Summary:
Label and Transport Tissues Safely Act of 2014 or the LATTS Act of 2014 - Sets forth guidelines for handling human tissue specimens.

Prohibits sale of human tissue for research or education unless the seller has a non-transplant tissue bank license and each package of tissue is labeled with specified information.

Directs the Secretary of Health and Human Services (HHS) to establish a process for the approval, suspension, and revocation of non-transplant tissue bank licenses.

Prohibits falsely labeling packages of human tissue.

Allows HHS or any accrediting body authorized by HHS to enter and inspect any establishment engaged in the preparation of any human tissue specimen.

Requires HHS to recall any human tissue specimen that is an imminent or substantial hazard to public health.

safely act act sets forth guidelines handling human tissue specimens prohibits sale human tissue research education seller non transplant tissue bank license package tissue labeled specified information directs secretary health_and_human_services hhs establish process approval suspension revocation non transplant tissue bank licenses prohibits falsely labeling packages human tissue accrediting body authorized hhs enter inspect establishment engaged preparation human tissue specimen requires hhs recall human tissue specimen imminent substantial hazard public health


Summary:
Protecting Our Kids' Medicine Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of liquid formulations of over-the-counter drugs that are not packaged with a dosage delivery device, such as a calibrated cup or spoon, and that do not have measurements on the label and on the dosage delivery device exclusively in metric units. Allows the Secretary of Health and Human Services (HHS) to waive the requirement for metric units if that requirement would not benefit public health.

Prohibits the sale of over-the-counter liquid drugs labeled for pediatric use that do not have a flow restrictor or another mechanism to reduce accidental ingestion.

protecting kids medicine act amends cosmetic act prohibit sale liquid formulations counter drugs packaged dosage delivery device cup measurements label dosage delivery device exclusively metric units allows secretary health_and_human_services hhs waive requirement metric units requirement benefit public health prohibits sale counter liquid drugs labeled pediatric use flow mechanism reduce accidental ingestion


Summary:
Fair Access for Safe and Timely Generics Act of 2014 or the FAST Generics Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug from restricting availability of the drug for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with any aspect of a risk evaluation and mitigation strategy (REMS).

Directs the Secretary to authorize product developers to obtain approved drugs for testing if the product developer is a license holder of an approved drug or the Secretary determines the product developer can comply with laws applicable to drug development.

Requires the Secretary to authorize a product developer to conduct human clinical trials with an approved drug if the product developer's clinical trial protocol includes protections comparable to the distribution restrictions on the approved drug.

Establishes a process for a product developer to obtain reasonable quantities of an approved drug when those quantities are not available commercially.

Allows the Secretary to prohibit or limit transfer of an approved drug to a product developer if the transfer poses an imminent hazard to public health.

Eliminates license holder liability for claims arising from a product developer's testing of an approved drug.

Requires the FDA and the Federal Trade Commission (FTC) to report on noncompliance with this Act.

Allows the Secretary to waive the requirement that a drug use a single, shared system of elements to assure safe use with a comparable approved drug if the developer of the drug is unable to finalize terms for a shared system with the license holder of the approved drug.

fast amends cosmetic act require secretary health_and_human_services hhs prohibit license holder food_and_drug_administration drug restricting availability drug testing product developer seeking develop drug generic drug biosimilar including restricting availability aspect risk evaluation mitigation strategy directs secretary authorize product developers obtain approved drugs testing product developer license holder approved drug secretary determines product developer comply laws applicable drug development requires secretary authorize product developer conduct human clinical trials approved drug product developer clinical trial protocol includes protections comparable distribution restrictions approved drug establishes process product developer obtain reasonable quantities approved drug quantities available commercially allows secretary prohibit limit transfer approved drug product developer transfer poses imminent hazard public health eliminates license holder liability claims arising product developer testing approved drug requires fda federal_trade_commission ftc report noncompliance act allows secretary waive requirement drug use single shared system elements assure safe use comparable approved drug developer drug unable finalize terms shared system license holder approved drug


Summary: Medicaid Generic Drug Price Fairness Act of 2014 - Amends title XIX (Medicaid) of the Social Security Act to extend to manufacturers of generic drugs the requirement that drug manufacturers in certain circumstances pay an additional rebate to state Medicaid programs.

fairness act amends title xix medicaid social security act extend manufacturers generic drugs requirement drug manufacturers certain circumstances pay additional rebate state medicaid programs


Summary:
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an “orphan disease”).

Allows the Secretary to revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement.

Requires the sponsor of a product receiving an extension to notify HHS one year prior to discontinuing production for commercial reasons.

Requires the Secretary to notify the public of products that receive this extension.

Limits a product to one extension under this Act. Sets forth that extensions under this Act are in addition to other extensions.

Applies only to products approved after enactment of this Act for a new indication that is a rare disease or condition.

accelerating cures treatments act amends cosmetic act require secretary health_and_human_services hhs extend months exclusivity period drug biological product approved food_and_drug_administration fda product additionally approved prevent diagnose treat new indication rare disease condition known orphan disease allows secretary revoke extension application submitted fda new indication contained untrue material statement requires sponsor product receiving extension notify hhs year prior discontinuing production commercial reasons requires secretary notify public products receive extension limits product extension act sets forth extensions act addition extensions applies products approved enactment act new indication rare disease condition


Summary:
Andrea Sloan Compassionate Use Reform and Enhancement Act or the Andrea Sloan CURE Act - Amends the Federal Food, Drug, and Cosmetic Act to require the sponsor of a “breakthrough drug” (which is a drug that qualifies for expedited approval, is an infectious disease product, or qualifies the sponsor for a priority review voucher) to submit to the Secretary of Health and Human Services (HHS) and make available to the public a policy on requests for access to the drug for compassionate use, including the minimum criteria for consideration or approval of requests and the time needed to make a decision.

Requires a breakthrough drug sponsor to explain a denied request for compassionate use to the person who made the request.

Directs HHS to establish an Expanded Access Task Force. Requires the Task Force and the Government Accountability Office (GAO) to evaluate patient access to investigational drugs and make recommendations for improving access.

Directs HHS to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO.

compassionate use reform enhancement act sloan cure act amends federal food drug cosmetic act require sponsor breakthrough drug drug qualifies expedited approval infectious disease product qualifies sponsor priority review voucher submit secretary health_and_human_services hhs available public policy requests access drug compassionate use including minimum criteria consideration approval requests time needed decision requires breakthrough drug sponsor explain denied request compassionate use person request directs hhs establish requires task force government_accountability_office gao evaluate patient access investigational drugs recommendations improving access directs hhs finalize draft guidance entitled expanded access investigational drugs treatment use taking account reports task_force gao


Summary:
Protecting Access to Diabetes Supplies Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to revise the special competitive acquisition program rule applied to diabetic testing strips to require the volume for such types of products to be determined through the use of multiple sources of data that measure consumption and utilization of such strips among individuals in the United States.

Directs the Secretary of Health and Human Services to reject any bid submitted by an entity under the competitive acquisition program that does not demonstrate that it can furnish the types of strips included in its bid.

Requires an entity to furnish to an individual the brand of strips compatible with the individual's home blood glucose monitor.

Prohibits an entity from attempting to influence or incentivize an individual to switch the brand of glucose monitor or testing strips selected.

Prohibits an entity from communicating directly to such an individual until it has given the individual verbally standardized information about the individual's rights with respect to the entity.

Directs the Secretary to establish a process under which an individual furnished with diabetic testing strips under a competitive acquisition program may reject them by notifying the supplier and the Secretary. Permits the individual to obtain different strips from another supplier and have a new claim processed.

amends title xviii medicare social security act revise special competitive acquisition program rule applied diabetic testing strips require volume types products determined use multiple sources data measure consumption utilization strips individuals united_states directs secretary health_and_human_services reject bid submitted entity competitive acquisition program demonstrate furnish types strips included bid requires entity furnish individual brand strips compatible individual home blood glucose monitor prohibits entity attempting influence incentivize individual switch brand glucose monitor testing strips selected prohibits entity communicating directly individual given individual standardized information individual rights respect entity directs secretary establish process individual furnished diabetic testing strips competitive acquisition program reject notifying supplier secretary permits individual obtain different strips supplier new claim processed


Summary:
Medicare DMEPOS Competitive Bidding Improvement Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act with respect to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program.

