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

  • 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.

  • In September 2018, FDA released draft guidance on product identifiers required under the Drug Supply Chain Security Act.

  • 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.

  • 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.

  • 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.

  • Our scope was to evaluate the feasibility of a blockchain based solution for compliance with The Drug Supply Chain Security Act (DSCSA) requirements related to the interoperable, electronic tracing of products at the saleable unit and homogenous case packaging level.

  • Received the product from a person that is authorized as required under the federal Drug Supply Chain Security Act.

  • Had systems and processes in place to comply with verification requirements under the federal Drug Supply Chain Security Act.

  • A homeopathic drug marketed in accordance with applicable guidance under the federal Drug Supply Chain Security Act.

  • An application for an Eldercare Facility Unified Permit shall follow the procedures set forth in Sections 14.00 B.4., 14.00 B.7. through B.11.

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.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • 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 a lawful order of a practitioner for a drug or device for a specific patient that is communicated to a pharmacist.

  • 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 the products listed in Annex I to the Treaty, with the exception of fishery products, as well as cotton;

  • 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;

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • Turnover of zero-rated supply of goods means the value of zero-rated supply of goods made during the relevant period without payment of tax under bond or letter of undertaking;

  • 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 filed with the FDA in accordance with Applicable Law.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • 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/.

  • Red Hat Products means Software, Services, Subscriptions and other Red Hat branded offerings made available by Red Hat.

  • Collaborative pharmacy practice agreement means a written and signed

  • 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.

  • Clinical Supply Agreement shall have the meaning set forth in Section 7.2.

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

  • 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.