FDA rolls out draft guidelines that narrowly define what drugs compounding pharmacies can make

The FDA, which has been scrutinizing compounding pharmacies for the past four years, recently issued two draft guidelines it hopes define when compounders are allowed to produce versions of commercially available drugs.

The draft guidelines were released by the regulatory agency last week and are targeted at making sure a valid clinical need exists before a compounded version of an approved drug can be made for a patient.

Even though a new federal law says compounders shouldn’t make copies of drugs that are approved for sale, the guidelines are an attempt to refine the FDA’s interpretation of that law.

“The FDA is making a policy statement that you can’t just compound a copy and then market it,” Elizabeth Jungman, director of public health at Pew Charitable Trusts, a nonprofit that studies healthcare issues, told the publication Stat. “There has to be a patient need. And it’s important from a safety perspective.”

Under the guidelines, compounders can make versions of brand-name drugs when a shortage exists or the brand-name medicine has been discontinued. Additionally, a compounding pharmacy could produce a drug for a patient if there is a required change in formulation, such as different dosage strengths.

In its guidelines, the agency also pointed out that making a lower priced compounded version of a drug isn’t justification for compounding an FDA-approved medicine.

Regulatory attention of compounders increased in 2012 when the New England Compounding Center was charged with manufacturing a steroid that triggered a deadly fungal meningitis outbreak.

Fourteen of the center’s owners and employees were indicted in 2014 on charges they peddled unsterile drugs that infected hundreds of patients with fungal meningitis. The indictment also included 25 murder charges against two lead pharmacists, a move that didn’t go unnoticed throughout the entire pharma industry.

- check out the Stat story
- see the FDA draft guidelines

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