FDA To Regulate Compounding Pharmacies

Increased regulation could bring an end to small compounding pharmacies in the era of Big Pharma.
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    A compounding pharmacy in  San Francisco, California, where custom medications are made for patients with unique needs and are regulated by their state. (Photo Paul Lowry via Flickr)

    A compounding pharmacy in San Francisco, California, where custom medications are made for patients with unique needs. (Photo Paul Lowry via Flickr)

    After a deadly meningitis outbreak traced to a New England compounding pharmacy killed at least 50 Americans last year, the U.S. government is poised to step in and increase regulation of these niche facilities through the Food and Drug Administration (FDA). It could shake up an entire industry struggling to recover from a string of safety and health concerns after increased inspections.

    Introduced in May, bill S. 959: The Pharmaceutical Quality, Security, and Accountability Act proposes federal oversight of an industry that allows pharmacists to create custom medications to suit specific patient needs. This includes combining, diluting or reconstituting an existing drug for patients who may have an allergy or sensitivity to commercially produced medications. The bill is still in committee and has not been put to a vote before the Senate or House.

    The industry has functioned with few major incidents until the major meningitis outbreak last year. Here’s the latest on that story: CBS News reported earlier this month that the disaster began when 17,000 vials of a steroid were shipped to clinics and hospitals in 23 states last fall. The vials were contaminated with a fungus that killed at least 48 users and sent another 700 to seek treatment for persistent fungal infections.

    It’s still unclear how the breakdown occurred, but it’s not the only incident that has patients concerned about the safety of the drugs produced in these facilities.

    Since the fungal meningitis outbreak, the FDA has increased inspections at compounding facilities, finding a number of violations at pharmacies across the U.S.

    USA Today reports that the FDA announced a voluntary nationwide recall of all sterile products from a Texas compounding pharmacy this month after reports that 15 patients at two Texas hospitals have developed bacterial bloodstream infections after they received injections from Specialty Compounding from Cedar Park, Texas.

    This incident follows a report from The Salt Lake Tribune claiming that an inspection at the University Pharmacy Inc. in Salt Lake City was found to have multiple sanitation violations during safety inspections earlier this year.

    The pharmacy was visited five times in February by FDA inspectors, who reported finding equipment and utensils used to mix injectable drugs were not sanitized frequently enough to prevent contamination.

    “Spills and splatters of amber and white colored residue were observed in and around the equipment,” their inspection report says.

    But opponents of the increased federal regulation say that states that are already tasked with regulating these facilities can handle the safe administration of compounding pharmacies. Toward this end, the Boston Globe reports that the state of Massachusetts Department of Health recently closed two compounding pharmacies, in Quincy and Norwood, after a surprise inspection revealed multiple safety violations.

    “The Department of Public Health has made great strides to enhance oversight of the pharmacy industry in Massachusetts since last fall,” Roach said. “The Governor provided more than $1 million in new funding in this year’s budget to enable the Board to hire additional staff to enhance inspections of pharmacies.”

    Some critics also believe that increased federal regulation could bring an end to the small “mom and pop” compounding pharmacies that are clinging to business in an era dominated by big drug manufacturers.

    “The bill, S. 959, would subject mom and pop compounding pharmacies to many of the same regulations as the big drug manufacturers. If it were to pass, the result would be many small mom and pop businesses shutting their doors permanently,” writes Glenn Jacobs of the Daily Caller.

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    • Nariman10

      Hey that’s my neighborhood place in the photo

    • Dr Barry

      This bill will increase the costs of many medications up to 10 times. The steroids that were contaminated were actually relabeled manufactured products and were NOT even compounded. Let the states regulate their pharmacies. The FDA is notorious for poor oversight and is paid off by big pharma.

      Dr. Barry

    • Sally Freyer

      Some “Mom and Pop” compounding shops have sophisticated business models that are interconnected with nationally franchised, compounding supplier companies that sell memberships, untested formulas, raw pharmaceutical ingredients and marketing materials for making drugs from scratch. Add them all up, and they compete with some of the nation’s larger pharmaceutical companies. But, because they follow a geographically distributed model, the drugs they produce can escape FDA verification for safety, efficacy, manufacturing quality and labeling requirements for safe use. Caveat emptor.