs are concerned. On August 19, 1965 (30 FR 10289), FD&C Red No. 4 was restored to provisional listing by amendment to § 81.1(a) of this chapter, which restricted the use of color to the terms of § 81.25 of this chapter. The use of FD&C Red No. 4 or mixtures containing it in the manufacture of ingested drugs (except for limited use as provided in § 81.25 of this chapter) will result in adulteration and may constitute grounds for withdrawing approval of drugs for which a new drug approval is in effect.", "source": null}, {"label": "(b)", "text": "An approved supplemental new drug application will not be required to provide for discontinuing the use of FD&C Red No. 4 in the manufacture of articles that are the subject of approved new drug applications, provided that the applicant submits to the Food and Drug Administration a written notice of the date on which the change in formulation will be put into effect.", "source": null}, {"label": "(c)", "text": "It will be the policy of the Food and Drug Administration to take no action against a drug or applicant where a permitted color additive is substituted for FD&C Red No. 4 in the manufacture of a drug prior to receipt of a written notice of approval of a supplemental new drug application, provided that the applicant submits a satisfactory supplemental application meeting all the following conditions:", "source": null}, {"label": "(1)", "text": "The applicant submits a full list of the components and a full statement of the composition of the drug.", "source": null}, {"label": "(2)", "text": "The date when the composition of the drug will be changed is stated.", "source": null}, {"label": "(3)", "text": "The applicant submits data showing that the change in composition does not interfere with any assay or other control procedures used in manufacturing the drug, or that the assay and other control procedures are revised to make them adequate.", "source": null}, {"label": "(4)", "text": "The data available to establish the stability of the revised formulation are included, and if the data are too limited to support a conclusion that the drug will retain its declared potency for a reasonable marketing period, a commitment from the applicant:", "source": null}, {"label": "(i)", "text": "To test the stability of marketed batches at reasonable intervals;", "source": null}, {"label": "(ii)", "text": "To submit the data as they become available; and", "source": null}, {"label": "(iii)", "text": "To recall from the market any batch found to fall below the approved specifications for the drug.", "source": null}, {"label": "(d)", "text": "When a supplemental application proposes the change prescribed in paragraph (c) of this section and the applicant informs the Food and Drug Administration that the changes have been put into effect, such notification will be regarded as an agreement by the applicant to an extension of the time for formal action on the supplemental application.", "source": null}, {"label": "(e)", "text": "Except as provided in paragraph (c) of this section, no provision of this statement of policy shall limit the authority of the Secretary of Health and Human Services or of the Commissioner of Food and Drugs to suspend or withdraw approval of a new-drug application as prescribed by section 505(e) of the act or to initiate any other regulatory proceedings with respect to a drug or applicant under the provisions of the act.", "source": null}]
|
§ 81.30; § 81.25; § 81.1
|
[39 FR 11680, Mar. 29, 1974, as amended at 42 FR 15674, Mar. 22, 1977]
|
Mar. 29, 1974
|
(Revised as of April 1, 1996)
|
False
|
False
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:Pt._310:310.101
|
||||||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
Pt. 310
|
NEW DRUGS
|
Subpart B
|
Specific Administrative Rulings and Decisions
|
310.103
|
New drug substances intended for hypersensitivity testing.
|
(a) The Food and Drug Administration is aware of the need in the practice of medicine for the ingredients of a new drug to be available for tests of hypersensitivity to such ingredients and therefore will not object to the shipment of a new drug substance, as defined in § 310.3(g), for such purpose if all of the following conditions are met:
(1) The shipment is made as a result of a specific request made to the manufacturer or distributor by a practitioner licensed by law to administer such drugs, and the use of such drugs for patch testing is not promoted by the manufacturer or distributor.
(2) The new drug substance requested is an ingredient in a marketed new drug and is not one that is an ingredient solely in a new drug that is legally available only under the investigational drug provisions of this part.
(3) The label bears the following prominently placed statements in lieu of adequate directions for use and in addition to complying with the other labeling provisions of the act:
(i) “Caution: Federal law prohibits dispensing without a prescription”; and
(ii) “For use only in patch testing”.
(4) The quantity shipped is limited to an amount reasonable for the purpose of patch testing in the normal course of the practice of medicine and is used solely for such patch testing.
(5) The new drug substance is manufactured by the same procedures and meets the same specifications as the component used in the finished dosage form.
(6) The manufacturer or distributor maintains records of all shipments for this purpose for a period of 2 years after shipment and will make them available to the Food and Drug Administration on request.
(b) When the requested new drug substance is intended for investigational use in humans or the substance is legally available only under the investigational drug provisions of part 312 of this chapter, the submission of an “Investigational New Drug Application” (IND) is required. The Food and Drug Administration will offer assistance to any practitioner wishing to submit an Investigational New Drug Application.
(c) This section does not apply to drugs or their components that are subject to the licensing requirements of the Public Health Service Act of 1944, as amended. (See subchapter F—Biologics, of this chapter.)
|
regulation
|
[{"label": "(a)", "text": "The Food and Drug Administration is aware of the need in the practice of medicine for the ingredients of a new drug to be available for tests of hypersensitivity to such ingredients and therefore will not object to the shipment of a new drug substance, as defined in § 310.3(g), for such purpose if all of the following conditions are met:", "source": null}, {"label": "(1)", "text": "The shipment is made as a result of a specific request made to the manufacturer or distributor by a practitioner licensed by law to administer such drugs, and the use of such drugs for patch testing is not promoted by the manufacturer or distributor.", "source": null}, {"label": "(2)", "text": "The new drug substance requested is an ingredient in a marketed new drug and is not one that is an ingredient solely in a new drug that is legally available only under the investigational drug provisions of this part.", "source": null}, {"label": "(3)", "text": "The label bears the following prominently placed statements in lieu of adequate directions for use and in addition to complying with the other labeling provisions of the act:", "source": null}, {"label": "(i)", "text": "“Caution: Federal law prohibits dispensing without a prescription”; and", "source": null}, {"label": "(ii)", "text": "“For use only in patch testing”.", "source": null}, {"label": "(4)", "text": "The quantity shipped is limited to an amount reasonable for the purpose of patch testing in the normal course of the practice of medicine and is used solely for such patch testing.", "source": null}, {"label": "(5)", "text": "The new drug substance is manufactured by the same procedures and meets the same specifications as the component used in the finished dosage form.", "source": null}, {"label": "(6)", "text": "The manufacturer or distributor maintains records of all shipments for this purpose for a period of 2 years after shipment and will make them available to the Food and Drug Administration on request.", "source": null}, {"label": "(b)", "text": "When the requested new drug substance is intended for investigational use in humans or the substance is legally available only under the investigational drug provisions of part 312 of this chapter, the submission of an “Investigational New Drug Application” (IND) is required. The Food and Drug Administration will offer assistance to any practitioner wishing to submit an Investigational New Drug Application.", "source": null}, {"label": "(c)", "text": "This section does not apply to drugs or their components that are subject to the licensing requirements of the Public Health Service Act of 1944, as amended. (See subchapter F—Biologics, of this chapter.)", "source": null}]
|
§ 310.3
|
[39 FR 11680, Mar. 29, 1974, as amended at 55 FR 11578, Mar. 29, 1990]
|
Mar. 29, 1974
|
(Revised as of April 1, 1996)
|
False
|
False
|
2 years
|
False
|
True
|
2 years
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:Pt._310:310.103
|
||||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
Pt. 310
|
NEW DRUGS
|
Subpart C
|
New Drugs Exempted From Prescription-Dispensing Requirements
|
310.200
|
Prescription-exemption procedure.
|
(a) Duration of prescription requirement. Any drug limited to prescription use under section 503(b)(1)(C) of the act remains so limited until it is exempted as provided in paragraph (b) or (e) of this section.
(b) Prescription-exemption procedure for drugs limited by a new drug application. Any drug limited to prescription use under section 503(b)(1)(C) of the act shall be exempted from prescription-dispensing requirements when the Commissioner finds such requirements are not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and he finds that the drug is safe and effective for use in self-medication as directed in proposed labeling. A proposal to exempt a drug from the prescription-dispensing requirements of section 503(b)(1)(C) of the act may be initiated by the Commissioner or by any interested person. Any interested person may file a petition seeking such exemption, which petition may be pursuant to part 10 of this chapter, or in the form of a supplement to an approved new drug application.
(c) New drug status of drugs exempted from the prescription requirement. A drug exempted from the prescription requirement under the provisions of paragraph (b) of this section is a “new drug” within the meaning of section 201(p) of the act until it has been used to a material extent and for a material time under such conditions except as provided in paragraph (e) of this section.
(d) Prescription legend not allowed on exempted drugs. The use of the prescription caution statement quoted in section 503(b) (4) of the act, in the labeling of a drug exempted under the provisions of this section, constitutes misbranding. Any other statement or suggestion in the labeling of a drug exempted under this section, that such drug is limited to prescription use, may constitute misbranding.
(e) Prescription-exemption procedure of OTC drug review. A drug limited to prescription use under section 503(b)(1)(C) of the act may also be exempted from prescription-dispensing requirements by the procedure set forth in § 330.13 of this chapter.
|
regulation
|
[{"label": "(a)", "text": "Duration of prescription requirement. Any drug limited to prescription use under section 503(b)(1)(C) of the act remains so limited until it is exempted as provided in paragraph (b) or (e) of this section.", "source": null}, {"label": "(b)", "text": "Prescription-exemption procedure for drugs limited by a new drug application. Any drug limited to prescription use under section 503(b)(1)(C) of the act shall be exempted from prescription-dispensing requirements when the Commissioner finds such requirements are not necessary for the protection of the public health by reason of the drug's toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, and he finds that the drug is safe and effective for use in self-medication as directed in proposed labeling. A proposal to exempt a drug from the prescription-dispensing requirements of section 503(b)(1)(C) of the act may be initiated by the Commissioner or by any interested person. Any interested person may file a petition seeking such exemption, which petition may be pursuant to part 10 of this chapter, or in the form of a supplement to an approved new drug application.", "source": null}, {"label": "(c)", "text": "New drug status of drugs exempted from the prescription requirement. A drug exempted from the prescription requirement under the provisions of paragraph (b) of this section is a “new drug” within the meaning of section 201(p) of the act until it has been used to a material extent and for a material time under such conditions except as provided in paragraph (e) of this section.", "source": null}, {"label": "(d)", "text": "Prescription legend not allowed on exempted drugs. The use of the prescription caution statement quoted in section 503(b) (4) of the act, in the labeling of a drug exempted under the provisions of this section, constitutes misbranding. Any other statement or suggestion in the labeling of a drug exempted under this section, that such drug is limited to prescription use, may constitute misbranding.", "source": null}, {"label": "(e)", "text": "Prescription-exemption procedure of OTC drug review. A drug limited to prescription use under section 503(b)(1)(C) of the act may also be exempted from prescription-dispensing requirements by the procedure set forth in § 330.13 of this chapter.", "source": null}]
|
§ 330.13
|
[39 FR 11680, Mar. 29, 1974, as amended at 41 FR 32582, Aug. 4, 1976; 42 FR 4714, Jan. 25, 1977; 42 FR 15674, Mar. 22, 1977]
|
Mar. 29, 1974
|
(Revised as of April 1, 1996)
|
False
|
False
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:Pt._310:310.200
|
||||||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
Pt. 310
|
NEW DRUGS
|
Subpart C
|
New Drugs Exempted From Prescription-Dispensing Requirements
|
310.201
|
Exemption for certain drugs limited by new-drug applications to prescription sale.
|
(a) The prescription-dispensing requirements of section 503(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act are not necessary for the protection of the public health with respect to the following drugs subject to new drug applications:
(1) N-Acetyl-p-aminophenol (acetaminophen, p-hydroxy-acetanilid) preparations meeting all the following conditions:
(i) The N-acetyl-p-aminophenol is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The N-acetyl-p-aminophenol and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505 (b) of the act is approved for it.
(iv) The preparation contains not more than 0.325 gram (5 grains) of N-acetyl-p-aminophenol per dosage unit, or if it is in liquid form not more than 100 milligrams of N-acetyl-p-aminophenol per milliliter.
(v) The preparation is labeled with adequate directions for use in minor conditions as a simple analgesic.
(vi) The dosages of N-acetyl-p-aminophenol recommended or suggested in the labeling do not exceed: For adults, 0.65 gram (10 grains) per dose or 2.6 grams (40 grains) per 24-hour period: for children 6 to 12 years of age, one-half of the maximum adult dose or dosage; for children 3 to 6 years of age, one-fifth of the maximum adult dose or dosage.
(vii) The labeling bears, in juxtaposition with the dosage recommendations, a clear warning statement against administration of the drug to children under 3 years of age and against use of the drug for more than 10 days, unless such uses are directed by a physician.
(viii) If the article is offered for use in arthritis or rheumatism, the labeling prominently bears a statement that the beneficial effects claimed are limited to the temporary relief of minor aches and pains of arthritis and rheumatism and, in juxtaposition with directions for use in such conditions, a conspicuous warning statement, such as “Caution: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately”.
(2) Sodium gentisate (sodium-2, 5-dihydroxybenzoate) preparations meeting all the following conditions:
(i) The sodium gentisate is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The sodium gentisate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 0.5 gram (7.7 grains) of anhydrous sodium gentisate per dosage unit.
(v) The preparation is labeled with adequate directions for use in minor conditions as a simple analgesic.
(vi) The dosages of sodium gentisate recommended or suggested in the labeling do not exceed: For adults, 0.5 gram (7.7 grains) per dose of 2.0 grams (31 grains) per 24-hour period; for children 6 to 12 years of age, one-half of the maximum adult dose or dosage.
(vii) The labeling bears, in juxtaposition with the dosage recommendations, a clear warning statement against administration of the drug to children under 6 years of age and against use of the drug for a prolonged period, except as such uses may be directed by a physician.
(3) Isoamylhydrocupreine and zolamine hydrochloride (N, N-dimethyl-N′-2-thiazolyl-N′-p-methoxybenzyl-ethyl- enediamine hydrochloride) preparations meeting all the following conditions:
(i) The isoamylhydrocupreine and zolamine hydrochloride are prepared in dosage form suitable for self-medication as rectal suppositories or as an ointment and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The isoamylhydrocupreine, zola-amine hydrochloride, and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 0.25 percent of isoamylhydrocupreine and 1.0 percent of zolamine hydrochloride.
(v) If the preparation is in suppository form, it contains not more than 5.0 milligrams of isoamylhydrocupreine and not more than 20.0 milligrams of zolamine hydrochloride per suppository.
(vi) The preparation is labeled with adequate directions for use in the temporary relief of local pain and itching associated with hemorrhoids.
(vii) The directions provide for the use of not more than two suppositories or two applications of ointment in a 24-hour period.
(viii) The labeling bears, in juxtaposition with the dosage recommendations, a clear warning statement against use of the preparation in case of rectal bleeding, as this may indicate serious disease.
(4) Phenyltoloxamine dihydrogen citrate (N,N-dimethyl-(a-phenyl-O-toloxy) ethylamine dihydrogen citrate), preparations meeting all the following conditions:
(i) The phenyltoloxamine dihydrogen citrate is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The phenyltoloxamine dihydrogen citrate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 88 milligrams of phenyltoloxamine dihydrogen citrate (equivalent to 50 milligrams of phenyltoloxamine) per dosage unit.
(v) The preparation is labeled with adequate directions for use in the temporary relief of the symptoms of hay fever and/or the symptoms of other minor conditions in which it is indicated.
(vi) The dosages recommended or suggested in the labeling do not exceed: For adults, 88 milligrams of phenyltoloxamine dihydrogen citrate (equivalent to 50 milligrams of phenyltoloxamine) per dose or 264 milligrams of phenyltoloxamine dihydrogen citrate (equivalent to 150 milligrams of phenyltoloxamine) per 24-hour period; for children 6 to 12 years of age, one-half of the maximum adult dose or dosage.
(vii) The labeling bears, in juxtaposition with the dosage recommendations:
(a) Clear warning statements against administration of the drug to children under 6 years of age, except as directed by a physician, and against driving a car or operating machinery while using the drug, since it may cause drowsiness.
(b) If the article is offered for temporary relief of the symptoms of colds, a statement that continued administration for such use should not exceed 3 days, except as directed by a physician.
(5)—(7) [Reserved]
(8) Dicyclomine hydrochloride (1-cyclohexylhexahydrobenzoic acid. β-diethylaminoethyl ester hydrochloride; diethylaminocarbethoxy-bicyclohexyl hydrochloride) preparations meeting all the following conditions:
(i) The dicyclomine hydrochloride is prepared with suitable antacid and other components, in tablet or other dosage form for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The dicyclomine hydrochloride and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 5 milligrams of dicyclomine hydrochloride per dosage unit, or if it is in liquid form not more than 0.5 milligram of dicyclomine hydrochloride per milliliter.
(v) The preparation is labeled with adequate directions for use only by adults and children over 12 years of age, in the temporary relief of gastric hyperacidity.
(vi) The dosages recommended or suggested in the directions for use do not exceed 10 milligrams of dicyclomine hydrochloride per dose or 30 milligrams in a 24-hour period.
(vii) The labeling bears, in juxtaposition with the dosage recommendations, clear warning statements against:
(a) Exceeding the recommended dosage.
(b) Prolonged use, except as directed by a physician, since persistent or recurring symptoms may indicate a serious disease requiring medical attention.
(c) Administration to children under 12 years of age except as directed by a physician.
(9) [Reserved]
(10) Sodium fluoride preparations meeting all the following conditions:
(i) The sodium fluoride is prepared, with other components, in a dosage form suitable for household use as a dentifrice powder, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The sodium fluoride and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 5 milligrams of sodium fluoride per gram and is packaged to contain not more than 300 milligrams of sodium fluoride per retail package.
(v) The preparation is labeled with adequate directions for use only as a dentifrice by adults and children 6 years of age and over, and includes instructions to rinse the mouth thoroughly after brushing the teeth.
(vi) The labeling bears, in juxtaposition with the directions for use, a clear warning statement against use by children under 6 years of age.
(11) Hexadenol (a mixture of tetracosanes and their oxidation products) preparations meeting all the following conditions:
(i) The hexadenol is prepared and packaged, with or without other drugs, solvents, and propellants, in a form suitable for self-medication by external application to the skin as a spray, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The hexadenol and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 5 percent by weight of hexadenol.
(v) The preparation is labeled with adequate directions for use by external application in the treatment of minor burns and minor skin irritations.
(vi) The labeling bears, in juxtaposition with the directions for use, clear warning statements against:
(a) Use on serious burns or skin conditions or prolonged use, except as directed by a physician.
(b) Spraying the preparation in the vicinity of eyes, mouth, nose, or ears.
(12) Sulfur dioxide preparations meeting all the following conditions:
(i) The sulfur dioxide is prepared with or without other drugs, in an aqueous solution packaged in a hermetic container suitable for use in self-medication by external application to the skin, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The sulfur dioxide and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 5 grams of sulfur dioxide per 100 milliliters of solution.