Prohibits the Secretary of Health and Human Services (HHS) from accepting a bid from an entity for an area unless it: (1) meets state licensure requirements for the area for all items in the submitted bid for a product category, and (2) has obtained a bid surety bond of between $50,000 and $100,000 for each such area.

Prescribes requirements for the treatment of losing bidders and successful bidders that do not accept a contract.

medicare dmepos competitive bidding improvement act amends title xviii medicare social security act respect medicare durable medical equipment prosthetics orthotics supplies dmepos competitive acquisition program prohibits secretary health_and_human_services hhs accepting bid entity area meets state licensure requirements area items submitted bid product category obtained bid surety bond area prescribes requirements treatment losing bidders successful bidders accept contract


Summary: Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the importation, distribution, or sale of investigational drugs or devices for terminally ill patients.

amends cosmetic act declare public_health_service act shall prevent restrict food_and_drug_administration fda shall implement enforce law prevent restrict importation distribution sale investigational drugs devices terminally ill patients


Summary:
Tim Fagan's Law or Counterfeit Drug Enforcement Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for a drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Department of Health and Human Services (HHS) within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred.

Deems a drug to be misbranded if it is not manufactured using technologies that HHS determines are technically feasible and assist in preventing such violations.

Authorizes additional appropriations for Food and Drug Administration (FDA) inspections, examinations, and investigations.

Requires HHS to educate the public and health care professionals on counterfeit drugs.

Directs HHS, upon a finding that a drug intended for human use may constitute a threat to the public health, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering, distributing, selling, or prescribing the drug. Requires HHS, after providing the person with an opportunity for an informal hearing, to amend the order to include a recall, if appropriate.

Requires HHS and the Attorney General to establish a procedure through which the FDA is authorized to issue subpoenas.

counterfeit drug enforcement act amends cosmetic act ffdca establish criminal fine imprisonment person knowingly causes prescription drug adulterated misbranded misrepresented approved prescription drug sells trades drug purchases trades drug knowing having reason know drug knowingly adulterated misbranded misrepresented requires manufacturer drug notify department_of_health_and_human_services hhs hours receiving aware information reasonably suggests violation occurred deems drug misbranded manufactured technologies hhs determines technically feasible assist preventing violations authorizes additional appropriations food_and_drug_administration fda inspections examinations investigations requires hhs educate public health care professionals counterfeit drugs directs hhs finding drug intended human use constitute threat public health issue order requiring appropriate person including manufacturers importers distributors retailers drug cease distribution drug notify instruct health professionals cease administering distributing selling prescribing drug providing person opportunity informal hearing amend order include recall appropriate requires hhs attorney general establish procedure fda authorized issue subpoenas


Summary:
Preserve Access to Affordable Generics Act - Amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding against parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug for any period of time. Allows an exception to such presumption if the parties to the agreement demonstrate by clear and convincing evidence, based on specified competitive factors, that the pro-competitive benefits of the agreement outweigh the anticompetitive effects.

Exempts from the restrictions of this Act a resolution or settlement of a patent infringement claim if the only consideration granted by the brand name manufacturer to the generic manufacturer is: (1) the right to market the generic drug in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right or other statutory exclusivity that would prevent the marketing of such drug, (2) a payment for reasonable litigation expenses not exceeding $7.5 million, and (3) a covenant not to sue on any claim that the generic drug infringes a U.S. patent.

Allows review of FTC enforcement orders under this Act in federal court. Imposes civil penalties for violations of this Act.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, or sale of the brand name or generic drug or the exclusivity period. Requires the Chief Executive Officer or the company official responsible for negotiating any such agreement to file a certification that materials filed with respect to such agreement are complete, final, and exclusive.

Amends the Federal Food, Drug, and Cosmetic Act to forfeit the 180-day exclusivity period for the marketing of a generic drug if there is a final decision of the FTC or a court that an agreement has violated this Act.

Grants the FTC exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic brand drugs. Establishes a three-year limitation period for bringing FTC enforcement actions (other than cease and desist requests) under this Act.

preserve access affordable generics act amends federal_trade_commission act authorize federal_trade_commission ftc initiate proceeding parties agreement resolving settling final interim basis patent infringement claim connection sale drug establishes presumption agreement anticompetitive effects unlawful filer abbreviated new drug generic application receives value agrees limit forego research development manufacturing marketing sales generic drug period time allows exception presumption parties agreement demonstrate clear convincing evidence based specified competitive factors pro competitive benefits agreement outweigh anticompetitive effects exempts restrictions act resolution settlement patent infringement claim consideration granted brand manufacturer generic manufacturer right market generic drug united_states prior expiration patent basis patent infringement claim patent right statutory exclusivity prevent marketing drug payment reasonable litigation expenses exceeding million covenant sue claim generic drug infringes patent allows review ftc enforcement orders act federal court imposes civil penalties violations act amends medicare_prescription_drug improvement modernization act require brand manufacturer generic manufacturer submit ftc agreements parties enter days entering agreement related manufacturing marketing sale brand generic drug exclusivity period requires chief executive officer company official responsible negotiating agreement file certification materials filed respect agreement complete final exclusive amends cosmetic act forfeit day exclusivity period marketing generic drug final decision ftc court agreement violated act grants ftc exclusive authority litigate matters relating anticompetitive practices connection sale generic brand drugs establishes year limitation period bringing ftc enforcement actions cease desist requests act


Summary: Medical Device Access and Innovation Protection Act - Amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers.

medical device access innovation protection act amends internal revenue code repeal excise tax medical device manufacturers importers


Summary:
Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2013 - Amends title II (Old Age, Survivors and Disability Benefits) (OASDI) of the Social Security Act (SSA) to extend the months of coverage of immunosuppressive drugs for kidney transplant patients.

Amends SSA title XVIII (Medicare) to make eligible for enrollment in Medicare part B (Supplementary Medical Insurance), solely for the purpose of such drug coverage, every individual whose insurance benefits under Medicare part A (Hospital Insurance) have ended by reason of a kidney transplant or the end of any requirement for a regular course of dialysis.

Directs the Secretary of Health and Human Services (HHS) to determine a monthly premium rate for such individuals equal to 35% of the monthly actuarial rate for enrollees age 65 and over. Prescribes a formula for detemination of a government contribution to such a premium.

comprehensive immunosuppressive drug coverage kidney transplant patients act amends title old age survivors disability benefits oasdi social security act ssa extend months coverage immunosuppressive drugs kidney transplant patients amends ssa title xviii medicare eligible enrollment medicare supplementary_medical_insurance solely purpose drug coverage individual insurance benefits medicare ended reason kidney transplant end requirement regular course dialysis directs secretary health_and_human_services hhs determine monthly premium rate individuals equal monthly actuarial rate enrollees age prescribes formula government contribution premium


Summary: Amends the Internal Revenue Code to add vaccines against seasonal influenza to the list of those vaccines subject to the excise tax on taxable vaccines.

amends internal revenue code add vaccines seasonal influenza list vaccines subject excise tax taxable vaccines


Summary:
Fair And Immediate Release of Generic Drugs Act or FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patent holder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant).

Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decided that the patent was invalid or not infringed; and (3) the applicant does not begin commercial marketing of such drug until 30 days after the first applicant began such commercial marketing.

Prohibits a party that enters an agreement to delay seeking approval of its generic drug application or to delay the commercial marketing of a generic drug from seeking approval of its application or beginning commercial marketing before the earlier of: (1) the latest date set forth in the agreement to seek approval or market the drug without regard to any earlier date under the agreement when commercial marketing could begin, or (2) 180 days after another first applicant begins commercial marketing of such drug.

Requires notice to the Secretary of the Health and Human Services (HHS) of the details of any agreement under this Act not later than ten business days after execution of the agreement.

