Drugs

Section 503B Compounding Enforcement Discretion

FDA says it does not intend to take regulatory action against an outsourcing facility for compounding a drug product using a bulk drug substance that is not on the Section 503B bulks list if the drug (1) appeared on the agency’s drug shortage list within 60 days of distribution and dispensing and (2) was to fill an order that the outsourcing facility received for the drug while it was on the drug shortage list. The enforcement discretion policy is in a draft guidance, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act. The document says FDA believes the public health is best served if it develops the 503B bulks list rather than using its limited resources to categorize newly nominated substances.

The guidance says although the agency intends to continue to receive and evaluate new nominations of bulk drug substances for possible inclusion on the Section 503B bulks list, it will not place such nominated substances in categories published on the FDA Web site before evaluating them.

The guidance also says FDA does not at this time intend to take action against an outsourcing facility for compounding a drug using a bulk drug substance that does not appear on the 503B bulks list and that is not used to compound a drug that appears on the FDA drug shortage list at the time of compounding, distribution, and dispensing, provided five specified conditions are met.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome