February 1, 2017

Compounding pharmacies express frustrations from incomplete FDA guidance

Some pharmacists are expressing frustration over the time it is taking for the FDA to finalize its guidance on various areas involving compounded drugs, according to a November 2016 report from the U.S. Government Accountability Office.

Nearly a quarter of stakeholder organizations said it is difficult for pharmacies to move forward without final guidance from the FDA about which drugs it considers difficult to compound. Adding drugs to a bulk drug list exempts them from stringent provisions of the Federal Food, Drug and Cosmetic Act and means that pharmacies can use those drugs as active ingredients in compounded medications.

Meanwhile, 30 state pharmacy regulatory bodies reported that their members had concerns over the availability of office-use compounding. The FDA’s draft guidance requires a prescription for compounded drugs under Section 503A of the FD&C Act. This means that traditional pharmacies cannot supply common compounded drugs, which are often kept as stock, to hospitals or physician’s offices.

The draft guidance is inconsistent with state laws that allow office compounding without a patient prescription. Georgia’s Board of Pharmacy limits office-use compounding to outsourcing facilities, but survey respondents in 27 states reported that their state allows office-use compounding.

FDA officials are attempting to balance access to medication with its obligation to keep patients safe from poorly produced drugs, according to the GAO report. The prescription requirement is meant to differentiate compounding by traditional pharmacies from conventional manufacturing and outsourcing facilities.

The FDA is still finalizing a memorandum of understanding between states and the federal agency and working with the National Association of Boards of Pharmacy to curtail the amount of compounded drugs that are available from another state. Under section 503A, only 5 percent of the drugs produced by a traditional pharmacy can be sold outside of the state where the pharmacy is registered unless a state signs the MOU. The draft MOU, which was first published in February 2015, would restrict interstate distribution of compounded products by traditional pharmacies to less than 30 percent of its overall drug production in a calendar month.

Some pharmacies close to state borders worry that the new compliance measure will decrease sales and inconvenience customers. If a pharmacy has a large number of customers from a neighboring state, it is logical to sign the MOU in order to distribute up to 30 percent of its product, rather than the five percent allowed without agreeing to the MOU.

FDA officials say soliciting feedback and evaluating comments — they received 3,000 comments on the agency’s draft MOU — are time-consuming steps that will ultimately result in better guidance.

Overall, most states say they are satisfied with their communication with the FDA and other state regulatory bodies. About three quarters of the states have participated in intergovernmental meetings or other FDA-sponsored activities.

As FDA guidance continues to evolve, it’s crucial for compounding pharmacies to stay up-to-date on the issues. For questions about compliance with state and federal regulations, contact Hasson Law Group.

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