US: FDA issues drug compounding small entity compliance guide

27-05-2019

US: FDA issues drug compounding small entity compliance guide

(Source: RAPS 2019-05-28)

The US Food and Drug Administration (FDA) on Thursday issued a new questions and answers guidance intended to explain how small entities can comply with its recent final rule detailing the bulk drug substances that can be used in compounded drugs.

In February, FDA finalized its list of bulk drug substances that can be used to compound drugs under Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The list currently includes six bulk drug substances, as well as four bulk substances that cannot be used in compounding.

According to FDA, the small entity compliance guide is being issued in compliance with the Small Business Regulatory Enforcement Fairness Act because the agency did not have enough data on the impact of the final rule in small businesses.

The seven-page guidance includes 10 questions and answers meant to help small entities, such as licensed pharmacists and physicians, comply with the 503A bulk drug substances rule.

Some of the topics addressed in the guidance include what pharmacists should do if they receive a prescription for a compounded drug that includes an ingredient that was excluded from the 503A list and how FDA evaluates substances for inclusion on the list.

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