(v) The preparation is labeled with adequate directions for use by external application to the smooth skin in the prevention or treatment of minor conditions in which it is indicated.
(vi) The directions for use recommend or suggest not more than two applications a day for not more than 1 week, except as directed by a physician.
(13)-(14)[Reserved]
(15) Sodium monofluorophosphate (Na2PO3F) preparations meeting all the following conditions:
(i) The sodium monofluorophosphate is prepared with other components in an aqueous solution suitable for household use as a dentifrice, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The sodium monofluorophosphate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 60 milligrams of sodium monofluorophosphate per milliliter and is packaged to contain not more than 3.6 grams of sodium monofluorophosphate per retail package.
(v) The preparation is labeled with adequate directions for use only as a dentifrice by adults and children 6 years of age and over, and includes instructions to rinse the mouth thoroughly after brushing the teeth.
(vi) The labeling bears, in juxtaposition with the directions for use, a clear warning statement against use by children under 6 years of age.
(16) Tuaminoheptane sulfate (2-aminoheptane sulfate) preparations meeting all the following conditions:
(i) The tuaminoheptane sulfate is prepared, with or without other drugs, in an aqueous vehicle suitable for administration in self-medication as nose drops, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The preparation is packaged with a style of container or assembly suited to self-medication by the recommended route of administration, and delivering not more than 0.1 milliliter of the preparation per drop.
(iii) The tuaminoheptane sulfate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iv) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(v) The tuaminoheptane sulfate content of the preparation does not exceed 10 milligrams per milliliter.
(vi) The preparation is labeled with adequate directions for use in the temporary relief of nasal congestion.
(vii) The dosages recommended or suggested in the directions for use do not exceed the equivalent: For adults, 5 drops of a 1 percent solution per nostril per dose, and 5 doses in a 24-hour period; for children 1 to 6 years of age, 3 drops of a 1 percent solution per nostril per dose, and 5 doses in a 24-hour period; for infants under 1 year of age, 2 drops of a 1 percent solution per nostril per dose, and 5 doses in a 24-hour period.
(viii) The labeling bears, in juxtaposition with the dosage recommendations:
(a) Clear warning statements against use of more than 5 doses daily, and against use longer than 4 days unless directed by a physician.
(b) A clear warning statement to the effect that frequent use may cause nervousness or sleeplessness, and that individuals with high blood pressure, heart disease, diabetes, or thyroid disease should not use the preparation unless directed by a physician.
(17) [Reserved]
(18) Vibesate (a mixture of copolymers of hydroxy-vinyl chlorideacetate, sebacic acid, and modified maleic rosin ester) preparations meeting all the following conditions.
(i) The vibesate is prepared and packaged, with or without other drugs, solvents, and propellants, in a form suitable for self-medication by external application to the skin as a spray, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The vibesate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 13 percent by weight of vibesate.
(v) The preparation is labeled with adequate directions for use by external application as a dressing for minor burns, minor cuts, or other minor skin irritations.
(vi) The labeling bears in juxtaposition with the directions for use clear warning statements against:
(a) Use on serious burns and on infected, deep, and puncture wounds unless directed by a physician.
(b) Spraying the preparation near the eyes or other mucous membranes.
(c) Inhaling the preparation.
(d) Use near open flames.
(e) Puncturing the container or throwing the container into fire.
(19) Pramoxine hydrochloride (4-N-butoxyphenyl γ-morpholinopropyl ether hydrochloride) preparations meeting all the following conditions:
(i) The pramoxine hydrochloride is prepared, with or without other drugs, in a dosage form suitable for use in self-medication by external application to the skin, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The pramoxine hydrochloride and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 1.0 percent of pramoxine hydrochloride.
(v) The preparation is labeled with adequate directions for use by external application to the skin for the temporary relief of pain or itching due to minor burns and sunburn, nonpoisonous insect bites, and minor skin irritations.
(vi) The directions for use recommend or suggest not more than four applications of the preparation per day, unless directed by a physician.
(vii) The labeling bears, in juxtaposition with the directions for use, clear warning statements against:
(a) Prolonged use.
(b) Application to large areas of the body.
(c) Continued use if redness, irritation, swelling, or pain persists or increases, unless directed by a physician.
(d) Use in the eyes or nose.
(20) Carbetapentane citrate (2-(2-diethylaminoethoxy)-ethyl-1-phenyl- cyclopentyl-1-carboxylate citrate) preparations meeting all the following conditions:
(i) The carbetanentane citrate is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The carbetapentane citrate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, and application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 25 milligrams of carbetapentane citrate per dosage unit; or if it is in liquid form, not more than 1.5 milligrams of carbetapentane citrate per milliliter.
(v) The preparation is labeled with adequate directions for use in the temporary relief of cough due to minor conditions in which it is indicated.
(vi) The dosages recommended or suggested in the labeling do not exceed: For adults, 30 milligrams of carbetapentane citrate per dose or 120 milligrams of carbetapentane citrate per 24-hour period; for children 4 to 12 years of age, 7.5 milligrams per dose or 30 milligrams per 24-hour period; for children 2 to 4 years of age, 4.0 milligrams per dose or 16.0 milligrams per 24-hour period.
(vii) The label bears a conspicuous warning to keep the drug out of the reach of children, and the labeling bears, in juxtaposition with the dosage recommendations:
(a) A clear warning statement against administration of the drug to children under 2 years of age, unless directed by a physician.
(b) Clear warning statements against use of the drug in the presence of high fever or if cough persists, since persistent cough as well as high fever may indicate the presence of a serious condition.
(21) Pamabrom (2-amino-2-methylpropanol-1-8-bromotheophyllinate) preparations meeting all the following conditions:
(i) The pamabrom is prepared with appropriate amounts of a suitable analgesic and with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The pamabrom and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 50 milligrams of pamabrom per dosage unit.
(v) The preparation is labeled with adequate directions for use in the temporary relief of the minor pains and discomforts that may occur a few days before and during the menstrual period.
(vi) The dosages recommended or suggested in the labeling do not exceed 50 milligrams of pamabrom per dose or 200 milligrams per 24-hour period.
(22) Diphemanil methylsulfate (4-diphenylmethylene-1,1-dimethyl-piperidinium methylsulfate) preparations meeting all the following conditions:
(i) The diphemanil methylsulfate is prepared, with or without other drugs, in a dosage form suitable for use in self-medication by external application to the skin, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The diphemanil methylsulfate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 2.0 percent of diphemanil methylsulfate.
(v) The preparation is labeled with adequate directions for use by external application to the skin for the relief of symptoms of mild poison ivy, oak, and sumac and other minor irritations and itching of the skin.
(vi) The directions for use recommend or suggest not more than four applications of the preparation per day, unless directed by a physician.
(vii) The labeling bears, in juxtaposition with the directions for use, a clear warning statement, such as: “Caution: If redness, irritation, swelling, or pain persists or increases, discontinue use and consult physician.”
(23) Dyclonine hydrochloride (4-butoxy-3-piperidinopropiophenone hydrochloride; 4-n-butoxy-β-piperidonopropiophenone hydrochloride) preparations meeting all the following conditions:
(i) The dyclonine hydrochloride is prepared, with or without other drugs, in a dosage form suitable for use as a cream or ointment in self-medication by external application to the skin, or rectally, and contains no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The dyclonine hydrochloride and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 1.0 percent of dyclonine hydrochloride.
(v) The preparation is labeled with adequate directions for use:
(a) By external application to the skin for the temporary relief of pain and itching in sunburn, nonpoisonous insect bites, minor burns, cuts, abrasions, and other minor skin irritations.
(b) [Reserved]
(c) In the prevention or treatment of other minor conditions in which it is indicated.
(vi) The labeling bears, in juxtaposition with the directions for use, clear warning statements against:
(a) Continued use if redness, irritation, swelling, or pain persists or increases, unless directed by a physician.
(b) Use in case of rectal bleeding, as this may indicate serious disease.
(c) Use in the eyes.
(d) Prolonged use.
(e) Application to large areas of the body.
(f) Use for deep or puncture wounds or serious burns.
(24) Chlorothen citrate (chloromethapyrilene citrate; N,N-dimethyl-N′-(2-pyridyl)-N ′-(5-chloro-2-thenyl) ethylenediamine citrate) preparations meeting all the following conditions:
(i) The chlorothen citrate is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The chlorothen citrate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 25 milligrams of chlorothen citrate per dosage unit.
(v) The preparation is labeled with adequate directions for use in the temporary relief of the symptoms of hay fever and/or the symptoms of other minor conditions in which it is indicated.
(vi) The dosages recommended or suggested in the labeling do not exceed: For adults, 25 milligrams of chlorothen citrate per dose or 150 milligrams of chlorothen citrate per 24-hour period; for children 6 to 12 years of age, one-half of the maximum adult dose or dosage.
(vii) The labeling bears, in juxtaposition with the dosage recommendations:
(a) Clear warning statements against administration of the drug to children under 6 years of age or exceeding the recommended dosage, unless directed by a physician, and against driving a car or operating machinery while using the drug, since it may cause drowsiness.
(b) If the article is offered for the temporary relief of symptoms of colds, a statement that continued administration for such use should not exceed 3 days, unless directed by a physician.
