The FDA issued draft guidance last week designed to limit the list of pharmaceutical ingredients that drug compounding pharmacies can use to manufacture drugs in bulk that do not undergo the agency’s traditional approval process.
The move comes in the wake of a deadly 2012 fungal meningitis outbreak that originated from contaminated drugs made in a Massachusetts-based compounding pharmacy. The tainted drugs killed 76 people, according to Reuters.
Compounding pharmacies create patient-specific doses of drug to address specific needs, like a patient’s allergies. But some pharmacies make these modified drugs in bulk, selling thousands of doses to physicians to keep in anticipation of future need.
Drugs prepared at compounding pharmacies are not required to undergo the industry’s usual slew of regulatory hurdles, since the facilities are often modifying already-approved drugs.
The newly-issued draft guidance would limit the list of raw pharmaceutical ingredients that drug compounders can use. The FDA wrote that it would only permit a pharmacy to use a raw substance if it could establish a clinical reason why an FDA-approved drug could not be diluted or crushed to achieve the same result.
“For example, if an approved drug contains peanut oil, the FDA would consider whether there was information indicating that patients with a peanut allergy need a drug product compounded without the allergen,” commissioner Dr. Scott Gottlieb said in prepared remarks.
“The FDA would further consider whether there was information suggesting that the drug product needs to be compounded using a bulk drug substance, rather than the approved drug, because the type and number of manipulations necessary to remove the peanut oil from the approved product would adversely impact the overall quality of the drug,” he explained.