Physicians await FDA guidance on drug repackaging by outsourcing facilities

These facilities may provide compounded medications without patient-specific prescriptions but would have to meet high sterility standards.

In the wake of recent federal drug safety legislation, clinicians, pharmacists and patients are awaiting U.S. Food and Drug Administration guidance on regulation of outsourcing facilities that handle compounded drugs.

Some experts are concerned that the law may limit patient access to Avastin (bevacizumab, Genentech) and other vitally needed agents.

The Drug Quality and Security Act (DQSA), passed by Congress and signed into law in 2013, gives the FDA discretion in deciding how repackaged products and drugs produced by traditional compounding pharmacies for office use may be handled.

The FDA has issued guidance limiting office use of compounding pharmacies subject to section 503A of the Food, Drug and Cosmetic Act (FD&C Act). The guidance requires 503A traditional compounders to receive a patient-specific prescription for each compounded drug.

 

However, the agency has not issued guidance on repackaging of drugs by outsourcing facilities subject to section 503B of the FD&C Act.

“We are still waiting for specific guidance on exactly what has to be done and repackaging information on the 503Bs,” Michael X. Repka, MD, American Academy of Ophthalmology medical director for governmental affairs, told Ocular Surgery News.

Repka said that outsourced facilities are subject to stricter safety and quality regulations than traditional compounding pharmacies.

“The outsourcing facility is a higher level of precision, a higher level of safety, and it requires a much higher level than a sterile compounding pharmacy is required to have,” Repka said. “So, there would be fewer of these, but they could provide compounded medications without a patient-specific prescription. But they have to adhere to levels of ability closer to a manufacturer.”

According to the American Society of Cataract and Refractive Surgery, even if the compounders are not restricted, the limited number of facilities that can meet strict outsourcing facility requirements will lead to drug shortages.

“Suppose [facilities] weren’t allowed to repackage an approved product. That might reduce or remove access to Avastin,” Repka said.

Congress, medical groups air concerns

On Oct. 14, 2014, Sens. Thomas Coburn, MD, R-Okla., John Boozman, OD, R-Ark., and Rand Paul, MD, R-Ky., wrote a letter to Margaret A. Hamburg, MD, FDA commissioner, stating the need for compounded and repackaged drugs to be available for office use.

“The FDA has not been forthcoming in providing guidance or a statement on how it will regulate these products under the new law,” the senators wrote.

The senators said the FDA “should act quickly to issue guidance describing how the agency will regulate outsourcing facilities, and such guidance should include a clear statement that outsourcing facilities are allowed to repackage sterile drug products, including biologics, for office use. … The FDA should not prevent physicians from maintaining an appropriate stock of repackaged products for in-office use that is imperative to timely treatment.”

In a letter dated Dec. 8, Thomas Kraus, associate commissioner for legislation, U.S. Department of Health and Human Services, told Coburn that the FDA met with various stakeholders to gather information that will be used to develop additional regulations and guidance on the implementation of compounding provisions contained in the DQSA.

Kraus stated that, to qualify for exemptions from certain requirements of the FD&C Act, compounders must obtain a prescription for an individually identified patient.

“However, facilities that register as outsourcing facilities under the new section 503B of the FD&C may, but need not, obtain patient-specific prescriptions,” Kraus wrote.

In a Dec. 10 letter to the Senate, the AAO, ASCRS, American Society of Retina Specialists and other medical groups expressed concern about implementation of the DQSA and subsequent FDA actions.

“We are deeply concerned about the implementation of the DQSA in regards to both compounded and repackaged medications for office use,” the letter said. “The most recent implementation actions of the FDA have resulted in decreased patient access to vital medications and have caused confusion amongst state boards of pharmacy, health care providers, pharmacists and patients.”

On Dec. 16, the FDA announced the formation of a Pharmacy Compounding Advisory Committee, as required by the DQSA. The committee, which comprises 12 voting members and two non-voting members, will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the FD&C Act, according to an FDA press release. – by Matt Hasson

References:

ASCRS joins coalition urging Congress to ensure access to compounded and repackaged medications; FDA responds to senators. ASCRS website. www.ascrs.org/legislative-and-regulatory/www/article/ascrs-joins-coalition-urging-congress-ensure-access-compounded-and-repackaged-medications-fda.
FDA announces Pharmacy Compounding Advisory Committee members. FDA website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427005.htm. Dec. 16, 2014.
Letter to Margaret A. Hamburg, MD. ASCRS website. www.ascrs.org/sites/default/files/20141014LettertoFDAonCompoundingConcerns.pdf. Oct. 14, 2014.
Letter to Tom A. Coburn, MD. ASCRS website. www.ascrs.org/sites/default/files/COBURNcompounding.pdf. Dec. 8, 2014.
Maintaining patient access to compounded and repackaged medications. ASCRS website. www.ascrs.org/sites/default/files/lettertoCDrugCompounding.pdf. Dec. 10, 2014.