(25) [Reserved]
(26) Methoxyphenamine hydrochloride (β-(o-methoxyphenyl)-isopropyl-methylamine hydrochloride; 1-(o-methoxyphenyl)-2-methylamino- propane hydrochloride) preparations meeting all the following conditions:
(i) The methoxyphenamine hydrochloride is prepared with appropriate amounts of a suitable antitussive, with or without other drugs, in a dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The methoxyphenamine hydrochloride and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 3.5 milligrams of methoxyphenamine hydrochloride per milliliter.
(v) The preparation is labeled with adequate directions for use in the temporary relief of cough due to minor conditions in which it is indicated.
(vi) The dosages recommended or suggested in the labeling do not exceed: For adults, 35 milligrams of methoxyphenamine hydrochloride per dose or 140 milligrams of methoxyphenamine hydrochloride per 24-hour period; for children 6 to 12 years of age, one-half of the maximum adult dose or dosage.
(vii) The label bears a conspicuous warning to keep the drug out of the reach of children, and the labeling bears, in juxtaposition with the dosage recommendations:
(a) A clear warning statement against administration of the drug to children under 6 years of age, unless directed by a physician.
(b) A clear warning statement to the effect that frequent or prolonged use may cause nervousness, restlessness, or drowsiness, and that individuals with high blood pressure, heart disease, diabetes, or thyroid disease should not use the preparation unless directed by a physician.
(c) A clear warning statement against use of the drug in the presence of high fever or if cough persists, since persistent cough as well as high fever may indicate the presence of a serious condition.
(27) Biphenamine hydrochloride (β-diethylaminoethyl-3-phenyl-2-hydroxy-benzoate hydrochloride) preparations meeting all the following conditions:
(i) The biphenamine hydrochloride is prepared in a form suitable for use as a shampoo and contains no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.
(ii) The biphenamine hydrochloride meets its professed standards of identity, strength, quality, and purity.
(iii) If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.
(iv) The preparation contains not more than 1 percent of biphenamine hydrochloride.
(v) The preparation is labeled with adequate directions for use for the temporary relief of itching and scaling due to dandruff.
(vi) The label bears a conspicuous warning to keep the drug out of the reach of children.
(28) Tyloxapol (an alkylarylpolyether alcohol) and benzalkonium chloride ophthalmic preparations meeting all the following conditions:
(i) The tyloxapol and benzalkonium chloride are prepared, with other appropriate ingredients which are not drugs limited to prescription sale under the provisions of section 503(b)(1) of the act, as a sterile, isotonic aqueous solution suitable for use in self-medication on eye prostheses.
(ii) The preparation is so packaged as to volume and type of container as to afford adequate protection and be suitable for self-medication with a minimum risk of contamination of the solution during use. Any dispensing unit is sterile and so packaged as to maintain sterility until the package is opened.
(iii) The tyloxapol, benzalkonium chloride, and other ingredients used to prepare the isotonic aqueous solution meet their professed standards of identity, strength, quality, and purity.
(iv) An application pursuant to section 505(b) of the act is approved for the drug.
(v) The preparation contains 0.25 percent of tyloxapol and 0.02 percent of benzalkonium chloride.
(vi) The label bears a conspicuous warning to keep the drug out of the reach of children and the labeling bears, in juxtaposition with the dosage recommendations, a clear warning that if irritation occurs, persists, or increases, use of the drug should be discontinued and a physician consulted. The labeling includes a statement that the dropper or other dispensing tip should not touch any surface, since this may contaminate the solution.
(29) [Reserved]
(b) [Reserved]
|
regulation
|
[{"label": "(a)", "text": "The prescription-dispensing requirements of section 503(b)(1)(C) of the Federal Food, Drug, and Cosmetic Act are not necessary for the protection of the public health with respect to the following drugs subject to new drug applications:", "source": null}, {"label": "(1)", "text": "N-Acetyl-p-aminophenol (acetaminophen, p-hydroxy-acetanilid) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The N-acetyl-p-aminophenol is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The N-acetyl-p-aminophenol and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505 (b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 0.325 gram (5 grains) of N-acetyl-p-aminophenol per dosage unit, or if it is in liquid form not more than 100 milligrams of N-acetyl-p-aminophenol per milliliter.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use in minor conditions as a simple analgesic.", "source": null}, {"label": "(vi)", "text": "The dosages of N-acetyl-p-aminophenol recommended or suggested in the labeling do not exceed: For adults, 0.65 gram (10 grains) per dose or 2.6 grams (40 grains) per 24-hour period: for children 6 to 12 years of age, one-half of the maximum adult dose or dosage; for children 3 to 6 years of age, one-fifth of the maximum adult dose or dosage.", "source": null}, {"label": "(vii)", "text": "The labeling bears, in juxtaposition with the dosage recommendations, a clear warning statement against administration of the drug to children under 3 years of age and against use of the drug for more than 10 days, unless such uses are directed by a physician.", "source": null}, {"label": "(viii)", "text": "If the article is offered for use in arthritis or rheumatism, the labeling prominently bears a statement that the beneficial effects claimed are limited to the temporary relief of minor aches and pains of arthritis and rheumatism and, in juxtaposition with directions for use in such conditions, a conspicuous warning statement, such as “Caution: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately”.", "source": null}, {"label": "(2)", "text": "Sodium gentisate (sodium-2, 5-dihydroxybenzoate) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The sodium gentisate is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The sodium gentisate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 0.5 gram (7.7 grains) of anhydrous sodium gentisate per dosage unit.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use in minor conditions as a simple analgesic.", "source": null}, {"label": "(vi)", "text": "The dosages of sodium gentisate recommended or suggested in the labeling do not exceed: For adults, 0.5 gram (7.7 grains) per dose of 2.0 grams (31 grains) per 24-hour period; for children 6 to 12 years of age, one-half of the maximum adult dose or dosage.", "source": null}, {"label": "(vii)", "text": "The labeling bears, in juxtaposition with the dosage recommendations, a clear warning statement against administration of the drug to children under 6 years of age and against use of the drug for a prolonged period, except as such uses may be directed by a physician.", "source": null}, {"label": "(3)", "text": "Isoamylhydrocupreine and zolamine hydrochloride (N, N-dimethyl-N′-2-thiazolyl-N′-p-methoxybenzyl-ethyl- enediamine hydrochloride) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The isoamylhydrocupreine and zolamine hydrochloride are prepared in dosage form suitable for self-medication as rectal suppositories or as an ointment and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The isoamylhydrocupreine, zola-amine hydrochloride, and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 0.25 percent of isoamylhydrocupreine and 1.0 percent of zolamine hydrochloride.", "source": null}, {"label": "(v)", "text": "If the preparation is in suppository form, it contains not more than 5.0 milligrams of isoamylhydrocupreine and not more than 20.0 milligrams of zolamine hydrochloride per suppository.", "source": null}, {"label": "(vi)", "text": "The preparation is labeled with adequate directions for use in the temporary relief of local pain and itching associated with hemorrhoids.", "source": null}, {"label": "(vii)", "text": "The directions provide for the use of not more than two suppositories or two applications of ointment in a 24-hour period.", "source": null}, {"label": "(viii)", "text": "The labeling bears, in juxtaposition with the dosage recommendations, a clear warning statement against use of the preparation in case of rectal bleeding, as this may indicate serious disease.", "source": null}, {"label": "(4)", "text": "Phenyltoloxamine dihydrogen citrate (N,N-dimethyl-(a-phenyl-O-toloxy) ethylamine dihydrogen citrate), preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The phenyltoloxamine dihydrogen citrate is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The phenyltoloxamine dihydrogen citrate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 88 milligrams of phenyltoloxamine dihydrogen citrate (equivalent to 50 milligrams of phenyltoloxamine) per dosage unit.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use in the temporary relief of the symptoms of hay fever and/or the symptoms of other minor conditions in which it is indicated.", "source": null}, {"label": "(vi)", "text": "The dosages recommended or suggested in the labeling do not exceed: For adults, 88 milligrams of phenyltoloxamine dihydrogen citrate (equivalent to 50 milligrams of phenyltoloxamine) per dose or 264 milligrams of phenyltoloxamine dihydrogen citrate (equivalent to 150 milligrams of phenyltoloxamine) per 24-hour period; for children 6 to 12 years of age, one-half of the maximum adult dose or dosage.", "source": null}, {"label": "(vii)", "text": "The labeling bears, in juxtaposition with the dosage recommendations:", "source": null}, {"label": "(a)", "text": "Clear warning statements against administration of the drug to children under 6 years of age, except as directed by a physician, and against driving a car or operating machinery while using the drug, since it may cause drowsiness.", "source": null}, {"label": "(b)", "text": "If the article is offered for temporary relief of the symptoms of colds, a statement that continued administration for such use should not exceed 3 days, except as directed by a physician.", "source": null}, {"label": "(8)", "text": "Dicyclomine hydrochloride (1-cyclohexylhexahydrobenzoic acid. β-diethylaminoethyl ester hydrochloride; diethylaminocarbethoxy-bicyclohexyl hydrochloride) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The dicyclomine hydrochloride is prepared with suitable antacid and other components, in tablet or other dosage form for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The dicyclomine hydrochloride and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 5 milligrams of dicyclomine hydrochloride per dosage unit, or if it is in liquid form not more than 0.5 milligram of dicyclomine hydrochloride per milliliter.