Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Friday, February 14, 2020
FDA Provides Additional Time for Stakeholders to Comment on Revised Draft Guidance on Animal Drug Compounding from Bulk Drug Substances
In response to requests to extend the comment period for the revised draft guidance, “Compounding Animal Drugs from Bulk Drug Substances,” the FDA plans to provide an additional 120 days for the public to submit comments. The initial comment period is scheduled to end on February 18, 2020, but FDA will be reopening the comment period using the same docket number. Otherwise, the submission process remains unchanged.
The new deadline to receive comments will be June 17, 2020.
The Federal Register Notice for the reopening of the comment period is forthcoming. A link will be provided on or shortly after February 20, 2020.