FDA Considers Compounding Pharmacy Regulations


Gottlieb says that changes may be coming, but remains firm on current regulations.

The FDA is planning changes to its current regulations that guide compounding pharmacies, potentially removing some of the scrutiny from smaller 503A pharmacies.

This is according to a Reuters interview with FDA commissioner Scott Gottlieb, who said that the agency is working toward a policy aimed at encouraging more compounding pharmacies to register under the Drug Quality and Security Act (DQSA). The DQSA was passed in the wake of the New England Compounding Center meningitis outbreak-for which owner Barry Cadden was sentenced to nine years in prison.

Scott GottliebUnder the DQSA, two separate types of compounding pharmacies were created, in sections 503A and 503B. 503B compounding pharmacies, also known as outsourcing facilities, are able to create bulk amounts of drug without individual prescriptions. They must register with the FDA. Smaller 503A compounding pharmacies are not required to register with the FDA, but can only compound medication with a prescription for a specific patient.

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Only around 70 pharmacies have registered as 503B facilities, while there are about 7,500 pharmacies specializing in compounding. To encourage more pharmacies to register, Gottlieb said that the FDA is considering creating levels of enforcement priority based on the size of the facility and the danger of the drugs it compounds. This would allow smaller facilities to register, but not be subject to the same strict policies guiding larger facilities.

“We’re looking at ways we can provide more of a gradation in our regulatory architecture so we don’t have a one-size-fits-all approach,” said Gottlieb. He added that the new policy would help put more pharmacies in compliance with manufacturing standards, which in turn could possibly create more access to compounded medications. “I want to move more of them into a compliant space, and I‘m willing to work with compounders and the broader community to find some regulatory accommodation that gets more of them into a compliant space,” he said.

However, pharmacy organizations are still wary of the FDA’s interpretation of the DQSA. In a statement to Drug Topics, the International Academy of Compounding Pharmacists (IACP) said that the FDA was overstepping Congress’s intent. According to the IACP, statements made during the passage of the bill “made clear that office-use compounding was to be left to state law and that the memorandum of understanding found within section 503A was not to include dispensing.”

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In an

FDA listening session

, APhA made it clear that it also has problems with the FDA’s current implementation of the DQSA. APhA said that it has received multiple reports of 503A pharmacies undergoing the same rigorous inspection requirements as 503B facilities. Those 503A facilities are cited for failing to meet 503B good manufacturing practices. Neither IACP nor APhA were willing to specifically comment on Gottlieb’s recent comments without reading a draft of proposed guidelines. However, IACP stressed that it or “other pharmacy industry stakeholders have not been asked by FDA to provide input on this guidance.”

Unrelated to Gottlieb’s comments or possible FDA actions, IACP noted that it supports H.R. 2871, the Preserving Patient Access to Compounded Medications Act of 2017. According to IACP, “H.R. 2871 will help clarify the DQSA in a way that will better align the statute with congressional intent. Congress has been clear; IACP wants the FDA to implement DQSA pursuant to Congressional intent as outlined in legislation and other efforts.”

Gottlieb said that the draft guidance on new FDA rules would be released in the next two months.

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