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use only by adults and children over 12 years of age, in the temporary relief of gastric hyperacidity.", "source": null}, {"label": "(vi)", "text": "The dosages recommended or suggested in the directions for use do not exceed 10 milligrams of dicyclomine hydrochloride per dose or 30 milligrams in a 24-hour period.", "source": null}, {"label": "(vii)", "text": "The labeling bears, in juxtaposition with the dosage recommendations, clear warning statements against:", "source": null}, {"label": "(a)", "text": "Exceeding the recommended dosage.", "source": null}, {"label": "(b)", "text": "Prolonged use, except as directed by a physician, since persistent or recurring symptoms may indicate a serious disease requiring medical attention.", "source": null}, {"label": "(c)", "text": "Administration to children under 12 years of age except as directed by a physician.", "source": null}, {"label": "(9)", "text": "[Reserved]", "source": null}, {"label": "(10)", "text": "Sodium fluoride preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The sodium fluoride is prepared, with other components, in a dosage form suitable for household use as a dentifrice powder, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The sodium fluoride and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 5 milligrams of sodium fluoride per gram and is packaged to contain not more than 300 milligrams of sodium fluoride per retail package.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use only as a dentifrice by adults and children 6 years of age and over, and includes instructions to rinse the mouth thoroughly after brushing the teeth.", "source": null}, {"label": "(vi)", "text": "The labeling bears, in juxtaposition with the directions for use, a clear warning statement against use by children under 6 years of age.", "source": null}, {"label": "(11)", "text": "Hexadenol (a mixture of tetracosanes and their oxidation products) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The hexadenol is prepared and packaged, with or without other drugs, solvents, and propellants, in a form suitable for self-medication by external application to the skin as a spray, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The hexadenol and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 5 percent by weight of hexadenol.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use by external application in the treatment of minor burns and minor skin irritations.", "source": null}, {"label": "(vi)", "text": "The labeling bears, in juxtaposition with the directions for use, clear warning statements against:", "source": null}, {"label": "(a)", "text": "Use on serious burns or skin conditions or prolonged use, except as directed by a physician.", "source": null}, {"label": "(b)", "text": "Spraying the preparation in the vicinity of eyes, mouth, nose, or ears.", "source": null}, {"label": "(12)", "text": "Sulfur dioxide preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The sulfur dioxide is prepared with or without other drugs, in an aqueous solution packaged in a hermetic container suitable for use in self-medication by external application to the skin, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The sulfur dioxide and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 5 grams of sulfur dioxide per 100 milliliters of solution.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use by external application to the smooth skin in the prevention or treatment of minor conditions in which it is indicated.", "source": null}, {"label": "(vi)", "text": "The directions for use recommend or suggest not more than two applications a day for not more than 1 week, except as directed by a physician.", "source": null}, {"label": "(15)", "text": "Sodium monofluorophosphate (Na2PO3F) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The sodium monofluorophosphate is prepared with other components in an aqueous solution suitable for household use as a dentifrice, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The sodium monofluorophosphate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 60 milligrams of sodium monofluorophosphate per milliliter and is packaged to contain not more than 3.6 grams of sodium monofluorophosphate per retail package.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use only as a dentifrice by adults and children 6 years of age and over, and includes instructions to rinse the mouth thoroughly after brushing the teeth.", "source": null}, {"label": "(vi)", "text": "The labeling bears, in juxtaposition with the directions for use, a clear warning statement against use by children under 6 years of age.", "source": null}, {"label": "(16)", "text": "Tuaminoheptane sulfate (2-aminoheptane sulfate) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The tuaminoheptane sulfate is prepared, with or without other drugs, in an aqueous vehicle suitable for administration in self-medication as nose drops, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The preparation is packaged with a style of container or assembly suited to self-medication by the recommended route of administration, and delivering not more than 0.1 milliliter of the preparation per drop.", "source": null}, {"label": "(iii)", "text": "The tuaminoheptane sulfate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iv)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(v)", "text": "The tuaminoheptane sulfate content of the preparation does not exceed 10 milligrams per milliliter.", "source": null}, {"label": "(vi)", "text": "The preparation is labeled with adequate directions for use in the temporary relief of nasal congestion.", "source": null}, {"label": "(vii)", "text": "The dosages recommended or suggested in the directions for use do not exceed the equivalent: For adults, 5 drops of a 1 percent solution per nostril per dose, and 5 doses in a 24-hour period; for children 1 to 6 years of age, 3 drops of a 1 percent solution per nostril per dose, and 5 doses in a 24-hour period; for infants under 1 year of age, 2 drops of a 1 percent solution per nostril per dose, and 5 doses in a 24-hour period.", "source": null}, {"label": "(viii)", "text": "The labeling bears, in juxtaposition with the dosage recommendations:", "source": null}, {"label": "(a)", "text": "Clear warning statements against use of more than 5 doses daily, and against use longer than 4 days unless directed by a physician.", "source": null}, {"label": "(b)", "text": "A clear warning statement to the effect that frequent use may cause nervousness or sleeplessness, and that individuals with high blood pressure, heart disease, diabetes, or thyroid disease should not use the preparation unless directed by a physician.", "source": null}, {"label": "(17)", "text": "[Reserved]", "source": null}, {"label": "(18)", "text": "Vibesate (a mixture of copolymers of hydroxy-vinyl chlorideacetate, sebacic acid, and modified maleic rosin ester) preparations meeting all the following conditions.", "source": null}, {"label": "(i)", "text": "The vibesate is prepared and packaged, with or without other drugs, solvents, and propellants, in a form suitable for self-medication by external application to the skin as a spray, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The vibesate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 13 percent by weight of vibesate.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use by external application as a dressing for minor burns, minor cuts, or other minor skin irritations.", "source": null}, {"label": "(vi)", "text": "The labeling bears in juxtaposition with the directions for use clear warning statements against:", "source": null}, {"label": "(a)", "text": "Use on serious burns and on infected, deep, and puncture wounds unless directed by a physician.", "source": null}, {"label": "(b)", "text": "Spraying the preparation near the eyes or other mucous membranes.", "source": null}, {"label": "(c)", "text": "Inhaling the preparation.", "source": null}, {"label": "(d)", "text": "Use near open flames.", "source": null}, {"label": "(e)", "text": "Puncturing the container or throwing the container into fire.", "source": null}, {"label": "(19)", "text": "Pramoxine hydrochloride (4-N-butoxyphenyl γ-morpholinopropyl ether hydrochloride) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The pramoxine hydrochloride is prepared, with or without other drugs, in a dosage form suitable for use in self-medication by external application to the skin, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The pramoxine hydrochloride and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 1.0 percent of pramoxine hydrochloride.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use by external application to the skin for the temporary relief of pain or itching due to minor burns and sunburn, nonpoisonous insect bites, and minor skin irritations.", "source": null}, {"label": "(vi)", "text": "The directions for use recommend or suggest not more than four applications of the preparation per day, unless directed by a physician.", "source": null}, {"label": "(vii)", "text": "The labeling bears, in juxtaposition with the directions for use, clear warning statements against:", "source": null}, {"label": "(a)", "text": "Prolonged use.", "source": null}, {"label": "(b)", "text": "Application to large areas of the body.", "source": null}, {"label": "(c)", "text": "Continued use if redness, irritation, swelling, or pain persists or increases, unless directed by a physician.", "source": null}, {"label": "(d)", "text": "Use in the eyes or nose.", "source": null}, {"label": "(20)", "text": "Carbetapentane citrate (2-(2-diethylaminoethoxy)-ethyl-1-phenyl- cyclopentyl-1-carboxylate citrate) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The carbetanentane citrate is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The carbetapentane citrate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, and application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 25 milligrams of carbetapentane citrate per dosage unit; or if it is in liquid form, not more than 1.5 milligrams of carbetapentane citrate per milliliter.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use in the temporary relief of cough due to minor conditions in which it is indicated.", "source": null}, {"label": "(vi)", "text": "The dosages recommended or suggested in the labeling do not exceed: For adults, 30 milligrams of carbetapentane citrate per dose or 120 milligrams of carbetapentane citrate per 24-hour period; for children 4 to 12 years of age, 7.5 milligrams per dose or 30 milligrams per 24-hour period; for children 2 to 4 years of age, 4.0 milligrams per dose or 16.0 milligrams per 24-hour period.", "source": null}, {"label": "(vii)", "text": "The label bears a conspicuous warning to keep the drug out of the reach of children, and the labeling bears, in juxtaposition with the dosage recommendations:", "source": null}, {"label": "(a)", "text": "A clear warning statement against administration of the drug to children under 2 years of age, unless directed by a physician.", "source": null}, {"label": "(b)", "text": "Clear warning statements against use of the drug in the presence of high fever or if cough persists, since persistent cough as well as high fever may indicate the presence of a serious condition.", "source": null}, {"label": "(21)", "text": "Pamabrom (2-amino-2-methylpropanol-1-8-bromotheophyllinate) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The pamabrom is prepared with appropriate amounts of a suitable analgesic and with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The pamabrom and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 50 milligrams of pamabrom per dosage unit.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use in the temporary relief of the minor pains and discomforts that may occur a few days before and during the menstrual period.", "source": null}, {"label": "(vi)", "text": "The dosages recommended or suggested in the labeling do not exceed 50 milligrams of pamabrom per dose or 200 milligrams per 24-hour period.", "source": null}, {"label": "(22)", "text": "Diphemanil methylsulfate (4-diphenylmethylene-1,1-dimethyl-piperidinium methylsulfate) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The diphemanil methylsulfate is prepared, with or without other drugs, in a dosage form suitable for use in self-medication by external application to the skin, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The diphemanil methylsulfate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 2.0 percent of diphemanil methylsulfate.