Uncertainty Regarding the Future Regulation of Compounding Pharmacies
As we previously reported, the nationwide outbreak of fungal meningitis linked to contaminated injections produced by New England Compounding Center (“NECC”), a compounding pharmacy in Framingham, Massachusetts, prompted calls by the public for better oversight and tighter regulation of compounding pharmacies. In response, Congress and states proposed new legislation in hopes of preventing another public health disaster.
Generally, the operations of compounding pharmacies are regulated by State Boards of Pharmacy, whereas drug manufacturers are regulated by the U.S. Food and Drug Administration (“FDA“). Consequently, drugs produced by compounding pharmacies are not subject to premarket review by the FDA or any other regulatory body, unless state laws so require. The activities of the compounding pharmacy in the NECC case, which involved the manufacture and shipping of drug products across the country, appear to have been much more akin to traditional notions of drug manufacturing than compounding. However, the line separating compounding and manufacturing can be blurry, and in this case it appears to have created a regulatory vacuum. Federal and state lawmakers alike are working aggressively to prevent a similar incident from ever happening again.
In a recent press release, U.S. Representative Ed Markey (D-MA) stated that he is preparing to re-introduce legislation, entitled Verifying Authority and Legality in Drug (VALID) Compounding Act, that aims to increase federal regulatory oversight of compounding pharmacies. The bill, originally introduced on November 2, 2012, died in the previous session of Congress. Overall, the bill preserves state authority to regulate small compounding pharmacies. However, larger compounding pharmacies would be regulated by the FDA as drug manufacturers. In order to determine if a compounding pharmacy is manufacturing drugs, the bill proposes to consider the extent to which such pharmacy sells drugs across state lines, the quantity of the drugs sold, and any other factors deemed appropriate by the Secretary of the Department of Health and Human Services (“HHS“).
In a January 4, 2013 press release, Massachusetts Governor Deval Patrick announced plans to file legislation that would strengthen the states regulation of compounding pharmacies. The proposed legislation would establish strict licensing requirements for compounding sterile drugs; authorize the state Board of Pharmacy to assess fines against pharmacies that violate state policy, regulations, or laws; establish whistle-blower protection for pharmacists and pharmacy staff; and reorganize the state Board of Pharmacy to include more members who are independent of the pharmacy industry. Governor Patrick stated that the proposed legislation, in addition to random, unannounced inspections of compounding pharmacies, would help ensure the safety of compounded drugs.
Although lawmakers seem eager to find ways to prevent another regulatory oversight like the one in Massachusetts from happening in the future, it remains to be seen what steps Congress and states will take to address gaps in the present regulatory scheme. Fuerst Ittleman David & Joseph, PL will continue to monitor any developments in the regulation of compounding pharmacies. For more information, please feel free to contact our offices by email at email@example.com or by phone at (305) 350-5690.