Declares that the exclusive remedy for an infringement of a patent included within a new drug application shall be an action brought under the FFDCA within the 45-day period prescribed.

fair immediate release generic drugs act fair generics act amends cosmetic act ffdca revise definition applicant purposes day exclusivity period given applicants file abbreviated new drug application generic drug makes applicants generic drug eligible exclusivity period entered disqualifying agreement agreement generic drug applicant holder application listed drug brand drug patent holder brand drug generic drug applicant agrees seek approval generic drug begin commercial marketing generic drug expiration exclusivity period awarded generic applicant expands definition applicant include applicant meets following criteria applicant generic applicant action patent infringement brought action withdrawn dismissed court decision patent valid infringed court decided patent invalid infringed applicant begin commercial marketing drug days applicant began commercial marketing prohibits party enters agreement delay seeking approval generic drug application delay commercial marketing generic drug seeking approval application beginning commercial marketing earlier latest date set forth agreement seek approval market drug regard earlier date agreement commercial marketing begin days applicant begins commercial marketing drug requires notice secretary health_and_human_services hhs details agreement act later business days execution agreement declares exclusive remedy infringement patent included new drug application shall action brought ffdca day period prescribed


Summary:
Medical Innovation Prize Fund Act - Denies any person the exclusive right to manufacture, distribute, sell, or use in interstate commerce a drug, a biological product, or a drug or biological product manufacturing process, including the exclusive right to rely on health registration data or the 30-month stay-of-effectiveness period for Orange Book patents. Prescribes remuneration, in the form of prize payments from a Fund for Medical Innovation Prizes, in lieu of such market exclusivity.

Establishes: (1) the Fund for Medical Innovation Prizes; and (2) a Board of Trustees for such Fund, which shall award prize payments for medical innovation and establish independent expert advisory committees.

Directs the Board to award prize payments for medical innovation relating to a drug, a biological product, or a new manufacturing process for a drug or biological product to: (1) the first person to receive market clearance with respect to the drug or biological product; (2) the holder of the patent with respect to a manufacturing process; or (3) persons or communities that as an open source contribution openly shared knowledge, data, materials, and technology on a royalty-free and nondiscriminatory basis.

Requires the Board to establish and periodically modify minimum levels of funding for such awards for priority research and development, including global neglected diseases, orphan diseases, and global infectious diseases and other global public health priorities.

Allows the Board of Trustees to authorize multiple nonprofit intermediaries to reward projects for interim research and development of products or for open source dividend prizes.

Requires the Comptroller General (GAO) to conduct annual audits to determine the Board's effectiveness in bringing to market new drugs, vaccines, biological products, and manufacturing processes in a cost-effective manner and in addressing society's global medical needs.

Establishes an annual fee for health insurers to fund this Act.

medical innovation prize fund act denies person exclusive right manufacture distribute sell use interstate commerce drug biological product drug biological product manufacturing process including exclusive right rely health registration data month stay effectiveness period patents prescribes remuneration form prize payments lieu market exclusivity establishes fund medical innovation prizes board_of_trustees fund shall award prize payments medical innovation establish independent expert advisory committees directs board award prize payments medical innovation relating drug biological product new manufacturing process drug biological product person receive market clearance respect drug biological product holder patent respect manufacturing process persons communities open source contribution openly shared knowledge data materials technology royalty free nondiscriminatory basis requires board establish periodically modify minimum levels funding awards priority research development including global neglected diseases orphan diseases global infectious diseases global public health priorities authorize multiple nonprofit intermediaries reward projects interim research development products open source dividend prizes requires comptroller general gao conduct annual audits determine board effectiveness bringing market new drugs vaccines biological products manufacturing processes cost effective manner addressing society global medical needs establishes annual fee health insurers fund act


Summary:
Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to promulgate regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (PMI) for prescription drugs.

Requires such regulations to require the PMI for such a drug: (1) to be scientifically accurate and to be based on the approved professional labeling and authoritative, peer-reviewed literature; and (2) to include plain language that is not promotional in tone or content. Requires that such language include: (1) the established name of the drug; (2) drug uses and clinical benefits; (3) general directions for proper use; (4) contraindications, common side effects, and the most serious risks of the drug; (5) measures patients may take to reduce the side effects and risks; (6) when a patient should contact his or her health care professional; (7) instructions not to share medications; (8) any key storage requirements; (9) recommendations relating to proper disposal of any unused portion of the drug; and (10) known clinically important interactions with other drugs and substances.

Requires such regulations to: (1) include standards related to performing timely updates of drug information, ensuring that common information is applied consistently and simultaneously across similar drug products and for drugs within classes of medications, and developing a process to assess the quality and effectiveness of PMI in promoting patient understanding and safe and effective use; and (2) provide for the development of a publicly accessible electronic repository for all PMI.

Requires the Secretary to publish on the Food and Drug Administration (FDA) website a link to the Daily Med website.

safer prescriptions act amends cosmetic act direct secretary health_and_human_services hhs promulgate regulations authorship content format dissemination requirements patient medication information prescription drugs requires regulations require drug scientifically accurate based approved professional labeling authoritative peer reviewed literature include plain language promotional tone content requires language include established drug drug uses clinical benefits general directions proper use contraindications common effects risks drug measures patients reduce effects risks patient contact health care professional instructions share medications key storage requirements recommendations relating proper disposal unused portion drug known clinically important interactions drugs substances requires regulations include standards related performing timely updates drug information ensuring common information applied consistently simultaneously similar drug products drugs classes medications developing process assess quality effectiveness promoting patient understanding safe effective use provide development publicly accessible electronic repository requires secretary publish food_and_drug_administration fda website link website


Summary: Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to exclude from the average sales price in calculating Medicare payments for drugs and biologicals any customary prompt pay discounts from manufacturers to wholesalers

amends supplementary_medical_insurance title xviii medicare social security act exclude average sales price calculating medicare payments drugs biologicals customary prompt pay discounts manufacturers wholesalers


Summary:
Antimicrobial Data Collection Act - Requires the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs (FDA), to develop a research program to study the relationship between the sales, distribution, and end-use practices of animal drugs containing an antimicrobial active ingredient in food-producing animals and antimicrobial resistance trends. Requires the Secretary to analyze data from the program to determine the data's contribution to studying antimicrobial resistance and establishing an antimicrobial data collection strategy.

Requires the Secretary to: (1) report to Congress on the program's research design and goals, including a needs assessment to improve the FDA's evaluation of antimicrobial resistance; and (2) report to Congress and the public within two years with the comprehensive results of the program and recommendations for developing an antimicrobial data collection strategy.

Amends the Federal Food, Drug, and Cosmetic Act to revise the requirements for the annual summaries of antimicrobial animal drug information, including by requiring the Secretary to maximize the quality, accuracy, detail, and specificity of the data made publicly available in the summaries. Requires the Secretary to conduct an annual evaluation of the effectiveness of and compliance with relevant FDA programs and policies regarding antimicrobial drug sales for food-producing animals, and the use of such drugs and antimicrobial resistance.

Directs the Secretary to publish a final version of voluntary guidance for drug sponsors on new animal drugs and new animal drug combination products administered in or on medicated feed or drinking water of food-producing animals.

Requires the Comptroller General (GAO) to evaluate the FDA's approaches to eliminate injudicious use of antimicrobial drugs in food-producing animals and the effectiveness of the FDA's data collection activities regarding antimicrobial resistance.

secretary health_and_human_services hhs acting commissioner food drugs fda develop research program study relationship sales distribution end use practices animal drugs containing antimicrobial active ingredient food producing animals antimicrobial resistance trends requires secretary analyze data program determine data contribution studying antimicrobial resistance establishing antimicrobial data collection strategy requires secretary report congress program research design goals including needs assessment improve fda evaluation antimicrobial resistance report congress public years comprehensive results program recommendations developing antimicrobial data collection strategy amends cosmetic act revise requirements annual summaries antimicrobial animal drug information including requiring secretary maximize quality accuracy detail specificity data publicly available summaries requires secretary conduct annual evaluation effectiveness compliance relevant fda programs policies antimicrobial drug sales food producing animals use drugs antimicrobial resistance directs secretary publish final version voluntary guidance drug sponsors new animal drugs new animal drug combination products administered feed drinking water food producing animals requires comptroller general gao evaluate fda approaches eliminate use antimicrobial drugs food producing animals effectiveness fda data collection activities antimicrobial resistance


Summary: Amends title XVIII (Medicare) of the Social Security Act to authorize direct payment under part B (Supplementary Medical Insurance Benefits for the Aged and Disabled) to a pharmacy for certain covered compound drugs prepared by the pharmacy for a specific beneficiary for the effective use of an implanted infusion pump.

amends title xviii medicare social security act authorize direct payment supplementary medical insurance benefits aged disabled pharmacy certain covered compound drugs prepared pharmacy specific beneficiary effective use implanted infusion pump


Summary:
Drug Supply Chain Security Act - Amends the Federal Food, Drug, and Cosmetic Act to establish requirements to facilitate the tracing of drug products through the pharmaceutical supply distribution chain.

