Reports Show States'Compounding Oversight Varies Widely

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By Dana A. Elfin

Feb. 26 — Two reports from the Pew Charitable Trusts released Feb. 24 reveal huge discrepancies in how states oversee the practice of compounding medications.

The two reports—National Assessment of State Oversight of Sterile Drug Compounding and Best Practices for State Oversight of Drug Compounding—show enormous variation in state oversight of compounding and look at best practices for patient safety.

Drug compounding is a practice in which pharmacists specially prepare medicines for individuals unable to take mass-produced medicines due to allergies, swallowing difficulties or other individual needs. Compounding pharmacies generally are overseen by state pharmacy boards, but, in recent years, the FDA has been working to increase cooperative efforts with state pharmacy boards after a deadly outbreak caused by compounded drugs in 2012.

The key finding of the Pew research is that states vary significantly in their policies for sterile compounding, Elizabeth Jungman, director of public health at the Philadelphia-based Pew, told Bloomberg BNA Feb. 25.

State policies on compounding, such as required quality standards, are generally applicable to all compounding activity, regardless of where it takes place, Jungman said.

Opportunities for State Leadership

“It is up to states to require the pharmacies they regulate to follow these standards, and to have the systems in place needed for enforcement,” she said in an e-mail.

“There are real opportunities for leadership for states working to advance reforms to better safeguard patients,” she said.

“Scientists and standards-setting organizations know how to set up facilities to ensure minimal contamination risk when preparing compounding drugs,” Jungman said.

The Pew reports include several recommendations for making oversight of compounding more uniform among the states including applying U.S. Pharmacopeial Convention (USP) quality standards on compounding, inspecting facilities that perform sterile compounding on an annual basis, providing training in sterile compounding for pharmacists who perform or supervise compounding and harmonizing policies on compounding without prescriptions with federal law requirements.

In a Feb. 26 statement, the Houston-based International Academy of Compounding Pharmacists (IACP) praised Pew's “comprehensive” research. IACP also said it supported Pew's recommendation that the United States Pharmacopeial Convention (USP) set standards for compounding practices and strongly recommended that all state Boards of pharmacy adopt all USP standards pertinent to compounding.

“We also agree with the study's theme that state boards should have primary oversight of compounding practices including those in the pharmacy, physician and hospital settings,” the group said.

Deadly Outbreak Spurred New Restrictions

The practice of drug compounding garnered widespread attention after a deadly 2012 nationwide fungal meningitis outbreak that was caused by contaminated, compounded drugs from the Framingham, Mass.-based New England Compounding Center (NECC). The NECC-related outbreak affected more than 700 people, and resulted in 64 deaths in nine states.

The federal Drug Quality and Security Act (DQSA) of 2013 was enacted in the wake of the NECC outbreak to ensure proper oversight of compounding and effective coordination between the Food and Drug Administration and state pharmacy boards.

The DQSA added Section 503B to the FDCA, under which a compounder can register as an outsourcing facility with the FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility can qualify for exemptions from the FDA's drug approval requirements.

But the new requirements also have led to new difficulties, the Alexandria, Va.-based National Community Pharmacists Association told Bloomberg BNA Feb. 25.

NCPA represents independent community pharmacies, which do the bulk of pharmacy compounding in the United States.

About 75 percent of all independent pharmacies in the U.S. participate in compounding, according to John Norton, NCPA's director of public relations.

“Patient access is being endangered and the practice of traditional compounding is being undermined by a lack of flexibility in allowing pharmacies to compound with prescriptions,” Norton told Bloomberg BNA in a Feb. 25 phone interview.

Norton said it is critical that nonsterile compounding standards and sterile compounding standards are applied “across the board to any entity that does compounding, including compounding done in hospitals.”

Concerns About Shortages

Norton said the new requirements also may be leading to shortages of certain compounded medications.

Although many states allow traditional compounding pharmacies to engage in compounding for office use, since the implementation of the DQSA, the FDA has taken the position that traditional compounding pharmacies should only be preparing patient-specific compounds based on a prescription received for a particular patient, Norton said.

This restriction, he said, has created a “conflict in state law and what the FDA is saying.”

Indeed, the Pew research found that 28 states allow traditional pharmacies to compound without a prescription, posing a potential conflict with federal law.

The restriction is also causing access issues, Norton said.

According to Norton, “There is a real need for pharmacy compounders to have the ability to compound nonsterile products for office stock.” Office stock means a compounded preparation a physician has on hand in case of patient need. This is also referred to as compounded preparations for office use.

By prohibiting traditional compounding pharmacies from compounding for office use, the FDA is severely limiting access to these products, he said.

For example, Norton said, most traditional pharmacy compounders have stopped compounding cantharidin for wart removal because of the office use issue.

“This is a challenge for clinics across the nation,” he said, noting that most outsourcing facilities don't compound cantharidin. There are multiple other similar examples, he said, including products as varied as injections for erectile dysfunction, anesthetic gels, ophthalmic injections and emergency eye drops and pain creams.

Meanwhile, Norton said, entities regulated as outsourcing facilities under the DQSA don't seem to be stepping in to meet the need.

“It's very difficult for outsourcing facilities to meet cGMP [current good manufacturing standards] for nonsterile products, and the number of outsourcing facilities providing nonsterile compounds is unknown,” he said.

IACP also said that the issue of office use needs clarification. The group said it's concerned by the Pew study's “claim that all office-use compounding by 503As [traditional compounding pharmacies] is prohibited by the DQSA.”

According to IACP, both Congress and the FDA have voiced support for office use.

When Congress passed the DQSA, there were six on-the-record congressional statements supporting office use, IACP said. It said that the support for office use was reiterated by the approved 2016 Congressional appropriations language and by the FDA within its just-released 2017 appropriations justification. Indeed, IACP said, the FDA has actually stated that office use is needed in some instances.

Meanwhile, the FDA is expected to bring greater clarity to these issues in the near future. Janet Woodcock, director of the FDA's Drug Administration's Center for Drug Evaluation and Research (CDER) has said that CDER's 2016 priorities include implementing a regulatory structure for drug compounding.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Allison Gatrone at agatrone@bna.com

For More Information

The Pew report, Best Practices for State Oversight of Drug Compounding, is available at http://src.bna.com/cQg.

The report, National Assessment of State Oversight of Sterile Drug Compounding, is available at http://src.bna.com/cQh.