Reports: Bill to extend federal regulations for compounding pharmacies expected to pass House, Senate
NEW YORK — Legislation to allow the Food and Drug Administration to strengthen its regulatory powers over compounding pharmacies is expected to pass both houses of Congress after committees agreed on it Thursday, according to published reports.
Reuters reported that House and Senate committees had agreed on a bill: the Drug Quality and Security Act. The bill was proposed in response to last year's outbreak of fungal meningitis, traced to the Framingham, Mass.-based New England Compounding Center. Dozens of people died, and hundreds more were sickened as a result of the outbreak, linked to contaminated injectable steroids used to treat chronic pain. Subsequent inspections of the NECC found widespread contamination in the laboratory and disregard for sanitation.
The kind of compounding done at the NECC, known as sterile compounding, differs from traditional compounding. While the latter involves pharmacists mixing medications from simple ingredients under instructions from physicians — for example, topical creams and mouthwashes — sterile compounding involves the mixture of injected drugs and must be done under strict adherence to sterilization protocols.
The law would distinguish the two types of compounding and focus on pharmacies that engage in sterile compounding and ship their drugs across state lines, while pharmacies that do traditional compounding would continue to be regulated by state boards of pharmacy, according to Reuters.
Another bill in the Senate — the Pharmaceutical Quality, Safety and Accountability Act — would require pharmacies that prepare sterile drugs, prepare them in advance of receiving a prescription or dispense them across state lines to register as "compounding manufacturers." But some pharmacists have criticized that bill. A poll by compounding supplies manufacturer PCCA found that more than 40% of compounding pharmacies would be forced to change current business practices in order to remain as "traditional" compounding pharmacies.