Provides requirements of standards for the exchange of transaction documentation, to be established by the Secretary.

Requires the Secretary to establish processes to: (1) provide waivers of requirements, including for undue economic hardship or emergency medical reasons; (2) provide exceptions to requirements relating to product identifiers if a product is packaged without sufficient space to bear the information; and (3) determine other products or transactions that should be exempt from the requirements of this section.

 Permits certain requirements of this Act applicable to manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers to be enforced without further regulations or guidance from the Secretary.

 Requires the Secretary to finalize guidance within two years specifying whether and under what circumstances a product that is not labeled with a product identifier, and that is in the pharmaceutical distribution supply chain when applicable requirements go into effect, shall be exempted from such requirements. Exempts products that entered the pharmaceutical distribution supply chain before the date that is one year after enactment of this Act from requirements related to transaction documentation.

 Requires drug manufacturers to provide transaction documentation before, or at the time of, each transfer of ownership of a product or transfer of possession to a third-party logistics provider for subsequent transfer of ownership.

 Requires a wholesale distributor, dispenser, or repackager to provide to the subsequent purchaser transaction documentation for the product.

Prohibits a wholesale distributor, dispenser, or repackager from accepting ownership of a product unless the previous owner before, or at the time of, the transaction provides such transaction documentation. Prohibits a third-party logistics provider from accepting possession of a product unless such documentation is provided.

Requires the manufacturer, wholesale distributor, dispenser, repackager, or third-party logistics provider to maintain the transaction documentation for each transaction (or, for a third-party logistics provider, each transfer of possession) for at least six years.

Requires a manufacturer, wholesale distributor, dispenser, repackager, or third-party logistics provider, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, to provide within 24 hours (or, for a dispenser, within two business days), or in such other reasonable time as determined by the Secretary, the applicable transaction documentation upon request by the Secretary or other appropriate federal or state official.

 Requires a manufacturer within four years (for repackagers, within five years) to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce. Requires a manufacturer and repackager to maintain product identifier information for at least six years from the date of transaction.

Allows a wholesale distributor, dispenser, repackager, or third-party logistics provider to engage in transactions involving a product, or accept possession of a product, only if the product has a product identifier. Sets the effective date of this requirement for repackagers at five years after enactment, with later effective dates for the other entities.

Requires the trading partners of a manufacturer, wholesale distributor, dispenser, repackager, or third-party logistics provider to be authorized trading partners (i.e., properly registered or licensed by the state).

Requires a manufacturer, wholesale distributor, dispenser, repackager, or third-party logistics provider to have systems in place to: (1) quarantine a suspect product; (2) promptly conduct an investigation to determine whether the product is an illegitimate product or, for a third-party logistics provider, notify the owner of the need to conduct such an investigation; and (3) for manufacturers, beginning four years after enactment, verify the product at the package level, including the standardized numerical identifier. Requires entities to maintain records of such activities for six years.

Requires a manufacturer, wholesale distributor, dispenser, or repackager, upon a determination that a product in its possession or control is an illegitimate product, to: (1) quarantine the product (except that this does not apply to dispensers), (2) remove the product from the pharmaceutical distribution supply chain, (3) take reasonable and appropriate steps to assist a trading partner to remove such product from the supply chain, (4) retain a sample of the product for further physical examination or laboratory analysis, and (5) notify the Secretary and all immediate trading partners within 24 hours. Requires a third-party logistics provider, upon such a determination, to promptly notify the owner of the need to remove the product from the pharmaceutical distribution supply chain, promptly transfer possession of the product to the owner, and notify the Secretary within 24 hours.

Requires a manufacturer to notify the Secretary and immediate trading partners within 24 hours if the manufacturer has reason to believe that there is a high risk that a product in the trading partner’s possession is an illegitimate product.

Requires a manufacturer or repackager to respond within 24 hours or in other reasonable time as determined by the Secretary after receiving a verification request from an authorized repackager, wholesale distributor, or dispenser whether the product identifier corresponds to the product identifier it affixed or imprinted.

Requires the manufacturer, wholesale distributor, or repackager to verify the product identifier of a returned product that it intends to further distribute.

Allows the wholesale distributor to accept a returned product from a dispenser and distribute it without the transaction history for the next six years. Permits a wholesale distributor, beginning six years after enactment, to accept a returned product from a dispenser only if the wholesale distributor can associate the returned product with the transaction information and transaction statement associated with that product.

Allows a dispenser or repackager to return a product to the trading partner from which the dispenser purchased the product without providing the transaction documentation.

Authorizes a dispenser to enter into an agreement under which a third party confidentially maintains transaction documentation on the dispenser's behalf.

Exempts a wholesale distributor that does not physically handle or store products from the provisions of this Act, except the notification requirements related to illegitimate products, provided the transaction documentation is given to the dispenser by the manufacturer, repackager, or other wholesale distributor that distributes the product.

Establishes package level requirements for the interoperable, electronic tracing of products that shall go into effect 10 years after enactment of this Act.

Requires the Secretary to provide alternative methods of compliance with such requirements, including establishing a time line for compliance by small businesses.

Directs the Secretary to enter into a contract with a consulting firm to conduct a technology and software assessment that looks at the feasibility of dispensers conducting interoperable, electronic tracing of products at the package level.

Sets forth guidance documents to be issued by the Secretary related to suspect and illegitimate products, secure tracing at the package level, and the interoperable standards necessary to enhance the security of the pharmaceutical distribution supply chain.

Requires the Secretary to establish pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.

Requires wholesale distributors operating in a state without licensure requirements to be licensed by the Secretary. Requires wholesale distributors to be licensed by the state into which the drug is distributed if the state requires it.

Establishes annual reporting requirements for wholesale distributors. Requires the Secretary to establish a database of licensed wholesale distributors. Authorizes the Secretary to collect fees for licensure.

Requires third-party logistics providers to obtain a license from the Secretary, but not a license as a wholesale distributor if the entity never assumes an ownership interest in the products it handles.

Requires the Secretary to establish minimum standards, terms, and conditions for the state or federal licensing of wholesale distributors. Lists the requirements for such minimum standards.

Prohibits a third-party logistics provider in any state from conducting activities unless each facility of the provider is: (1) licensed by the state from which the drug is distributed by the provider and the state into which the drug is distributed, or (2) licensed by the Secretary if the state has not established a licensure requirement. Establishes annual reporting requirements for the facilities of a third-party logistics provider. Authorizes the Secretary to assess licensure fees. Requires the Secretary to establish minimum requirements for the licensure of third-party logistics providers.

Preempts state or local government requirements for tracing products through the distribution system which are inconsistent with, more stringent than, or in addition to, any requirements under this Act, or which are inconsistent with any waiver, exception, exemption, or restriction under this Act.

Prohibits any state or or local government from establishing or continuing any standards, requirements, or regulations with respect to the licensing of wholesale prescription drug distributors or third-party logistics providers that are less stringent than the standards under this Act. Prohibits a state from regulating a third-party logistics providers as a wholesale distributor.

