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.
Bill could force many compounding pharmacies to give up practice, survey finds
HOUSTON — A bill under consideration by the Senate could force more than 40% of compounding pharmacies to abandon compounding, according to a new survey.
PCCA, a company that supplies ingredients, equipment, education and training to independent compounding pharmacies, announced the results of a survey of nearly 800 pharmacists regarding S. 959, the Pharmaceutical Quality, Security and Accountability Act. Slightly more than 41% of respondents also said that the bill would force them to change current business practices in order to remain as a "traditional" compounding pharmacy; about 29% either would not have to change or didn’t know if they would.
S. 959 requires pharmacies engaging in three common practices regulated under state law to register as "compounding manufacturers." Pharmacies included under the bill include those that prepare sterile preparations for human use, prepare them in advance of receiving a legal prescription order or dispense them outside the state in which they’re located.
PCCA said that the bill, despite being proposed to improve the safety of compounded drugs, would force many pharmacies to make choices that it said would decrease the safety of compounded medications and reduce patients’ access to compounded drugs.
The bill was proposed by Sen. Tom Harkin, D-Iowa, in response to last year’s contamination scandal centered on the New England Compounding Center, which resulted in a nationwide outbreak of fungal meningitis that sickened hundreds and killed dozens. The outbreak led to calls for stricter regulations of compounding pharmacies, particularly those that engage in sterile compounding of injected drugs. Sterile compounding differs from non-sterile compounding in that the latter typically involves the making of suppositories, ointments and other simple preparations by a pharmacist for a single patient under orders from a physician. Sterile compounding typically involves specialty drugs.
"The sponsors of S. 959 claim that this legislation will not affect community pharmacies," PCCA president Jim Smith said. "In fact, 41% of the respondents to this survey meet the bill’s criteria for ‘manufacturing.’ The survey showed that pharmacies would be either forced to give up their pharmacy business or make painful changes to their business that would greatly reduce access to compounded preparations."
Teva launches generic version of Astellas’ Adenoscan
JERUSALEM — Teva Pharmaceutical Industries has become the first to launch a generic drug for treating certain heart patients, the company said.
Teva announced the launch of adenosine injection, a generic version of Astellas Pharma’s Adenoscan. The drug is used in combination with thallium-201 in patients undergoing myocardial perfusion scintigraphy who are unable to exercise adequately.
Adenoscan had sales of $65 million during the 12-month period ended in June, according to IMS Health. As the first company to file for approval of the generic, Teva has 180 days in which to market the generic exclusively, according to Food and Drug Administration regulations.