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use by external application to the skin for the relief of symptoms of mild poison ivy, oak, and sumac and other minor irritations and itching of the skin.", "source": null}, {"label": "(vi)", "text": "The directions for use recommend or suggest not more than four applications of the preparation per day, unless directed by a physician.", "source": null}, {"label": "(vii)", "text": "The labeling bears, in juxtaposition with the directions for use, a clear warning statement, such as: “Caution: If redness, irritation, swelling, or pain persists or increases, discontinue use and consult physician.”", "source": null}, {"label": "(23)", "text": "Dyclonine hydrochloride (4-butoxy-3-piperidinopropiophenone hydrochloride; 4-n-butoxy-β-piperidonopropiophenone hydrochloride) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The dyclonine hydrochloride is prepared, with or without other drugs, in a dosage form suitable for use as a cream or ointment in self-medication by external application to the skin, or rectally, and contains no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The dyclonine hydrochloride and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 1.0 percent of dyclonine hydrochloride.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use:", "source": null}, {"label": "(a)", "text": "By external application to the skin for the temporary relief of pain and itching in sunburn, nonpoisonous insect bites, minor burns, cuts, abrasions, and other minor skin irritations.", "source": null}, {"label": "(b)", "text": "[Reserved]", "source": null}, {"label": "(c)", "text": "In the prevention or treatment of other minor conditions in which it is indicated.", "source": null}, {"label": "(vi)", "text": "The labeling bears, in juxtaposition with the directions for use, clear warning statements against:", "source": null}, {"label": "(a)", "text": "Continued use if redness, irritation, swelling, or pain persists or increases, unless directed by a physician.", "source": null}, {"label": "(b)", "text": "Use in case of rectal bleeding, as this may indicate serious disease.", "source": null}, {"label": "(c)", "text": "Use in the eyes.", "source": null}, {"label": "(d)", "text": "Prolonged use.", "source": null}, {"label": "(e)", "text": "Application to large areas of the body.", "source": null}, {"label": "(f)", "text": "Use for deep or puncture wounds or serious burns.", "source": null}, {"label": "(24)", "text": "Chlorothen citrate (chloromethapyrilene citrate; N,N-dimethyl-N′-(2-pyridyl)-N ′-(5-chloro-2-thenyl) ethylenediamine citrate) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The chlorothen citrate is prepared, with or without other drugs, in tablet or other dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The chlorothen citrate and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 25 milligrams of chlorothen citrate per dosage unit.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use in the temporary relief of the symptoms of hay fever and/or the symptoms of other minor conditions in which it is indicated.", "source": null}, {"label": "(vi)", "text": "The dosages recommended or suggested in the labeling do not exceed: For adults, 25 milligrams of chlorothen citrate per dose or 150 milligrams of chlorothen citrate per 24-hour period; for children 6 to 12 years of age, one-half of the maximum adult dose or dosage.", "source": null}, {"label": "(vii)", "text": "The labeling bears, in juxtaposition with the dosage recommendations:", "source": null}, {"label": "(a)", "text": "Clear warning statements against administration of the drug to children under 6 years of age or exceeding the recommended dosage, unless directed by a physician, and against driving a car or operating machinery while using the drug, since it may cause drowsiness.", "source": null}, {"label": "(b)", "text": "If the article is offered for the temporary relief of symptoms of colds, a statement that continued administration for such use should not exceed 3 days, unless directed by a physician.", "source": null}, {"label": "(25)", "text": "[Reserved]", "source": null}, {"label": "(26)", "text": "Methoxyphenamine hydrochloride (β-(o-methoxyphenyl)-isopropyl-methylamine hydrochloride; 1-(o-methoxyphenyl)-2-methylamino- propane hydrochloride) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The methoxyphenamine hydrochloride is prepared with appropriate amounts of a suitable antitussive, with or without other drugs, in a dosage form suitable for oral use in self-medication, and containing no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The methoxyphenamine hydrochloride and all other components of the preparation meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 3.5 milligrams of methoxyphenamine hydrochloride per milliliter.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use in the temporary relief of cough due to minor conditions in which it is indicated.", "source": null}, {"label": "(vi)", "text": "The dosages recommended or suggested in the labeling do not exceed: For adults, 35 milligrams of methoxyphenamine hydrochloride per dose or 140 milligrams of methoxyphenamine hydrochloride per 24-hour period; for children 6 to 12 years of age, one-half of the maximum adult dose or dosage.", "source": null}, {"label": "(vii)", "text": "The label bears a conspicuous warning to keep the drug out of the reach of children, and the labeling bears, in juxtaposition with the dosage recommendations:", "source": null}, {"label": "(a)", "text": "A clear warning statement against administration of the drug to children under 6 years of age, unless directed by a physician.", "source": null}, {"label": "(b)", "text": "A clear warning statement to the effect that frequent or prolonged use may cause nervousness, restlessness, or drowsiness, and that individuals with high blood pressure, heart disease, diabetes, or thyroid disease should not use the preparation unless directed by a physician.", "source": null}, {"label": "(c)", "text": "A clear warning statement against use of the drug in the presence of high fever or if cough persists, since persistent cough as well as high fever may indicate the presence of a serious condition.", "source": null}, {"label": "(27)", "text": "Biphenamine hydrochloride (β-diethylaminoethyl-3-phenyl-2-hydroxy-benzoate hydrochloride) preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The biphenamine hydrochloride is prepared in a form suitable for use as a shampoo and contains no drug limited to prescription sale under the provisions of section 503(b)(1) of the act.", "source": null}, {"label": "(ii)", "text": "The biphenamine hydrochloride meets its professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iii)", "text": "If the preparation is a new drug, an application pursuant to section 505(b) of the act is approved for it.", "source": null}, {"label": "(iv)", "text": "The preparation contains not more than 1 percent of biphenamine hydrochloride.", "source": null}, {"label": "(v)", "text": "The preparation is labeled with adequate directions for use for the temporary relief of itching and scaling due to dandruff.", "source": null}, {"label": "(vi)", "text": "The label bears a conspicuous warning to keep the drug out of the reach of children.", "source": null}, {"label": "(28)", "text": "Tyloxapol (an alkylarylpolyether alcohol) and benzalkonium chloride ophthalmic preparations meeting all the following conditions:", "source": null}, {"label": "(i)", "text": "The tyloxapol and benzalkonium chloride are prepared, with other appropriate ingredients which are not drugs limited to prescription sale under the provisions of section 503(b)(1) of the act, as a sterile, isotonic aqueous solution suitable for use in self-medication on eye prostheses.", "source": null}, {"label": "(ii)", "text": "The preparation is so packaged as to volume and type of container as to afford adequate protection and be suitable for self-medication with a minimum risk of contamination of the solution during use. Any dispensing unit is sterile and so packaged as to maintain sterility until the package is opened.", "source": null}, {"label": "(iii)", "text": "The tyloxapol, benzalkonium chloride, and other ingredients used to prepare the isotonic aqueous solution meet their professed standards of identity, strength, quality, and purity.", "source": null}, {"label": "(iv)", "text": "An application pursuant to section 505(b) of the act is approved for the drug.", "source": null}, {"label": "(v)", "text": "The preparation contains 0.25 percent of tyloxapol and 0.02 percent of benzalkonium chloride.", "source": null}, {"label": "(vi)", "text": "The label bears a conspicuous warning to keep the drug out of the reach of children and the labeling bears, in juxtaposition with the dosage recommendations, a clear warning that if irritation occurs, persists, or increases, use of the drug should be discontinued and a physician consulted. The labeling includes a statement that the dropper or other dispensing tip should not touch any surface, since this may contaminate the solution.", "source": null}, {"label": "(29)", "text": "[Reserved]", "source": null}, {"label": "(b)", "text": "[Reserved]", "source": null}]
|
[39 FR 11680, Mar. 29, 1974, as amended at 42 FR 36994, July 19, 1977; 52 FR 15892, Apr. 30, 1987; 52 FR 30055, Aug. 12, 1987; 55 FR 31779, Aug. 3, 1990; 57 FR 58374, Dec. 9, 1992; 58 FR 49898, Sept. 23, 1993; 59 FR 4218, Jan. 28, 1994]
|
Mar. 29, 1974
|
(Revised as of April 1, 1996)
|
False
|
False
|
1 week; 3 years; 3 days; 6 years; 10 days; 4 days; 1 year; 4 years; 12 years; 2 years
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:Pt._310:310.201
|
||||||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
Pt. 310
|
NEW DRUGS
|
Subpart D
|
Records and Reports
|
310.303
|
Continuation of long-term studies, records, and reports on certain drugs for which new drug applications have been approved.
|
(a) A new drug may not be approved for marketing unless it has been shown to be safe and effective for its intended use(s). After approval, the applicant is required to establish and maintain records and make reports related to clinical experience or other data or information necessary to make or facilitate a determination of whether there are or may be grounds under section 505(e) of the act for suspending or withdrawing approval of the application. Some drugs, because of the nature of the condition for which they are intended, must be used for long periods of time—even a lifetime. To acquire necessary data for determining the safety and effectiveness of long-term use of such drugs, extensive animal and clinical tests are required as a condition of approval. Nonetheless, the therapeutic or prophylactic usefulness of such drugs may make it inadvisable in the public interest to delay the availability of the drugs for widespread clinical use pending completion of such long-term studies. In such cases, the Food and Drug Administration may approve the new drug application on condition that the necessary long-term studies will be conducted and the results recorded and reported in an organized fashion. The procedures required by paragraph (b) of this section will be followed in order to list such a drug in § 310.304.
(b) A proposal to require additional or continued studies with a drug for which a new drug application has been approved may be made by the Commissioner on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter. Prior to issuance of such a proposal, the applicant will be provided an opportunity for a conference with representatives of the Food and Drug Administration. When appropriate, investigators or other individuals may be invited to participate in the conference. All requirements for special studies, records, and reports will be published in § 310.304.
|
regulation
|
[{"label": "(a)", "text": "A new drug may not be approved for marketing unless it has been shown to be safe and effective for its intended use(s). After approval, the applicant is required to establish and maintain records and make reports related to clinical experience or other data or information necessary to make or facilitate a determination of whether there are or may be grounds under section 505(e) of the act for suspending or withdrawing approval of the application. Some drugs, because of the nature of the condition for which they are intended, must be used for long periods of time—even a lifetime. To acquire necessary data for determining the safety and effectiveness of long-term use of such drugs, extensive animal and clinical tests are required as a condition of approval. Nonetheless, the therapeutic or prophylactic usefulness of such drugs may make it inadvisable in the public interest to delay the availability of the drugs for widespread clinical use pending completion of such long-term studies. In s", "source": null}, {"label": "(b)", "text": "A proposal to require additional or continued studies with a drug for which a new drug application has been approved may be made by the Commissioner on his own initiative or on the petition of any interested person, pursuant to part 10 of this chapter. Prior to issuance of such a proposal, the applicant will be provided an opportunity for a conference with representatives of the Food and Drug Administration. When appropriate, investigators or other individuals may be invited to participate in the conference. All requirements for special studies, records, and reports will be published in § 310.304.", "source": null}]
|
§ 310.304.
|
[39 FR 11680, Mar. 29, 1974, as amended at 41 FR 4714, Jan. 25, 1976; 42 FR 15674, Mar. 22, 1977]
|
Mar. 29, 1974
|
(Revised as of April 1, 1996)
|
False
|
False
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:Pt._310:310.303
|
||||||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
Pt. 310
|
NEW DRUGS
|
Subpart D
|
Records and Reports
|
310.304
|
Drugs that are subjects of approved new drug applications and that require special studies, records, and reports.
|
Listed below are the new drugs and requirements referred to in § 310.303:
(a) [Reserved]
(b) Methadone. Methadone may be used as an analgesic in severe pain, for the detoxification of narcotic addicts, and as an oral substitute for heroin or other morphine-like drugs, in the maintenance treatment of narcotic addicts, pursuant to the conditions established in § 291.505. Further data and information are required to establish the safety and effectiveness of methadone under a variety of conditions during widespread and long-term use. In view of the tremendous public health and social problems associated with the use of heroin, the demonstrated usefulness of methadone in treatment, the lack of a safe and effective alternative drug or treatment modality, the need for additional safety and effectiveness data on methadone for narcotic addict treatment and the danger to health that could be created by uncontrolled distribution and use of methadone for narcotic addict treatment, the Commissioner of Food and Drugs finds that it is not in the public interest either to withhold the drug from the market until it has been proved safe and effective under all conditions of use for narcotic addict treatment or to grant full approval for unrestricted distribution, prescription, dispensing, or administration of methadone for this use. The Commissioner therefore concludes that it is essential to the public interest to prescribe detailed conditions for safe and effective use of methadone for narcotic addict treatment, utilizing the IND and NDA control mechanisms and the authority granted under the Comprehensive Drug Abuse Prevention and Control Act of 1970, to assure that the required additional information for assessing the safety and effectiveness of methadone is obtained, to maintain close control over the safe distribution, administration, and dispensing of the drug, and to detail responsibilities for such control. The conditions established in § 291.505 constitute a determination of the appropriate methods of professional practice in the medical treatment of the narcotic addiction of various classes of narcotic addicts with respect to the use of methadone, pursuant to section 4 of the Comprehensive Drug Abuse Prevention and Control Act of 1970.
|
regulation
|
[{"label": "(a)", "text": "[Reserved]", "source": null}, {"label": "(b)", "text": "Methadone. Methadone may be used as an analgesic in severe pain, for the detoxification of narcotic addicts, and as an oral substitute for heroin or other morphine-like drugs, in the maintenance treatment of narcotic addicts, pursuant to the conditions established in § 291.505. Further data and information are required to establish the safety and effectiveness of methadone under a variety of conditions during widespread and long-term use. In view of the tremendous public health and social problems associated with the use of heroin, the demonstrated usefulness of methadone in treatment, the lack of a safe and effective alternative drug or treatment modality, the need for additional safety and effectiveness data on methadone for narcotic addict treatment and the danger to health that could be created by uncontrolled distribution and use of methadone for narcotic addict treatment, the Commissioner of Food and Drugs finds that it is not in the public interest either to withhold the drug fr", "source": null}]
|
§ 310.303; § 291.505.; § 291.505
|
[39 FR 11680, Mar. 29, 1974, as amended at 41 FR 9546, Mar. 5, 1976; 41 FR 28263, July 9, 1976; 42 FR 46710, Sept. 16, 1977]
|
Mar. 29, 1974
|
(Revised as of April 1, 1996)
|
False
|
False
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:Pt._310:310.304
|
||||||||||||
21
|
Food and Drugs
|
I
|
Food and Drug Administration, Department of Health and Human Services (Continued)
|
D
|
DRUGS FOR HUMAN USE
|
Pt. 310
|
NEW DRUGS
|
Subpart D
|
Records and Reports
|
310.305
|
Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
|
(a) Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of:
(1) All serious, unexpected adverse drug experiences associated with the use of their drug products;
(2) Any significant increase in the frequency of a serious, expected adverse drug experience; and
(3) Any significant increase in the frequency of therapeutic failure (lack of effect).
These reports will enable FDA to protect the public health by helping to monitor the safety of marketed drug products and to ensure that these drug products are not adulterated or misbranded.
(b) Definitions. The following definitions of terms apply to this section:
(1) FDA means the Food and Drug Administration.
(2) Adverse drug experience means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.
(3) Unexpected means an adverse drug experience that is not listed in the current labeling for the drug product and includes an event that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differs from the event because of greater severity or specificity. For example, under this definition, hepatic necrosis would be unexpected (by virtue of greater severity) if the labeling only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the labeling only listed cerebral vascular accidents.
(4) Serious means an adverse drug experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose.
(5) Increased frequency means an increase in the rate of occurrence of a particular adverse drug experience, e.g., an increased number of reports of a particular adverse drug experience after appropriate adjustment for drug exposure.
(c) Reporting requirements—15-day “Alert reports.” (1)(i) Any person whose name appears on the label of a marketed prescription drug product as its manufacturer, packer, or distributor shall report to FDA each adverse drug experience received or otherwise obtained that is both serious and unexpected as soon as possible but in any case within 15 working days of initial receipt of the information. Each report shall be accompanied by a copy of the current labeling for the drug product.
(ii) A person identified in paragraph (c)(1)(i) of this section is not required to submit a 15-day “Alert report” for an adverse drug experience obtained from a postmarketing study (whether or not conducted under an investigational new drug application) unless the applicant concludes that there is a reasonable possibility that the drug caused the adverse experience.
(2) Each person identified in paragraph (c)(1) of this section shall submit one copy of each report to the Division of Epidemiology and Surveillance (HFD-730), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
(3) Each person identified in paragraph (c)(1) of this section shall promptly investigate all serious, unexpected adverse drug experiences that are the subject of these 15-day Alert reports and shall submit followup reports within 15 working days of receipt of new information or as requested by FDA. If additional information is not obtainable, a followup report may be required that describes briefly the steps taken to seek additional information and the reasons why it could not be obtained.
(4) Each person identified in paragraph (c)(1) of this section shall review periodically (at least once each year) the frequency of reports of adverse drug experiences that are both serious and expected and reports of therapeutic failure (lack of effect), received or otherwise obtained, and report any significant increase in frequency as soon as possible but in any case within 15 working days of determining that a significant increase in frequency exists. Reports of a significant increase in frequency are required to be submitted in narrative form (including the time period on which the increased frequency is based, the method of analysis, and the interpretation of the results), rather than using Form FDA-1639.
(5) In order to avoid unnecessary duplication in the submission of, and followup to, reports required in this section, including reports required by paragraph (c)(4) of this section, a packer's or distributor's obligations may be met by submission of all reports of serious adverse drug experiences to the manufacturer of the drug product. If a packer or distributor elects to submit these adverse drug experience reports to the manufacturer rather than to FDA, it shall submit each report to the manufacturer within 3 working days of its receipt by the packer or distributor, and the manufacturer shall then comply with the requirements of this section even if its name does not appear on the label of the drug product. Under this circumstance, the packer or distributor shall maintain a record of this action which shall include:
(i) A copy of each drug experience report.
(ii) Date the report was received by the packer or distributor.
(iii) Date the report was submitted to the manufacturer.
(iv) Name and address of the manufacturer.
(6) Each report submitted to FDA under this section shall bear prominent identification as to its contents, i.e., “15-day Alert report” or “15-day Alert report—followup.”
(d) Reporting form. (1) Except as provided in paragraph (d)(3) of this section, each person identified in paragraph (c)(1) of this section shall submit each report of a serious and unexpected adverse drug experience on a Form FDA-1639 (Adverse Reaction Report).
(2) Each completed Form FDA-1639 should pertain only to an individual patient.
(3) Instead of using Form FDA-1639, a manufacturer, packer, or distributor may use a computer-generated FDA-1639 or other alternative format (e.g., a computer-generated tape or tabular listing) provided that:
(i) The content of the alternative format is equivalent in all elements of information to those specified in Form FDA-1639, and
(ii) The format is agreed to in advance by the Division of Epidemiology and Surveillance (HFD-730).
