President Barack Obama has signed the Drug Quality and Security Act (H.R. 3204) into law. 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, will affect very few pharmacists. 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.”
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