FDA moves to regulate medicines produced in bulk

The U.S. Food and Drug Administration issued a draft guidance in March proposing to regulate medicines that are produced in bulk by compounding pharmacies.

The agency issued a draft guidance that prioritizes the use of FDA-approved drugs over more risky, custom-made medicines produced in bulk by compounding pharmacies for hospitals and doctors’ offices, according to a Reuters report issued on March 23.

The decision stems from a deadly fungal meningitis outbreak in 2012 in which more than 70 people died and more than 700 patients fell ill after receiving medicines from a compounding pharmacy.

If approved, the new rule will steer physicians toward FDA-approved drugs that have met safety and effi cacy standards established in a clinical trials process. Raw substances used in compounded medications can still be used, but only after the prescribing physician has successfully established a clinical need that cannot be met with existing FDA-approved drugs. In many cases, FDA-approved medications can be diluted on a per patient basis, however, doing so will delay treatment until patients fill a prescription for the medication.

“The safest alternative is always an FDA approved product,” FDA Commissioner Scott Gottlieb told Reuters.

Physician advocacy groups have argued that compounding pharmacies and bulk medicines used in-clinic are two entirely unrelated issues.

In dermatology, for example, numbing agents used for daily dermatologic procedures may no longer be able to be used in-clinic if they are mixed on site.

In 2013, Congress passed a law in which it established some 70 outsourcing facilities that could register with the FDA. The facilities can sell products in bulk without individual prescriptions.

The FDA was required to establish a list of substances those facilities could use for bulk compounding that met a “clinical need,” but it has yet to fi nalize one, Reuters reported.

See the related story from Dermatology Times:  “Opposition to looming compounding practice changes"