Lawmakers Attempt to Strengthen Regulation of Compounding Pharmacies

Dpk-meningitis-exserohilum2.jpgA bill introduced late in the most recent session of the U.S. Congress would have enhanced federal regulation of compounding pharmacies. The bill never made it out of its committee, but the representative who introduced it says he plans to try again in the new session. At least one state governor has also proposed a state-level bill, and a nationwide organization is conducting its own pharmacy inspections. The nationwide outbreak of fungal meningitis in late 2012, traced to a compounding pharmacy in Massachusetts, was a major factor in bringing about these actions.

Congressman Edward J. Markie, the Democratic representative for Massachusetts’ Fifth District, introduced H.R. 6584, The Verifying Authority and Legality in Drug (VALID) Compounding Act on November 2, 2012, not long before the end of the Congressional session and only a few days before the 2012 Presidential Election. It gained eight cosponsors, and was referred to the House Subcommittee on Health, where it remained, and died, at the end of the 112th Congressional Session. Given the turbulent political atmosphere in Washington DC at the time, it is perhaps not surprising that the bill gained little support or attention. Markey has stated that he intends to reintroduce the bill in the 113th Congress.

The VALID Compounding Act would give the U.S. Food and Drug Administration (FDA) authority over large compounding pharmacies, particularly those that act as drug manufacturers. Smaller “traditional” compounding pharmacies would be exempt from FDA regulation, provided that only licensed pharmacists or physicians personally compound drugs for individual patients with valid prescriptions, the pharmacy uses best manufacturing practices and approved ingredients, and it does not copy commercial drugs. Compounding pharmacies could request waivers of the three restrictions from the FDA in cases of drug shortages or if it is deemed necessary for public health. The law would also create a public list of drugs that should not be compounded, and would require labeling of compounded drugs to indicate that the FDA has not tested or approved the drug.

Massachusetts governor Deval Patrick proposed a state-level set of regulations for compounding pharmacies in early January 2013, which received the support of Rep. Markey. Other states may follow suit in proposing their own sets of regulations. Patrick’s bill would create a special state license for compounding pharmacies, as well as a license for compounding pharmacies based in another state with one or more locations in Massachusetts. It would overhaul an oversight board to review pharmacies that come under federal or state investigation, and it would provide protection to pharmacy employees that report errors, risks, or injuries.

While lawmakers are considering legislative measures to promote safety in compounding pharmacies, the National Association of Boards of Pharmacy (NABP) is undertaking investigative efforts. It reports that it conducted inspections at six compounding pharmacies in four states as part of an agreement with the Iowa State Board of Pharmacy, which wants to strengthen its oversight of pharmacies with Iowa licenses located in other states. The NABP’s campaign is similar to what the FDA would do if authorized by a federal statute.

The pharmacy error attorneys at Lebowitz & Mzhen can assist Maryland victims who have been injured by drugs prescribed, dispensed, or administered incorrectly. To schedule a free and confidential consultation to discuss your case, contact us today online or at (800) 654-1949.

More Blog Posts:

Contaminated Medicine Believed to Be Source of Nationwide Fungal Meningitis Outbreak, Pharmacy Error Injury Lawyer Blog, October 27, 2012
Woman Injured by Medication Error During Eye Surgery Gets New Trial, Pharmacy Error Injury Lawyer Blog, September 13, 2012
FDA Accuses Franck’s Pharmacy of Illegal Compounding, Pharmacy Error Injury Lawyer Blog, May 21, 2010
Photo credit: By U.S. Government [Public domain], via Wikimedia Commons.

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