The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers.'' This draft addresses questions about and clarifies FDA's expectations for annual reporting to FDA by prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) as required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Drug Supply Chain Security Act (DSCSA).
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Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Annual Reporting by Prescription Drug Wholesale Distr...
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82 FR 3004
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“Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft Guidance for Industry; Availability,” thefederalregister.org (January 10, 2017), https://thefederalregister.org/documents/2017-00233/annual-reporting-by-prescription-drug-wholesale-distributors-and-third-party-logistics-providers-questions-and-answers-d.