FDA plans more restrictive policy for bulk drug compounding

The head of the U.S. Food and Drug Administration (FDA) said it is preparing a new, more restrictive policy targeting what drugs compounding pharmacies can produce that do not go through the agency’s approval process.

FDA Commissioner Scott Gottlieb said the agency in March will issue draft guidance with new criteria for determining what substances can be used to produce drugs in bulk for hospitals and doctors’ offices without individual patient prescriptions.

“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.

The announcement was one of several by the FDA on Thursday regarding its priorities in 2018 for drug compounding, which involves pharmacists making drugs to meet patients’ specific needs.

Gottlieb said the FDA is also preparing a new policy to give state boards of pharmacy more flexibility to oversee compounding pharmacies that ship drugs interstate and is still working on guidance to encourage more pharmacies to register with the FDA.

According to the American Pharmacists Association, 7,500 pharmacies specialize in compounding medicines, which traditionally involved mixing tailored doses for individual patients in response to a specific prescription.

By 2012, the practice had mushroomed, with some pharmacies selling thousands of doses of regularly used mixtures without prescriptions for physicians to keep for future use.

A fungal meningitis outbreak that year caused by contaminated steroids produced by a Massachusetts compounding pharmacy, New England Compounding Center, sickened hundreds of patients and killed 76, prosecutors said.

After the outbreak, Congress in 2013 passed the Drug Quality and Security Act to bring more compounding pharmacies, traditionally overseen by states, under FDA oversight.

The law established “outsourcing facilities” that could register with the FDA, allowing them to sell products in bulk without individual prescriptions while following federal manufacturing standards.

The FDA was required to determine that bulk compounding using a drug substance was necessary to satisfy an unmet “clinical need” and include those substances on a list.

But the FDA has not yet developed a final list of those substances, and instead adopted an interim policy allowing bulk compounding using drug substances that compounders could nominate for eventual inclusion on the list.

In October, Endo International Plc subsidiaries filed a lawsuit arguing that under that policy, the FDA had improperly authorized the bulk compounding of hundreds of drugs, including essentially a copy of its blood pressure drug Vasostrict.