Deems a drug to be misbranded if it does not contain a product identifier as required by this Act.

drug supply chain security act amends cosmetic act establish requirements facilitate tracing drug products pharmaceutical supply distribution chain provides requirements standards exchange transaction documentation established secretary requires secretary establish processes provide waivers requirements including undue economic hardship emergency medical reasons provide exceptions requirements relating product identifiers product packaged sufficient space bear information determine products transactions exempt requirements section permits certain requirements act applicable manufacturers wholesale distributors party logistics providers dispensers enforced regulations guidance secretary requires secretary finalize guidance years specifying circumstances product labeled product identifier pharmaceutical distribution supply chain applicable requirements effect shall exempted requirements exempts products entered pharmaceutical distribution supply chain date year enactment act requirements related transaction documentation requires drug manufacturers provide transaction documentation time transfer ownership product transfer possession party logistics provider subsequent transfer ownership requires wholesale distributor dispenser repackager provide subsequent purchaser transaction documentation product prohibits wholesale distributor dispenser repackager accepting ownership product previous owner time transaction provides transaction documentation prohibits party logistics provider accepting possession product documentation provided requires manufacturer wholesale distributor dispenser repackager party logistics provider maintain transaction documentation transaction party logistics provider transfer possession years requires manufacturer wholesale distributor dispenser repackager party logistics provider event recall purpose investigating suspect product illegitimate product provide hours dispenser business days reasonable time determined secretary applicable transaction documentation request secretary appropriate federal state official requires manufacturer years years affix product identifier package case product intended introduced transaction commerce requires manufacturer repackager maintain product identifier information years date transaction allows wholesale distributor dispenser repackager party logistics provider engage transactions involving product accept possession product product product identifier sets effective date requirement years enactment later effective dates entities requires trading partners manufacturer wholesale distributor dispenser repackager party logistics provider authorized trading partners properly registered licensed state requires manufacturer wholesale distributor dispenser repackager party logistics provider systems place quarantine suspect product promptly conduct investigation determine product illegitimate product party logistics provider notify owner need conduct investigation manufacturers beginning years enactment verify product package level including standardized numerical identifier requires entities maintain records activities years requires manufacturer wholesale distributor dispenser repackager determination product possession control illegitimate product quarantine product apply dispensers remove product pharmaceutical distribution supply chain reasonable appropriate steps assist trading partner remove product supply chain retain sample product physical examination laboratory analysis notify secretary immediate trading partners hours requires party logistics provider determination promptly notify owner need remove product pharmaceutical distribution supply chain promptly transfer possession product owner notify secretary hours requires manufacturer notify secretary immediate trading partners hours manufacturer reason believe high risk product trading partner possession illegitimate product requires manufacturer repackager respond hours reasonable time determined secretary receiving verification request authorized repackager wholesale distributor dispenser product identifier corresponds product identifier affixed requires manufacturer wholesale distributor repackager verify product identifier returned product intends distribute allows wholesale distributor accept returned product dispenser distribute transaction history years permits wholesale distributor beginning years enactment accept returned product dispenser wholesale distributor associate returned product transaction information transaction statement associated product allows dispenser repackager return product trading partner dispenser purchased product providing transaction documentation authorizes dispenser enter agreement party confidentially maintains transaction documentation dispenser behalf exempts wholesale distributor physically handle store products provisions act notification requirements related illegitimate products provided transaction documentation given dispenser manufacturer repackager wholesale distributor distributes product establishes package level requirements interoperable electronic tracing products shall effect years enactment act requires secretary provide alternative methods compliance requirements including establishing time line compliance small businesses directs secretary enter contract consulting firm conduct technology software assessment feasibility dispensers conducting interoperable electronic tracing products package level sets forth guidance documents issued secretary related suspect illegitimate products secure tracing package level interoperable standards necessary enhance security pharmaceutical distribution supply chain requires secretary establish pilot projects explore evaluate methods enhance safety security pharmaceutical distribution supply chain requires wholesale distributors operating state licensure requirements licensed secretary requires wholesale distributors licensed state drug distributed state requires establishes annual reporting requirements wholesale distributors requires secretary establish database licensed wholesale distributors authorizes secretary collect fees licensure requires party logistics providers obtain license secretary license wholesale distributor entity assumes ownership interest products handles requires secretary establish minimum standards terms conditions state federal licensing wholesale distributors lists requirements minimum standards prohibits party logistics provider state conducting activities facility provider licensed state drug distributed provider state drug distributed licensed secretary state established licensure requirement establishes annual reporting requirements facilities party logistics provider authorizes secretary assess licensure fees requires secretary establish minimum requirements licensure party logistics providers preempts state local government requirements tracing products distribution system inconsistent stringent addition requirements act inconsistent waiver exception exemption restriction act prohibits state local government establishing continuing standards requirements regulations respect licensing wholesale prescription drug distributors party logistics providers stringent standards act prohibits state regulating party logistics providers wholesale distributor deems drug misbranded contain product identifier required act


Summary:
Pharmaceutical Quality, Security, and Accountability Act - Title I: Human Drug Compounding - Pharmaceutical Compounding Quality and Accountability Act - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the regulation of compounded drugs.

 Subjects a compounded drug to all FFDCA requirements applicable to new drugs. Sets forth exceptions from new drug requirements, biological product requirements, labeling requirements, and good manufacturing practice requirements for a drug that: (1) is compounded by a traditional compounder, and (2) meets applicable requirements.

Defines “traditional compounder” as a facility operating pursuant to state law that meets certain criteria, including that a drug is compounded by a licensed pharmacist or licensed physician pursuant to a prescription order for an identified individual patient or compounded in limited qualities before a prescription order based on history of receiving such prescription orders. Includes as a traditional compounder hospitals and health systems (collection of hospitals) that compound drugs only to dispense or administer them to patients of the hospital or health system.

 Exempts from labeling requirements, new drug requirements and biological product requirements a compounded prescription drug that: (1) is compounded by a compounding manufacturer that is not licensed as a pharmacy in any state but is in compliance with this Act, and (2) meets the applicable requirements for drugs compounded by a compounding manufacturer.

Defines “compounding manufacturer” as a facility at one geographic location or address that: (1) compounds any sterile drug without receiving a prescription order for an identified individual patient before beginning compounding, and distributes or offers to sell such compounded sterile drug in interstate commerce; or (2) repackages any preservative-free sterile drug or engages in sterile pooling. Excludes from such definition a compounding nuclear pharmacy or a hospital or health system that repackages a drug because of a drug shortage and does not otherwise meet the definition of compounding manufacturer.

 Sets forth a list of drugs that may not be compounded, which includes:

 any drug that presents demonstrable difficulties for compounding, as designated by the Secretary of Health and Human Services (HHS); a drug that is a copy of a marketed new drug or a variation of such drug compounded from bulk drug substances, unless it is on the drug shortage list or is a variation for an individually identified patient that produces a clinical difference for a patient; a new drug or biological product subject to an approved risk evaluation and mitigation strategy (REMS) with elements to assure safe use, unless the compounder receives a prescription order for an identified individual patient and demonstrates before compounding that the entity will utilize controls comparable to the REMS for the drug or product; and drugs that have been withdrawn or removed from the market because they have been found to be unsafe or not effective. Prohibits the compounding of biological products unless the compounded variation: (1) is compounded solely using a licensed biological product or solely using such a product and one or more ingredients in compliance with established standards for medicines and pharmaceuticals, (2) produces for the patient a clinical difference, (3) is produced for an individually identified patient with a prescription or for an identified patient or patients pursuant to a duly authorized medical order from a health care entity, or (4) is a radioactive biological product that is compounded by a nuclear pharmacy. Permits a traditional compounder to begin compounding a variation on a licensed biological product before receiving a prescription order if it is for emergency use in pediatric patients and produces a clinical difference for the patient.

Prohibits the compounding of an allergenic product that is a variation of a licensed biological product unless the compounded variation is compounded solely using one or more licensed allergenic products and one or more ingredients in compliance with established standards for medicines and pharmaceuticals. Establishes standards for the bulk drug substances or ingredients used to compound a drug or product, including that such substances or ingredients must: (1) comply with established standards for medicines and pharmaceuticals, (2) use substances manufactured by registered establishments, (3) be accompanied by valid certificates of analysis for each specific lot of substance, and (4) comply with established pharmacy compounding standards.

 Authorizes the Secretary to identify bulk substances that may not be used in compounding a drug because of public health concerns.

Prohibits a compounded drug from being sold by an entity other than the one that compounded it.

 Allows a compounding manufacturer to sell or transfer a compounded drug to: (1) a health care entity that provides medical services through licensed practitioners directly to patients, or (2) a licensed pharmacy without profit under certain circumstances.

 Requires a compounded drug offered for sale to be labeled as “not for resale.”

 Requires a compounding manufacturer to ensure that a licensed pharmacist in the state where the compounding manufacturer is located exercises direct supervision over its operations.

Establishes requirements for a compounding manufacturer to include: (1) annual registration, (2) biannual reporting on the drugs it compounds, (3) reporting of serious adverse events associated with the use of a compounded drug, and (4) labeling of compounded drugs. Subjects compounding manufacturers to inspection of their facilities according to a risk-based schedule.

 Directs the Secretary to assess an annual establishment fee on each compounding manufacturer and a reinspection fee from each compounding manufacturer subject to a reinspection in a fiscal year.

 Directs the Secretary to encourage states to identify any state-licensed pharmacies that appear to be compounding manufacturers required to register with the Secretary.

