EAS would like to bring to your attention, the Statement from FDA Commissioner Scott Gottlieb, MD regarding drug compounding outsourcing facilities. The Drug Quality and Security Act (DQSA) was enacted by Congress in 2013 in response to a significant safety issue experienced by the public as the result of poor drug compounding practices. As seen with recently issued warning letters, the FDA is also prioritizing enforcement of section 503B of the Federal Food, Drug and Cosmetic Act which allows for compounded drugs which are not FDA-approved and do not undergo premarket review by the FDA for safety, effectiveness, and quality. In the FDA’s ongoing efforts to enact measures to ensure this allowance is exercised only when necessary and appropriate, and in a safe manner with assured product quality, they have released the Draft Guidance Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug and Cosmetic Act. In this guidance, the FDA addresses their plan to formulate the “503B bulks list”, a list of bulk drug substances determined by the FDA as clinically necessary for outsourcing facilities to use for compounding drugs. Follow the links for further information.
Now that the dust has settled with the 2017 FDA requirement to certify all drug listings annually, we would like to bring to your attention the necessity to complete expired listings. Under 21 CFR 207.57(b), registrants must submit updated listing information at each June and December if there is change since the previous listing and they must submit this information to the FDA via electronic format. These changes include any drug recently introduced into U.S. commercial distribution which was not previously listed, any drug which commercial distribution has been ceased, any drug reintroduced in commercial distribution and any material changes in any drug listing information previously submitted. The FDA has communicated that although listings that were not certified by 31 December 2017 have been changed to an expired status, it is still required to ‘complete’ the marketing status and input an ‘end marketing date’ in order to delist the product. EAS is here to assist with any listing issues you may need to be resolved. Please let us know if we can help.
Guidance Document updates on the FDA website:
OC: Immediately in Effect Guidance for Industry and Food & Drug Administration Staff
- Chronic Obstructive Pulmonary Disease: Use of the St. George’s Respiratory Questionnaire as a PRO Assessment Tool
- E18 Genomic Sampling and Management of Genomic Data
- M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk
- Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act
- Standardization of Data and Documentation Practices for Product Tracing
- E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
- Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) Q & A
OC: Distributed for Comment Purposes Only