Drug Supply Chain Security Act definition

Drug Supply Chain Security Act or “DSCSA” means the law enacted by Congress in November 2013 which establishes the minimum standards for ensuring a legitimate drug supply chain.
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Drug Supply Chain Security Act. (“DSCSA”) means Title II of the federal Drug Quality and Security Act (“DQSA”), which established, among other things, drug product tracing requirements for certain prescription drugs. Information regarding DSCSA is at: https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupp lyChainSecurityAct/.
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Examples of Drug Supply Chain Security Act in a sentence

  • Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility can qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.

  • For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables.The Drug Supply Chain Security Act, referred to in par.

  • Consistent with USG objectives, Regeneron will employ its proprietary manufacturing technology and processes, in a manner compliant with applicable laws and regulations, including 21 CFR 210 and 211 and, to the extent applicable, the Drug Supply Chain Security Act, to manufacture the prototype product.

  • Authorized Trading Partner – as defined in the Drug Supply Chain Security Act, and regulated by the Food and Drug Administration (FDA), compliance requires that transactions only be conducted between Authorized Trading Partner.

  • DSCSA – Drug Supply Chain Security Act EDI - Electronic Data Interchange - Inter-process (computer to computer application) communication of business information in a standardized electronic form.

  • On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) (Title II of Pub.

  • Consistent with USG objectives, Regeneron will employ its proprietary manufacturing technology and processes, in a manner compliant with applicable laws and regulations, including 21 CFR 210 and 211 and the Drug Supply Chain Security Act, to manufacture the prototype product.

  • The Parties agree to strictly comply with the Drug Supply Chain Security Act, and all other laws related to the subject matter of this Agreement.

  • INTRODUCTION This guidance describes FDA’s compliance policy with regard to a requirement related to product identifiers under the Drug Supply Chain Security Act.

  • Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA), includes provisions designed to strengthen the integrity of the pharmaceutical distribution supply chain.

Related to Drug Supply Chain Security Act

  • Food Security Act means the Food Security Act of 1985, 7 U.S.C. §1631, as amended, and the regulations promulgated thereunder.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Prescription drug order means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements. Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • Agricultural product means the products listed in Annex I to the Treaty, except fishery and aquaculture products listed in Annex I to Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013;

  • Criminal drug statute means a Federal or non-Federal criminal statute involving the manufacture, distribution, dispensing, possession or use of any controlled substance.

  • agricultural products means an animal or plant or a product, including any food or drink that is wholly or partly derived from an animal or plant, and includes all after acquired Agricultural Products of the Producer, or any proceeds therefore.

  • Capital Instruments Regulations means the Delegated Regulation and any other rules or regulations of the Relevant Authority or which are otherwise applicable to the Issuer or the Group (as the case may be and, where applicable), whether introduced before or after the Issue Date of the relevant Series of Notes, which prescribe (alone or in conjunction with any other rules or regulations) the requirements to be fulfilled by financial instruments for their inclusion in the Own Funds to the extent required under the CRD IV Package;

  • Patent Cooperation Treaty means the Patent Cooperation Treaty done at Washington on June 19, 1970;

  • Drug abuse means any pattern of pathological use of drugs that causes impairment in social or occupational functioning, or that produces physiological dependency evidenced by physical tolerance or by physical symptoms when it is withdrawn.

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.

  • Supply of goods means the transfer of the right to dispose of tangible property as owner.

  • StarCompliance Code of Ethics application means the web-based application used to electronically pre-clear personal securities transactions and file many of the reports required herein. The application can be accessed via the AB network at: https://alliance-ng.starcompliance.com/.

  • Nonprescription medication means a drug or medication authorized pursuant to federal or state law for general distribution and use without a prescription in the treatment of human disease, ailments, or injuries.

  • Occupational Health and Safety Act means the Occupational Health and Safety Act, 1993 (Act No 85 of 1993);

  • National Road Traffic Act means the National Road Traffic Act, 1996 (Act 93 of 1996);

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • FDA Act means the U.S. Federal Food, Drug, and Cosmetic Act, as amended.

  • Licensed health care practitioner means a physician, as defined in Section 1861(r)(1) of the Social Security Act, a registered professional nurse, licensed social worker or other individual who meets requirements prescribed by the Secretary of the Treasury.

  • land development application means the application for a land development permit on a form provided by [local jurisdiction] along with the supporting documentation required in Section [Y]-10(a).

  • Liquidation Process Regulations means, the Insolvency and Bankruptcy Board of India (Liquidation Process) Regulations 2016 as amended from time to time;

  • agriculturist means an individual or a Hindu Undivided Family who undertakes cultivation of land—

  • ACNC Act means the Australian Charities and Not-for-profits Commission Act 2012 (Cth).

  • FMC Act means the Financial Markets Conduct Act 2013.

  • Agricultural producer means a person that engages or wishes to engage or intends to engage in the business of producing and marketing agricultural produce in this state.