GDP-relevant Documents from FDA and USP Currently in Commenting Process

Currently, several GDP-relevant documents from the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP) are in the commenting process. 

FDA Proposed Rule "National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers"

In February 2022, the FDA has announced the availability of the proposed rule "National Standards for the Licensure of Wholesale Drug Distributors (WDDs) and Third-Party Logistics Providers (3PLs)". The proposed rule sets national licensing standards for both federal and state licensure for WDDs and 3PLs.

Information on the background and content of the planned changes can be found in the news "Proposed Rule for the Licensure of WDDs and 3PLs published".

The FDA has also posted a webinar to help stakeholders submit comments and understand the proposed changes.

To read the proposed rule and submit comments, please visit the federal register. Comments can be submitted until June 06, 2022.

Draft Guidance for Industry "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs"

On 09 March 2022, the Center for Drug Evaluation and Research (CDER) of the FDA issued a revised draft guidance for industry entitled "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs."

The document addresses the verification systems that manufacturers, repackagers, wholesale distributors, and dispensers must have in place to comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA).

The draft guidance is available on the FDA website.

Drug Supply Chain Security Act Law and Policies and Implementation Plan

The FDA has compiled an overview with all guidance and policy documents, that were issued since the Drug Supply Chain Security Act (DSCSA) was enacted in 2013.

The FDA has also prepared a summary of planned implementation timeframes for the DSCSA over a 10-year period.

USP General Chapter <1079> Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products

In the Pharmacopeial Forum, PF 48(3), a proposal of USP General Chapter <1079> "Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products" has been published for comments.

General Chapter <1079> applies to organizations and individuals involved in the storage and transportation of drug products. It describes a risk-based approach to the storage and transportation of finished drug products and risk mitigation strategies. The chapter also contains a glossary and a list with additional sources of information.

In this case, it is only a minor revision to remove an inappropriate General Notice reference without any changes in content. Nevertheless, this might be of interest, because the entire chapter and also the previously valid version can be viewed free of charge.

The deadline for submitting comments is July 31, 2022. The draft of the revised chapter is available on PF Online. (Please note: a one-time registration is required to access the Pharmacopeial Forum.)

Further USP Chapters and Stimuli Articles

There are also some older GDP-related documents available on the PF Online website, although the comment periods for these are already closed. These include:

• USP General Chapter <659> Packaging and Storage Requirement
• USP General Chapter <1079.2> Mean Kinetic Temperature in the Evaluation of Temperature Excursions During Storage and Transportation of Drug Products
• Stimuli article: The Use of Simulated Transport in the Evaluation of Risks to the Product Quality from the Distribution Process
• Stimuli article: Reusable Passive Thermal Packaging System: Best Practice Guideline