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.
The guidance also instructs compounders who wish to use one of the four bulk substances that were excluded from the list to submit a citizen petition explaining how their use of the substance differs from the use FDA previously evaluated when considering the substance for the 503A list.
The new guidance comes as FDA continues its years long effort to increase oversight of compounders following the 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths.
FDA has also increased its enforcement efforts against compounders found in violation of current good manufacturing practices. On Wednesday the agency announced that federal judges in Illinois and Texas entered consent decrees against two outsourcing facilities, PharMedium Services
and Pharm D Solutions
In April, FDA detailed its priorities
for drug compounding in 2019, which include issuing a new proposed rule to update the list of bulk drug substances that can be used in compounding under Section 503A. FDA also said it plans to update its list of bulk drug substances that can be used in compounding by outsourcing facilities under Section 503B of the FD&C Act.
, Federal Register Notice