(4) Single copies of Form FDA-1639 may be obtained from the Division of Epidemiology and Surveillance (HFD-730), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Supplies of Form FDA-1639 may be obtained from the PHS Forms and Publications Distribution Center, 12100 Parklawn Dr., Rockville, MD 20857.
(e) Patient privacy. Manufacturers, packers, and distributors should not include in reports under this section the names and addresses of individual patients; instead, the manufacturer, packer, and distributor should assign a unique code number to each report, preferably not more than eight characters in length. The manufacturer, packer, and distributor should include the name of the reporter from whom the information was received. Names of patients, individual reporters, health care professionals, hospitals, and geographical identifiers in adverse drug experience reports are not releasable to the public under FDA's public information regulations in part 20 of this chapter.
(f) Recordkeeping. (1) Each manufacturer, packer, and distributor shall maintain for a period of 10 years records of all adverse drug experiences required under this section to be reported or reviewed periodically for a significant increase in frequency, including raw data and any correspondence relating to the adverse drug experiences, and the records required to be maintained under paragraph (c)(5) of this section.
(2) Manufacturers and packers may retain the records required in paragraph (f)(1) of this section as part of its complaint files maintained under § 211.198 of this chapter.
(3) Manufacturers, packers, and distributors shall permit any authorized FDA employee, at all reasonable times, to have access to and copy and verify the records established and maintained under this section.
(g) Disclaimer. A report or information submitted by a manufacturer, packer, or distributor under this section (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the manufacturer, packer, or distributor, or by FDA, that the report or information constitutes an admission that the drug caused or contributed to an adverse effect. The manufacturer, packer, or distributor need not admit, and may deny, that the report or information submitted under this section constitutes an admission that the drug caused or contributed to an adverse effect.
(Collection of information requirements approved by the Office of Management and Budget under control number 0910-0210)
|
regulation
|
[{"label": "(a)", "text": "Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of:", "source": null}, {"label": "(1)", "text": "All serious, unexpected adverse drug experiences associated with the use of their drug products;", "source": null}, {"label": "(2)", "text": "Any significant increase in the frequency of a serious, expected adverse drug experience; and", "source": null}, {"label": "(3)", "text": "Any significant increase in the frequency of therapeutic failure (lack of effect).", "source": null}, {"label": "(b)", "text": "Definitions. The following definitions of terms apply to this section:", "source": null}, {"label": "(1)", "text": "FDA means the Food and Drug Administration.", "source": null}, {"label": "(2)", "text": "Adverse drug experience means any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.", "source": null}, {"label": "(3)", "text": "Unexpected means an adverse drug experience that is not listed in the current labeling for the drug product and includes an event that may be symptomatically and pathophysiologically related to an event listed in the labeling, but differs from the event because of greater severity or specificity. For example, under this definition, hepatic necrosis would be unexpected (by virtue of greater severity) if the labeling only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the labeling only listed cerebral vascular accidents.", "source": null}, {"label": "(4)", "text": "Serious means an adverse drug experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose.", "source": null}, {"label": "(5)", "text": "Increased frequency means an increase in the rate of occurrence of a particular adverse drug experience, e.g., an increased number of reports of a particular adverse drug experience after appropriate adjustment for drug exposure.", "source": null}, {"label": "(c)", "text": "Reporting requirements—15-day “Alert reports.” (1)(i) Any person whose name appears on the label of a marketed prescription drug product as its manufacturer, packer, or distributor shall report to FDA each adverse drug experience received or otherwise obtained that is both serious and unexpected as soon as possible but in any case within 15 working days of initial receipt of the information. Each report shall be accompanied by a copy of the current labeling for the drug product.", "source": null}, {"label": "(ii)", "text": "A person identified in paragraph (c)(1)(i) of this section is not required to submit a 15-day “Alert report” for an adverse drug experience obtained from a postmarketing study (whether or not conducted under an investigational new drug application) unless the applicant concludes that there is a reasonable possibility that the drug caused the adverse experience.", "source": null}, {"label": "(2)", "text": "Each person identified in paragraph (c)(1) of this section shall submit one copy of each report to the Division of Epidemiology and Surveillance (HFD-730), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.", "source": null}, {"label": "(3)", "text": "Each person identified in paragraph (c)(1) of this section shall promptly investigate all serious, unexpected adverse drug experiences that are the subject of these 15-day Alert reports and shall submit followup reports within 15 working days of receipt of new information or as requested by FDA. If additional information is not obtainable, a followup report may be required that describes briefly the steps taken to seek additional information and the reasons why it could not be obtained.", "source": null}, {"label": "(4)", "text": "Each person identified in paragraph (c)(1) of this section shall review periodically (at least once each year) the frequency of reports of adverse drug experiences that are both serious and expected and reports of therapeutic failure (lack of effect), received or otherwise obtained, and report any significant increase in frequency as soon as possible but in any case within 15 working days of determining that a significant increase in frequency exists. Reports of a significant increase in frequency are required to be submitted in narrative form (including the time period on which the increased frequency is based, the method of analysis, and the interpretation of the results), rather than using Form FDA-1639.", "source": null}, {"label": "(5)", "text": "In order to avoid unnecessary duplication in the submission of, and followup to, reports required in this section, including reports required by paragraph (c)(4) of this section, a packer's or distributor's obligations may be met by submission of all reports of serious adverse drug experiences to the manufacturer of the drug product. If a packer or distributor elects to submit these adverse drug experience reports to the manufacturer rather than to FDA, it shall submit each report to the manufacturer within 3 working days of its receipt by the packer or distributor, and the manufacturer shall then comply with the requirements of this section even if its name does not appear on the label of the drug product. Under this circumstance, the packer or distributor shall maintain a record of this action which shall include:", "source": null}, {"label": "(i)", "text": "A copy of each drug experience report.", "source": null}, {"label": "(ii)", "text": "Date the report was received by the packer or distributor.", "source": null}, {"label": "(iii)", "text": "Date the report was submitted to the manufacturer.", "source": null}, {"label": "(iv)", "text": "Name and address of the manufacturer.", "source": null}, {"label": "(6)", "text": "Each report submitted to FDA under this section shall bear prominent identification as to its contents, i.e., “15-day Alert report” or “15-day Alert report—followup.”", "source": null}, {"label": "(d)", "text": "Reporting form. (1) Except as provided in paragraph (d)(3) of this section, each person identified in paragraph (c)(1) of this section shall submit each report of a serious and unexpected adverse drug experience on a Form FDA-1639 (Adverse Reaction Report).", "source": null}, {"label": "(2)", "text": "Each completed Form FDA-1639 should pertain only to an individual patient.", "source": null}, {"label": "(3)", "text": "Instead of using Form FDA-1639, a manufacturer, packer, or distributor may use a computer-generated FDA-1639 or other alternative format (e.g., a computer-generated tape or tabular listing) provided that:", "source": null}, {"label": "(i)", "text": "The content of the alternative format is equivalent in all elements of information to those specified in Form FDA-1639, and", "source": null}, {"label": "(ii)", "text": "The format is agreed to in advance by the Division of Epidemiology and Surveillance (HFD-730).", "source": null}, {"label": "(4)", "text": "Single copies of Form FDA-1639 may be obtained from the Division of Epidemiology and Surveillance (HFD-730), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Supplies of Form FDA-1639 may be obtained from the PHS Forms and Publications Distribution Center, 12100 Parklawn Dr., Rockville, MD 20857.", "source": null}, {"label": "(e)", "text": "Patient privacy. Manufacturers, packers, and distributors should not include in reports under this section the names and addresses of individual patients; instead, the manufacturer, packer, and distributor should assign a unique code number to each report, preferably not more than eight characters in length. The manufacturer, packer, and distributor should include the name of the reporter from whom the information was received. Names of patients, individual reporters, health care professionals, hospitals, and geographical identifiers in adverse drug experience reports are not releasable to the public under FDA's public information regulations in part 20 of this chapter.", "source": null}, {"label": "(f)", "text": "Recordkeeping. (1) Each manufacturer, packer, and distributor shall maintain for a period of 10 years records of all adverse drug experiences required under this section to be reported or reviewed periodically for a significant increase in frequency, including raw data and any correspondence relating to the adverse drug experiences, and the records required to be maintained under paragraph (c)(5) of this section.", "source": null}, {"label": "(2)", "text": "Manufacturers and packers may retain the records required in paragraph (f)(1) of this section as part of its complaint files maintained under § 211.198 of this chapter.", "source": null}, {"label": "(3)", "text": "Manufacturers, packers, and distributors shall permit any authorized FDA employee, at all reasonable times, to have access to and copy and verify the records established and maintained under this section.", "source": null}, {"label": "(g)", "text": "Disclaimer. A report or information submitted by a manufacturer, packer, or distributor under this section (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the manufacturer, packer, or distributor, or by FDA, that the report or information constitutes an admission that the drug caused or contributed to an adverse effect. The manufacturer, packer, or distributor need not admit, and may deny, that the report or information submitted under this section constitutes an admission that the drug caused or contributed to an adverse effect.", "source": null}]
|
§ 211.198
|
[51 FR 24779, July 3, 1986, as amended at 52 FR 37936, Oct. 13, 1987; 55 FR 11578, Mar. 29, 1990; 57 FR 17980, Apr. 28, 1993]
|
July 3, 1986
|
(Revised as of April 1, 1996)
|
False
|
True
|
Adverse drug experience; Increased frequency
|
10 years
|
False
|
False
|
CFR
|
1996
|
CFR-1996-title21-vol5.xml
|
https://www.govinfo.gov/bulkdata/CFR/1996/title-21
|
cfr:1996:21:Pt._310:310.305
|
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