President Barack Obama signed the Drug Quality and Security Act (H.R. 3204) into law on November 27. What are the practical implications for most pharmacists of the new compounding and track-and-trace legislation?
The short answer is that the compounding part of the legislation, which became effective upon enactment, may affect more pharmacists than initially anticipated (see page 56 for more information). The track-and-trace part of the legislation will affect all pharmacists to some extent, according to Michael Ghobrial, PharmD, JD, APhA Associate Director of Health Policy.
Of course, the language in the legislation is not the last word. FDA has to decide how to implement it through the regulatory process. Traditional community pharmacies are “probably” not going to be affected by the compounding part of the law “unless we get more stringent regulation from the FDA,” said Lee Rosebush, PharmD, JD, MBA, MS, Counsel at the BakerHostetler law firm in Washington, DC. “While we got by with 3204, we may not necessarily get by with the regulations proposed by FDA.”
Compounding: Practical impact
Under the new law, traditional pharmacies are still regulated by state boards of pharmacy. Compounding pharmacies are still regulated by state boards of pharmacy, Ghobrial said. But now compounding pharmacies that voluntarily elect to be “outsourcing facilities” are regulated by both state boards of pharmacy and FDA.
“Here’s the big question everybody’s going to be asking: If [registration with FDA] is voluntary, why would you want to have the FDA breathing down your neck? And the answer to that is brilliant,” Ghobrial said. “People will sign up because their product is less likely to be sold if they’re not an FDA-overseen outsourcing facility.”
Traditional pharmacies that do sterile compounding based on specific, individualized prescriptions have no reason to register with FDA, emphasized Rosebush. Pharmacies that are going to supply office use medication, however, have to do the registration. “You’re going to see a business model determination,” Rosebush said. “You’re going to see entities say, ‘Well, is the $15,000 user fee and the cGMP [current Good Manufacturing Practices] compliance worth moving into this new business model?”
Rosebush has “several clients who are large compounding pharmacies,” he said. “I do have some that are willing to register with the FDA and are currently pursuing compliance policies that use cGMPs and USP [U.S. Pharmacopeia] <797> standards. We eagerly await the publication of regulations in this area.” He added, “Some of my clients do not feel that they will have to register with the FDA and are not planning on registering with the FDA.”
continue to read at
http://www.pharmacist.com/how-new-compounding-track-and-trace-law-may-affect-pharmacists-fda-issues-pharmacy-compounding-draft