Requires the Comptroller General to study the safety of animal drug compounding and the availability of safe and effective drugs for animals.

(Sec. 103) Deems a compounded drug to be misbranded if: (1) the labeling does not include the required information established under this Act, (2) the advertising or promotion of a compounded drug is false or misleading in any particular, or (3) the compounding manufacturer did not pay required fees.

(Sec. 104) Requires the Secretary to consult with relevant stakeholders in implementing this Act. Requires the Secretary, in promulgating any implementing regulations, to issue a notice of proposed rulemaking that includes the proposed regulation, provide a period of at least 60 calendar days for comments, and publish the final regulation within 18 months and at least 30 calendar days before the effective date of the final regulation.

(Sec. 105) Makes this title effective one year after enactment.

 Title II: Drug Supply Chain Security - Drug Supply Chain Security Act - (Sec. 202) Amends the Federal Food, Drug, and Cosmetic Act to establish requirements to facilitate the tracing of drug products through the pharmaceutical supply distribution chain.

 Requires the Secretary to establish standards for the exchange of transaction documentation that consists of:

 transaction information, which is the name of the product, its strength and dosage form, its National Drug Code number, the number and size of its containers, its lot number, the date of the transaction, the shipment date, the business name and address of the person from whom ownership is being transferred, and the business name and address of the person to whom ownership is being transferred; transaction history, which is a statement that includes the transaction information for each prior transaction going back to the manufacturer; and a transaction statement, which is a statement that the entity transferring ownership is authorized, received the product from a person that also is authorized (i.e., properly registered or licensed by the state), received transaction documentation from the prior owner, did not knowingly ship a suspect or illegitimate product, had systems and processes in place to comply with verification requirements under this Act, did not knowingly provide false transaction information, and did not knowingly alter the transaction history. Requires the Secretary to establish processes to: (1) provide waivers of requirements, including for undue economic hardship or emergency medical reasons; (2) provide exceptions to requirements relating to product identifiers if a product is packaged without sufficient space to bear the information; and (3) determine other products or transactions that should be exempt from the requirements of this section.

 Permits certain requirements of this Act applicable to manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers to be enforced without further regulations or guidance from the Secretary.

 Requires the Secretary to finalize guidance within two years specifying whether and under what circumstances a product that is not labeled with a product identifier, and that is in the pharmaceutical distribution supply chain when applicable requirements go into effect, shall be exempted from such requirements. Exempts products that entered the pharmaceutical distribution supply chain before the date that is one year after enactment of this Act from requirements related to transaction documentation.

 Requires drug manufacturers to provide transaction documentation before, or at the time of, each transfer of ownership of a product or transfer of possession to a third-party logistics provider for subsequent transfer of ownership.

 Requires a wholesale distributor, dispenser, or repackager to provide to the subsequent purchaser transaction documentation for the product.

Prohibits a wholesale distributor, dispenser, or repackager from accepting ownership of a product unless the previous owner before, or at the time of, the transaction provides such transaction documentation. Prohibits a third-party logistics provider from accepting possession of a product unless such documentation is provided.

Requires the manufacturer, wholesale distributor, dispenser, repackager, or third-party logistics provider to maintain the transaction documentation for each transaction (or, for a third-party logistics provider, each transfer of possession) for at least six years.

Requires a manufacturer, wholesale distributor, dispenser, repackager, or third-party logistics provider, in the event of a recall or for the purpose of investigating a suspect product or an illegitimate product, to provide within 24 hours (or, for a dispenser, within two business days), or in such other reasonable time as determined by the Secretary, the applicable transaction documentation upon request by the Secretary or other appropriate federal or state official.

 Requires a manufacturer within four years (for repackagers, within five years) to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce. Requires a manufacturer and repackager to maintain product identifier information for at least six years from the date of transaction.

Allows a wholesale distributor, dispenser, repackager, or third-party logistics provider to engage in transactions involving a product, or accept possession of a product, only if the product has a product identifier. Sets the effective date of this requirement for repackagers at five years after enactment, with later effective dates for the other entities.

Requires the trading partners of a manufacturer, wholesale distributor, dispenser, repackager, or third-party logistics provider to be authorized trading partners (i.e., properly registered or licensed by the state).

Requires a manufacturer, wholesale distributor, dispenser, repackager, or third-party logistics provider to have systems in place to: (1) quarantine a suspect product; (2) promptly conduct an investigation to determine whether the product is an illegitimate product or, for a third-party logistics provider, notify the owner of the need to conduct such an investigation; and (3) for manufacturers, beginning four years after enactment, verify the product at the package level, including the standardized numerical identifier. Requires entities to maintain records of such activities for six years.

Requires a manufacturer, wholesale distributor, dispenser, or repackager, upon a determination that a product in its possession or control is an illegitimate product, to: (1) quarantine the product (except that this does not apply to dispensers), (2) remove the product from the pharmaceutical distribution supply chain, (3) take reasonable and appropriate steps to assist a trading partner to remove such product from the supply chain, (4) retain a sample of the product for further physical examination or laboratory analysis, and (5) notify the Secretary and all immediate trading partners within 24 hours. Requires a third-party logistics provider, upon such a determination, to promptly notify the owner of the need to remove the product from the pharmaceutical distribution supply chain, promptly transfer possession of the product to the owner, and notify the Secretary within 24 hours.

Requires a manufacturer to notify the Secretary and immediate trading partners within 24 hours if the manufacturer has reason to believe that there is a high risk that a product in the trading partner’s possession is an illegitimate product.

Requires a manufacturer or repackager to respond within 24 hours or in other reasonable time as determined by the Secretary after receiving a verification request from an authorized repackager, wholesale distributor, or dispenser whether the product identifier corresponds to the product identifier it affixed or imprinted.

Requires the manufacturer, wholesale distributor, or repackager to verify the product identifier of a returned product that it intends to further distribute.

Allows the wholesale distributor to accept a returned product from a dispenser and distribute it without the transaction history for the next six years. Permits a wholesale distributor, beginning six years after enactment, to accept a returned product from a dispenser only if the wholesale distributor can associate the returned product with the transaction information and transaction statement associated with that product.

Allows a dispenser or repackager to return a product to the trading partner from which the dispenser purchased the product without providing the transaction documentation.

Authorizes a dispenser to enter into an agreement under which a third party confidentially maintains transaction documentation on the dispenser's behalf.

Exempts a wholesale distributor that does not physically handle or store products from the provisions of this Act, except the notification requirements related to illegitimate products, provided the transaction documentation is given to the dispenser by the manufacturer, repackager, or other wholesale distributor that distributes the product.

(Sec. 203) Establishes package level requirements for the interoperable, electronic tracing of products that shall go into effect ten years after enactment of this Act, including those relating to:

 exchange of transaction information and the transaction statements in a secure, interoperable, electronic manner; inclusion of the product identifier at the package level in the transaction information; systems and processes for verification of product at the package level; and systems and processes for promptly responding to requests for transaction documentation in the event of a recall or for the purposes of investigating a suspect product or an illegitimate product. Requires the Secretary to provide alternative methods of compliance with such requirements, including establishing a time line for compliance by small businesses.

Directs the Secretary to enter into a contract with a consulting firm to conduct a technology and software assessment that looks at the feasibility of dispensers conducting interoperable, electronic tracing of products at the package level.

Sets forth guidance documents to be issued by the Secretary related to suspect and illegitimate products, secure tracing at the package level, and the interoperable standards necessary to enhance the security of the pharmaceutical distribution supply chain.

Requires the Secretary to establish pilot projects to explore and evaluate methods to enhance the safety and security of the pharmaceutical distribution supply chain.

(Sec. 204) Requires wholesale distributors operating in a state without licensure requirements to be licensed by the Secretary. Requires wholesale distributors to be licensed by the state into which the drug is distributed if the state requires it.

Establishes annual reporting requirements for wholesale distributors. Requires the Secretary to establish a database of licensed wholesale distributors. Authorizes the Secretary to collect fees for licensure.

Requires third-party logistics providers to obtain a license from the Secretary, but not a license as a wholesale distributor if the entity never assumes an ownership interest in the products it handles.

Requires the Secretary to establish minimum standards, terms, and conditions for the state or federal licensing of wholesale distributors. Lists the requirements for such minimum standards.

