Legislation may increase oversight of compounders
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Legislation signed in November 2013 will give federal authorities more scrutiny over some compounding pharmacies, which will be able to market themselves as more regulated.
The Drug Quality and Security Act, H.R. 3204, will let compounding pharmacies that produce drugs for human medicine in the absence of a prescription voluntarily register with the Food and Drug Administration as “outsourcing” facilities, which then will be subject to requirements for inspection, drug production reporting, and adverse event reporting.
While the legislation will directly affect only drugs compounded for human medicine, many of the compounding pharmacies that could submit to the added requirements also compound drugs for veterinary medicine.
The legislation also will not affect prescriptions or prescription practices in veterinary medicine.
State governments are responsible for routine regulation and oversight of compounding pharmacies, which generally do not need to register with the FDA or tell the agency what drugs they are producing, according to the FDA. But the agency has extralabel drug use rules that apply to compounded pharmaceuticals.
Michigan Rep. Fred Upton introduced the bill in Congress Sept. 27, and it passed in the House the next day and in the Senate Nov. 18. President Barack Obama signed the bill Nov. 27.
Rep. Upton said in an announcement after the bill passed the Senate that his legislation would prevent a repeat of the fungal meningitis outbreak that began in 2012 and caused infections in at least 751 people, killing 64. The Centers for Disease Control and Prevention indicated the outbreak of meningitis and other infections occurred among people who received injections of a contaminated steroid product from a compounding pharmacy.
Michigan had 264 of the infections, with 19 deaths, the highest of each among the 20 states with infections, according to the CDC. Upton’s announcement said three of the deaths occurred in his district.
In addition to creating the outsource facility designation, the legislation will require that the federal government receive notification from state boards of pharmacy describing disciplinary actions against compounders, drug recalls involving compounders, or concerns that a pharmacy may be violating the federal Food, Drug, and Cosmetic Act.
It also will establish requirements to help trace compounded drugs through supply chains, including information to be provided during distribution and on packaging.
Upton’s announcement indicated the legislation will strengthen the prescription drug supply chain, protect against counterfeit drugs, and eliminate bureaucracy.
A spokesman for the International Association of Compounding Pharmacists provided a statement that the legislation would not prevent a crisis similar to the fungal meningitis outbreak, and the organization doubted the pharmacy that produced the contaminated steroids would have voluntarily registered as an outsourcing facility.
No ruling coming in compounding dispute (Dec. 1, 2012)