Compounding pharmacies, which customize drugs for individual patients, say the FDA is overstepping its authority and jeopardizing patient access to compounded medications.
The pharmacies say the Food and Drug Administration has misinterpreted Congress’s intent when it enacted the Drug Quality and Security Act (DQSA) of 2013 by not allowing office-use compounding. Office-use compounding is when a pharmacist makes a drug without receiving a prescription and transfers it to a requesting physician to keep on hand for when it is needed by a patient.
The pharmacies also are concerned that the FDA has issued no rules for compounding but only guidance documents, which aren’t legally enforceable.
“Mass confusion has resulted from the usage of guidance documents, and the FDA is definitely circumventing the Administrative Procedure Act (APA) in our opinion,” Cynthia Blankenship, executive vice president of the International Academy of Compounding Pharmacists (IACP), told me. The APA governs how federal agencies propose and establish regulations.
IACP wants Congress to pass a bill (H.R. 2871) they say will fix these issues. Under the bill, if state law authorizes office-use compounding then it wouldn’t be considered a violation. It also requires the FDA to go through rulemaking under the APA, among other things. The bill was introduced by Rep. Morgan Griffith (R-Va.) in June.
However, it’s unclear whether the bill will advance. Griffith said in an Oct. 19 statement provided to Bloomberg Law, “We hope that it will move forward at some point, but we have to do some more ground-building before it will move forward.”
Meanwhile, the FDA says its oversight of compounding pharmacies is essential to ensuring patient safety and says allowing office-use compounding could lead to contaminated drug products. The FDA also says it is encouraging more compounding pharmacies to register with the agency as outsourcing facilities, which are permitted to provide compounded drugs for office use because they are subject to higher manufacturing standards.
The DQSA, which was enacted after a deadly outbreak of fungal meningitis from compounded drugs provided by a pharmacy in Massachusetts in 2012, distinguishes between compounders engaged in traditional compounding and those compounders making large volumes of compounded drugs without individual prescriptions. Compounders wanting to make larger amounts of drugs without individual prescriptions can voluntarily register with the FDA as outsourcing facilities and become subject to federal manufacturing oversight like brand-name and generic drug manufacturers.
Julie Dohm, senior science adviser for compounding in the FDA’s Center for Drug Evaluation and Research, told me no facility would register as an outsourcing facility and become subject to federal oversight and pay the required fees to the FDA if they could remain a 503A compounding pharmacy and do the same thing, which is distribute nonpatient specific drugs for office use. “We obviously recognize how important it is for the outsourcing facilities to be able to meet the need for nonpatient specific compounded drugs. That’s what they were created to do, that’s what they’re allowed to do,” she said.
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