January 18, 2017

GAO report shows how states are inspecting compounding pharmacies

Most states, including Georgia, inspect compounding pharmacies and take action when something is amiss, according to a November 2016 report from the U.S. Government Accountability Office.

Compounding pharmacies are inspected by states to obtain a license, in response to a complaint or as part of a reoccurring safety check. Forty-two states reported inspecting all licensed pharmacies operating in their state, and six states said that they had inspected some resident pharmacies.

The frequency of inspections varies by state. Twenty-one states said that they inspect pharmacies annually. Eleven states inspect compounding pharmacies at least once every two years.

Each state determines how its inspections are conducted. More than a third of states reported problems meeting inspection time frames, partly due to a lack of pharmacy inspectors. The number of state pharmacy inspectors reported in the survey ranged from zero to 138. The state that reported no pharmacy inspectors said that the state’s five pharmacy board members conduct the inspections. Most states require an inspector to have a pharmacist’s license and nearly half of the states require several years of work as a pharmacist. Inspectors for compounding facilities in 21 states need to complete a specialized training program.

In the GAO survey, states cited limited resources as a reason for not meeting inspection mandates. One comment from a state respondent said that 46 inspectors were responsible for inspecting more than 1,000 sterile compounding pharmacies in that state every year. Another respondent said that the priority is to always inspect sterile compounding pharmacies with its small staff.

If the inspection turns up a violation, states have a variety of enforcement actions they can use to compel the pharmacy to comply with the law. The most frequent enforcement action, used by 45 states, is suspending a pharmacist’s or pharmacy’s license. Six states reported suspending pharmacy licenses in 2015.

Monetary fines, used by 41 states, are another common deterrent. In 2015, 12 states imposed fines on pharmacies, with the number of pharmacies fined in each state ranging from one to 73.

Other measures include warning letters or cease and desist orders that restrict a pharmacist’s license so they cannot compound sterile drugs. States may also give simple reprimands.

Nineteen states can recall compounded drugs if they find a pharmacy has violated state law. Three states issued a drug recall in 2015.

State pharmacy regulatory bodies in 50 states, the District of Columbia, Guam, Puerto Rico, and the U.S. Virgin Islands were surveyed, and all but four completed the GAO survey.

In addition to state inspections, federal inspections of compounding pharmacies may be performed for cause, follow-up and surveillance. The Hasson Law Group has specific recommendations for compounding pharmacies facing a state or federal inspection. Learn more here.

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