Hot on the heels of the Drug Quality and Security Act (H.R. 3204) being signed into law, FDA issued three draft industry guidances reflecting the agency’s current thinking on the compounding part of the new compounding and track-and-trace legislation before implementation begins.
According to APhA’s analysis of the draft guidance of particular interest to most pharmacists, “Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act,” more pharmacists than initially anticipated may be affected if FDA’s thinking informs its future regulations.
“When we think of compounders, we think of brick-and-mortar pharmacies mixing lotions,” said Michael H Ghobrial, PharmD, JD, APhA Associate Director of Health Policy. “FDA has said their enforcement regarding traditional compounding in these settings is going to be very similar to what was in place before the passage of H.R. 3204. This guidance could have a significant effect on compounders of sterile products, especially if the guidance is translated into regulations in the future.”
The current guidance does provide some clarity to compounders, according to Jillanne Schulte, JD, APhA Director of Regulatory Affairs. “Guidance is advice,” but does not have the force of law, she emphasized. “It’s a safe harbor. If you’re complying with the guidance, it’s unlikely that you’re going to be in any enforcement danger.” Will future compounding regulations substantially mirror this guidance? “I think [FDA] thought they were offering some clarity,” said Schulte. APhA will comment on this draft guidance and may comment on the other two draft guidances that cover compounding pharmacies that voluntarily register with FDA as outsourcing facilities. Comments on the draft guidances are due February 3, 2014.
The draft guidance suggests that compounding under section 503A of the Food, Drug, and Cosmetic Act be done in accordance with U.S. Pharmacopeia (USP) chapters <795> and <797>. Compliance with USP <795> for nonsterile compounding would not pose a significant cost or implementation burden to pharmacies. Compliance with USP <797> for sterile compounding, however, could generate implementation costs for some pharmacies, according to APhA.
“A lot of traditional pharmacy compounding is not sterile. But if they are compounding sterile products and they cannot comply with <797>, then [if the draft guidance becomes law,] they would have to get themselves up to standard,” according to Schulte.
Should the draft guidance become law, any potential new expenses for sterile compounders would fall into the categories of facility design; environmental testing; personnel training and competency testing; and maintaining sterility, purity, and stability of dispensed and distributed compounding sterile products. That last item, which would put the duty on the compounder to ensure that the product remains in accordance with all the <797> requirements until it gets to the patient, sets up sterile compounders for “potential liability,” Ghobrial said.
Compounding pharmacies located in states that do not have a memorandum of understanding (MOU) in place between FDA and their state could not ship more than 5% of their prescription volume of compounded products outside of the state. This limitation, known as the 5% rule, would not go into effect until 90 days after FDA finalizes a new MOU through rulemaking with comments from stakeholders. FDA has not yet begun this process. An MOU can be thought of as a short contract or an agreement that compounders will comply with certain rules when they’re distributing compounded drugs, Schulte said. MOUs would vary from state to state.
One pharmacist who would feel an impact is Cheri Garvin, BSPharm, owner and CEO of Leesburg Pharmacy and the Compounding Center in Leesburg, VA—the only accredited compounding pharmacy in the Washington, DC, metro region. “One of my concerns as a practitioner is that I do not know how my state will respond to the request for the MOU. Because I am in a border town very close to Maryland and very close to DC, if this MOU were not in place, I would be limited to dispensing less than 5% of my prescriptions across state lines,” Garvin said. “That would really affect us.”
The draft guidance also indicates that FDA will regulate the bulk substances drug list but will not enforce that list until the regulations are finalized. FDA is seeking nominations for the Pharmacy Compounding Advisory Committee, which will oversee some of the rulemaking. “Another thing we’re waiting on with this guidance is additional information regarding ‘office-use’ and also repackaging and how it’s going to be treated under the law,” said Schulte. That information is being drafted by FDA.