(Sec. 205) Prohibits a third-party logistics provider in any state from conducting activities unless each facility of the provider is: (1) licensed by the state from which the drug is distributed by the provider and the state into which the drug is distributed, or (2) licensed by the Secretary if the state has not established a licensure requirement. Establishes annual reporting requirements for the facilities of a third-party logistics provider. Authorizes the Secretary to assess licensure fees. Requires the Secretary to establish minimum requirements for the licensure of third-party logistics providers.

Preempts state or local government requirements for tracing products through the distribution system which are inconsistent with, more stringent than, or in addition to, any requirements under this Act, or which are inconsistent with any waiver, exception, exemption, or restriction under this Act.

Prohibits any state or or local government from establishing or continuing any standards, requirements, or regulations with respect to the licensing of wholesale prescription drug distributors or third-party logistics providers that are less stringent than the standards under this Act. Prohibits a state from regulating a third-party logistics providers as a wholesale distributor.

(Sec. 206) Deems a drug to be misbranded if it does not contain a product identifier as required by this Act.

pharmaceutical quality security human drug compounding pharmaceutical compounding quality accountability act sec amends cosmetic act ffdca expand regulation compounded drugs subjects compounded drug ffdca requirements applicable new drugs sets forth exceptions new drug requirements biological product requirements labeling requirements good manufacturing practice requirements drug compounded traditional meets applicable requirements defines traditional facility operating pursuant state law meets certain criteria including drug compounded licensed pharmacist licensed physician pursuant prescription order identified individual patient compounded limited qualities prescription order based history receiving prescription orders includes traditional hospitals health systems collection hospitals compound drugs dispense administer patients hospital health system exempts labeling requirements new drug requirements biological product requirements compounded prescription drug compounded compounding manufacturer licensed pharmacy state compliance act meets applicable requirements drugs compounded compounding manufacturer defines compounding manufacturer facility geographic location address compounds sterile drug receiving prescription order identified individual patient beginning compounding distributes offers sell compounded sterile drug interstate commerce free sterile drug engages sterile pooling excludes definition compounding nuclear pharmacy hospital health system drug drug shortage meet definition compounding manufacturer sets forth list drugs compounded includes drug presents demonstrable difficulties compounding designated secretary health_and_human_services hhs drug copy marketed new drug variation drug compounded bulk drug substances drug shortage list variation individually identified patient produces clinical difference patient new drug biological product subject approved risk evaluation mitigation strategy elements assure safe use receives prescription order identified individual patient demonstrates compounding entity utilize controls comparable drug product drugs withdrawn removed market found unsafe effective prohibits compounding biological products compounded variation compounded solely licensed biological product solely product ingredients compliance established standards medicines pharmaceuticals produces patient clinical difference produced individually identified patient prescription identified patient patients pursuant duly authorized medical order health care entity radioactive biological product compounded nuclear pharmacy permits traditional begin compounding variation licensed biological product receiving prescription order emergency use pediatric patients produces clinical difference patient prohibits compounding product variation licensed biological product compounded variation compounded solely licensed products ingredients compliance established standards medicines pharmaceuticals establishes standards bulk drug substances ingredients compound drug product including substances ingredients comply established standards medicines pharmaceuticals use substances manufactured registered establishments accompanied valid certificates analysis specific lot substance comply established pharmacy compounding standards authorizes secretary identify bulk substances compounding drug public health concerns prohibits compounded drug sold entity compounded allows compounding manufacturer sell transfer compounded drug health care entity provides medical services licensed practitioners directly patients licensed pharmacy profit certain circumstances requires compounded drug offered sale labeled resale requires compounding manufacturer ensure licensed pharmacist state compounding manufacturer located exercises direct supervision operations establishes requirements compounding manufacturer include annual registration biannual reporting drugs compounds reporting adverse events associated use compounded drug labeling compounded drugs subjects compounding manufacturers inspection facilities according risk based schedule directs secretary assess annual establishment fee compounding manufacturer reinspection fee compounding manufacturer subject reinspection fiscal year directs secretary encourage states identify state licensed pharmacies appear compounding manufacturers required register secretary requires comptroller general study safety animal drug compounding availability safe effective drugs animals sec deems compounded drug misbranded labeling include required information established act advertising promotion compounded drug false misleading particular compounding manufacturer pay required fees sec requires secretary consult relevant stakeholders implementing act requires secretary promulgating implementing regulations issue notice proposed rulemaking includes proposed regulation provide period calendar days comments publish final regulation months calendar days effective date final regulation sec makes title effective year enactment title drug supply chain security drug supply chain security act sec amends cosmetic act establish requirements facilitate tracing drug products pharmaceutical supply distribution chain requires secretary establish standards exchange transaction documentation consists transaction information product strength dosage form number number size containers lot number date transaction shipment date business address person ownership transferred business address person ownership transferred transaction history statement includes transaction information prior transaction going manufacturer transaction statement statement entity transferring ownership authorized received product person authorized properly registered licensed state received transaction documentation prior owner knowingly ship suspect illegitimate product systems processes place comply verification requirements act knowingly provide false transaction information knowingly alter transaction history requires secretary establish processes provide waivers requirements including undue economic hardship emergency medical reasons provide exceptions requirements relating product identifiers product packaged sufficient space bear information determine products transactions exempt requirements section permits certain requirements act applicable manufacturers wholesale distributors party logistics providers dispensers enforced regulations guidance secretary requires secretary finalize guidance years specifying circumstances product labeled product identifier pharmaceutical distribution supply chain applicable requirements effect shall exempted requirements exempts products entered pharmaceutical distribution supply chain date year enactment act requirements related transaction documentation requires drug manufacturers provide transaction documentation time transfer ownership product transfer possession party logistics provider subsequent transfer ownership requires wholesale distributor dispenser repackager provide subsequent purchaser transaction documentation product prohibits wholesale distributor dispenser repackager accepting ownership product previous owner time transaction provides transaction documentation prohibits party logistics provider accepting possession product documentation provided requires manufacturer wholesale distributor dispenser repackager party logistics provider maintain transaction documentation transaction party logistics provider transfer possession years requires manufacturer wholesale distributor dispenser repackager party logistics provider event recall purpose investigating suspect product illegitimate product provide hours dispenser business days reasonable time determined secretary applicable transaction documentation request secretary appropriate federal state official requires manufacturer years years affix product identifier package case product intended introduced transaction commerce requires manufacturer repackager maintain product identifier information years date transaction allows wholesale distributor dispenser repackager party logistics provider engage transactions involving product accept possession product product product identifier sets effective date requirement years enactment later effective dates entities requires trading partners manufacturer wholesale distributor dispenser repackager party logistics provider authorized trading partners properly registered licensed state requires manufacturer wholesale distributor dispenser repackager party logistics provider systems place quarantine suspect product promptly conduct investigation determine product illegitimate product party logistics provider notify owner need conduct investigation manufacturers beginning years enactment verify product package level including standardized numerical identifier requires entities maintain records activities years requires manufacturer wholesale distributor dispenser repackager determination product possession control illegitimate product quarantine product apply dispensers remove product pharmaceutical distribution supply chain reasonable appropriate steps assist trading partner remove product supply chain retain sample product physical examination laboratory analysis notify secretary immediate trading partners hours requires party logistics provider determination promptly notify owner need remove product pharmaceutical distribution supply chain promptly transfer possession product owner notify secretary hours requires manufacturer notify secretary immediate trading partners hours manufacturer reason believe high risk product trading partner possession illegitimate product requires manufacturer repackager respond hours reasonable time determined secretary receiving verification request authorized repackager wholesale distributor dispenser product identifier corresponds product identifier affixed requires manufacturer wholesale distributor repackager verify product identifier returned product intends distribute allows wholesale distributor accept returned product dispenser distribute transaction history years permits wholesale distributor beginning years enactment accept returned product dispenser wholesale distributor associate returned product transaction information transaction statement associated product allows dispenser repackager return product trading partner dispenser purchased product providing transaction documentation authorizes dispenser enter agreement party confidentially maintains transaction documentation dispenser behalf exempts wholesale distributor physically handle store products provisions act notification requirements related illegitimate products provided transaction documentation given dispenser manufacturer repackager wholesale distributor distributes product sec establishes package level requirements interoperable electronic tracing products shall effect years enactment act including relating exchange transaction information transaction statements secure interoperable electronic manner inclusion product identifier package level transaction information systems processes verification product package level systems processes promptly responding requests transaction documentation event recall purposes investigating suspect product illegitimate product requires secretary provide alternative methods compliance requirements including establishing time line compliance small businesses directs secretary enter contract consulting firm conduct technology software assessment feasibility dispensers conducting interoperable electronic tracing products package level sets forth guidance documents issued secretary related suspect illegitimate products secure tracing package level interoperable standards necessary enhance security pharmaceutical distribution supply chain requires secretary establish pilot projects explore evaluate methods enhance safety security pharmaceutical distribution supply chain sec requires wholesale distributors operating state licensure requirements licensed secretary requires wholesale distributors licensed state drug distributed state requires establishes annual reporting requirements wholesale distributors requires secretary establish database licensed wholesale distributors authorizes secretary collect fees licensure requires party logistics providers obtain license secretary license wholesale distributor entity assumes ownership interest products handles requires secretary establish minimum standards terms conditions state federal licensing wholesale distributors lists requirements minimum standards sec prohibits party logistics provider state conducting activities facility provider licensed state drug distributed provider state drug distributed licensed secretary state established licensure requirement establishes annual reporting requirements facilities party logistics provider authorizes secretary assess licensure fees requires secretary establish minimum requirements licensure party logistics providers preempts state local government requirements tracing products distribution system inconsistent stringent addition requirements act inconsistent waiver exception exemption restriction act prohibits state local government establishing continuing standards requirements regulations respect licensing wholesale prescription drug distributors party logistics providers stringent standards act prohibits state regulating party logistics providers wholesale distributor sec deems drug misbranded contain product identifier required act


