FDA Adds New Compounding Pharmacy Regulations

In an effort to clarify existing rules and regulations-and create new ones-the FDA has announced its plans and priorities for compounding pharmacy in 2018.

Scott Gottlieb, MD, FDA Commissioner says that “because of the profound public health implications,” compounding pharmacy is a “priority.”

A large part of that priority is encouraging more compounding pharmacies to register as 503B pharmacies, so-called outsourcing facilities that are able to produce drugs in bulk supply but are subject to stricter safety standards. “Our policy goal,” continues Gottlieb, “is to make it more efficient and lower cost for more compounding pharmacies to voluntarily meet the higher production standards for 503B outsourcing facilities as a way to promote more patient access to higher quality compounded medicines.”

However, encouraging more registration is not the only goal. Last October, Endo International Plc sued the FDA, accusing the agency of allowing compounding pharmacies to create “essentially a copy” of its blood pressure drug Vascostrict (vasopressin). While Gottlieb made no mention of the suit in his statement, he did say that the FDA has “heard concerns about compounding from bulk drug substances when the drug can be compounded from FDA-approved drugs.”

Related article: How the NECC Case Changed Compounding Pharmacy

Under its new plan, the FDA is seeking to more closely define the necessity of compounded medication, stressing that they “should only be distributed to meet the needs of patients whose medical needs cannot be met by an FDA-approved drug.”

To avoid copying existing medications, the agency will be focused on examining whether there is any clinical difference between a compounded drug and a commercially-available drug. It will also review situations it says could impact public health, such as compounding a bulk drug substance instead of diluting a commercially-available drug.

The other large portion of the 2018 goals includes refining the regulations for and communications with states. The FDA reportedly received over 3,000 comments related to the relationship of the FDA and states, and has consequently “substantially revised” the Memorandum of Understanding (MOU) between the FDA and the states.

The revised MOU addresses issues the ability of 503A compounding pharmacies-smaller facilities only able to compound for patient-specific cases-to ship across state lines. Under the new regulation, 503A pharmacies can ship across state lines only if more than 50% of their drugs remain in state. The FDA is also giving states more time to report on issues, and more flexibility in how they can identify issues than was previously allowed-such as having to rely on inspection records to identify pharmacies shipping more than the allowed amount across state lines.

Related article: Compounding Pharmacy’s License Suspended

This will, according to Gottlieb, give states the ability to “focus on notifying the FDA of those compounders where the size or scope of the activities merits greater oversight. Our aim is to leave the oversight of traditional pharmacy to states.”

Other plans include:

• Allowing 503B facilities to assign beyond-use dates to repackaged biologicals that exceed the default 24 hours based on data
• Further explain the definition of a 503B, if it can be co-located with 503A facility
• Additions and modifications to the list of products that can no longer be used for compounding

“Ultimately, there’s no question that the framework we will be laying out will place more restrictions on what they can do,” Gottlieb told Reuters.