Summary:
Preserving Access to Orphan Drugs Act of 2013 - Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions (orphan drug) from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.

Makes this Act effective as if included in PPACA.

preserving access orphan drugs act amends patient protection affordable care act ppaca exclude drug biological product approved licensed food_and_drug_administration fda marketing solely rare diseases conditions orphan drug annual fee manufacturers importers branded prescription drug sales exceeding million makes act effective included ppaca


Summary:
Preventing Antibiotic Resistance Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Requires the Secretary of Health and Human Services (HHS) to refuse approval if the applicant fails to make such a demonstration.

Defines “medically important antimicrobial” as a drug intended for use in food-producing animals and composed wholly or partly of: (1) any kind of specified antibiotics, including penicillin and tetracycline; or (2) a drug from an antimicrobial class that is listed on the World Health Organization’s list of critically important antimicrobials.

Requires the Secretary to withdraw approval for the nontherapeutic use in food-producing animals of a medically important antimicrobial marketed for human use unless the Secretary makes a final written determination that, based on either the application holder's demonstration or an HHS risk analysis, there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the drug's nontherapeutic use.

Requires the Secretary to rescind approval of an exemption for investigational use of, or of approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in a food-producing animal two years after the exemption is granted or the application for approval is submitted. Exempts from this requirement any drugs for which there has been found a reasonable certainty of no harm to human health.

Prohibits the administration of a medically important antimicrobial (including by means of animal feed) to a food-producing animal for nonroutine disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producing animal. Requires the administration of the antimicrobial to be: (1) necessary to prevent or reduce the risk of transmission; (2) for the shortest duration possible to prevent or reduce the risk of transmission; and (3) at a scale no greater than the barn, house, or pen level and to the fewest animals possible to prevent or reduce the risk of transmission.

preventing antibiotic resistance act amends cosmetic act require applicant approval new animal drug medically important antimicrobial demonstrate reasonable certainty harm human health development antimicrobial resistance attributable nontherapeutic use drug requires secretary health_and_human_services hhs refuse approval applicant fails demonstration defines medically important antimicrobial drug intended use food producing animals composed wholly partly kind specified antibiotics including drug antimicrobial class listed world_health_organization list critically important antimicrobials requires secretary withdraw approval nontherapeutic use food producing animals medically important antimicrobial marketed human use secretary makes final written determination based application holder demonstration hhs risk analysis reasonable certainty harm human health development antimicrobial resistance attributable drug nontherapeutic use requires secretary rescind approval exemption investigational use approval new drug application medically important antimicrobial nontherapeutic use food producing animal years exemption granted application approval submitted exempts requirement drugs found reasonable certainty harm human health prohibits administration medically important antimicrobial including means animal feed food producing animal disease control significant risk disease infection present premises transmitted food producing animal requires administration antimicrobial necessary prevent reduce risk transmission shortest duration possible prevent reduce risk transmission scale greater barn house pen level fewest animals possible prevent reduce risk transmission


Summary:
Dietary Supplement Labeling Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the registration requirements for a dietary supplement manufacturing or processing facility to: (1) require the submission of a description, ingredient list, and label and labeling for each dietary supplement product manufactured or processed; and (2) require a manufacturer to update its registration for new, reformulated, or discontinued products within 30 days.

Requires the Secretary of Health and Human Services (HHS) to compile a list of dietary supplement ingredients and proprietary blends of ingredients that could cause potentially serious adverse events, drug interactions, contraindications, or potential risks to subgroups such as children and pregnant or breastfeeding women.

Directs the Secretary to enter into a contract with the Institute of Medicine to: (1) evaluate the safety of dietary supplement ingredients and proprietary blends of ingredients that the Institute determines could cause potentially serious adverse events, drug interations, contraindications, or potential risks to subgroups; and (2) identify proprietary blends of ingredients for which the weight per serving of the ingredient in the proprietary blend should be provided on the label.

Deems a dietary supplement that does not meet the requirements of this Act to be misbranded.

Requires the Secretary to establish a definition for the term “conventional food” for purposes of the FFDCA, taking in account foods marketed as dietary supplements.

dietary supplement labeling act amends cosmetic act ffdca expand registration requirements dietary supplement manufacturing processing facility require submission description ingredient list label labeling dietary supplement product manufactured processed require manufacturer update registration new discontinued products days requires secretary health_and_human_services hhs compile list dietary supplement ingredients proprietary blends ingredients cause potentially adverse events drug interactions contraindications potential risks subgroups children pregnant breastfeeding women directs secretary enter contract institute_of_medicine evaluate safety dietary supplement ingredients proprietary blends ingredients institute determines cause potentially adverse events drug contraindications potential risks subgroups identify proprietary blends ingredients weight serving ingredient proprietary blend provided label deems dietary supplement meet requirements act misbranded requires secretary establish definition term conventional food purposes ffdca taking account foods marketed dietary supplements


Summary: Restoring Access to Medication Act - Repeals provisions of the Patient Protection and Affordable Care Act that restrict payments from health savings accounts, medical savings accounts, and health flexible spending arrangements for medications to prescription drugs and insulin only (thus allowing payments for over-the-counter medications).

restoring access medication act repeals provisions patient_protection affordable care act restrict payments health savings accounts medical savings accounts health flexible spending arrangements medications prescription drugs insulin allowing payments counter medications


Summary: Act to Ban Zohydro - Ends the sale and distribution of pure hydrocodone bitartrate extended-release capsules (marketed as Zohydro ER) within 45 days by withdrawing approval for its new drug application. Prohibits the Commissioner of Food and Drugs (FDA) from approving any new drug application for the capsules unless they are formulated to prevent abuse.

act sale distribution hydrocodone extended release marketed days withdrawing approval new drug application prohibits commissioner food_and_drugs fda approving new drug application formulated prevent abuse


Summary:
Safe and Affordable Drugs from Canada Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Secretary of Health and Human Services (HHS) to promulgate regulations permitting individuals to safely import into the United States, with exceptions, a prescription drug purchased from an approved Canadian pharmacy that:

 is dispensed by a pharmacist licensed in Canada; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FFDCA. Provides criteria for approval of a Canadian pharmacy.

Requires HHS to publish a list of approved Canadian pharmacies, including their website address, from which individuals may purchase prescription drugs in accordance with this Act.

safe affordable drugs canada act amends cosmetic act ffdca require secretary health_and_human_services hhs promulgate regulations permitting individuals safely import united_states exceptions prescription drug purchased approved canadian pharmacy dispensed pharmacist licensed canada purchased personal use quantities greater day supply filled valid prescription issued physician licensed practice united_states active ingredient ingredients route administration dosage form strength prescription drug approved ffdca provides criteria approval canadian pharmacy requires hhs publish list approved canadian pharmacies including website address individuals purchase prescription drugs accordance act