Posted: 21 Nov 2016 11:23 AM PST
By Karla L. Palmer –
The Government Accountability Office (GAO) released a detailed Report last week addressing FDA’s efforts to regulate compounding since Congress’ passage of the Drug Quality and Security Act in November 2013. U.S. Gov’t. Accountability Office, GAO-17-64, FDA: FDA Has Taken Steps to Implement Compounding Law, but Some States and Stakeholders Reported Challenges (2016) [hereinafter “Report”]. To inform its conclusions, among other activities, the GAO interviewed and surveyed state regulatory pharmacy bodies in 50 states and U.S. territories, reviewed documents, interviewed dozens of pharmacy stakeholder organizations, reviewed relevant laws, interviewed FDA officials, and reviewed FDA data on compounding inspections and regulatory actions. Summaries of data and information collected concerning various drug compounding legal issues and regulatory activities by states and FDA are dispersed throughout the numerous charts in the Report.
Although somewhat difficult to follow (it would be more helpful if FDA instead detailed in an appendix, for example, exactly what particular states required of compounders and how they are regulated), the Report itself points out that FDA and states need more coordination on regulatory activities affecting compounding. These regulatory activities affect thousands of compounding physicians and pharmacies that engage in compounding on a much needed, daily basis. The GAO describes the various settings in which compounding occurs; however, the reader is quickly left with impressions of confusion concerning how any particular state regulates compounding. Not surprisingly, the Report demonstrates that state compounding laws and regulations are quite inconsistent not only among the states, but also among the states and FDA. Some highlights:
(1) FDA and states surveyed note that compounding by physicians - permitted under Section 503A - is not necessarily regulated by state pharmacy compounding laws. Only 9 states reported having laws or regulations specific to compounding by physicians and non-pharmacies; most medical boards consider compounding to be part of the practice of medicine. (Report at 24-27).
(2) State laws, regulations and other policies addressing sterile compounding vary greatly across those states surveyed. However, the Report points out various enforcement actions states may take (from fines to licensing suspension). State data is not necessarily tracked concerning cases involving compounded medications. States also do not track volumes of drugs compounded.
(3) While most states are satisfied with FDA’s communications with states concerning compounding matters, 23% of states surveyed report they were not necessarily satisfied. Among other comments, one state commented that FDA was making insufficient progress in providing guidance regarding FDA’s intended regulatory approaches, and FDA seemed burdened with “red tape.” (Report at 33-36).
(4) FDA’s risk models used to determine what facilities to inspect do not consistently collect reliable and timely information on inspections and enforcement actions, including correct inspection classifications as either official action indicated, voluntary action indicated, or no action indicated from the results of the inspection. (Report at 42-43).
(5) On the general data collection front: From May 11, 2012 to April 22, 2016, FDA conducted 265 inspections of 210 facilities that are not outsourcing facilities. It issued 228 FDA Form 483s, 81 warning letters, 72 voluntary recalls, 31 state referrals, and requested 1 regulatory meeting. The Agency conducted 75 inspections of 51 outsourcing facilities (it tries to inspect outsourcing facilities within 2 months of registration); these have resulted in 24 facilities have received warning letters, one untitled letter, 14 voluntary recalls, and obtained two injunctions. (Report at 44-47). The Report itself does not mention the number of Form 483s issued to outsourcing facilities (but this information is available on FDA’s outsourcing facility page because it posts them).
(6) Some stakeholders commented that the amount of time FDA has taken to finalize guidance and other documents is “challenging” and creates uncertainty on how compounders (both outsourcing facilities and traditional) move forward under the DQSA’s undefined regulatory rubric. Among other issues, they cite FDA’s delays in finalizing the “difficult to compound” list and the Memorandum of Understanding (MOU) between states and FDA that would govern interstate distribution/dispensing of compounded products. The Report specifically notes that several stakeholders are concerned with the proposed MOU’s interchangeable (and inexplicable) definition and use of the terms “dispensing” and “distribution” of compounded drugs to be included in the proposed 30% interstate limit calculations. (Report at 47-48)
(7) States and stakeholders also expressed concerns about differences in inspection protocols between states and FDA. Compounding pharmacies have been floating this complaint since FDA first dramatically increased the number of pharmacy inspections back in late 2012 (and holding the sites to a cGMP standard instead of traditional state pharmacy standards that generally encompass USP <795> and <797>). GAO notes that FDA has attempted to clarify its inspection protocol, through release of a notice changing inspection procedures on August 1, 2016. (FDA, Notice (Aug. 1, 2016)) (see our previous post here). FDA’s August 2016 notice describes a “preliminary assessment” that FDA makes upon commencement of a pharmacy inspection as to whether the pharmacy should be held to FDA’s cGMP regulations for manufacturers or whether it should be entitled to Section 503A’s exemption from cGMP. The outcome depends on FDA’s determination whether, among other things, the pharmacy is engaging only in patient specific compounding, and the more complicated determination of whether the pharmacy is violation of other FDCA provisions (i.e., compounding under insanitary conditions). It would be interesting to know how many pharmacies, inspected since August 1, 2016, have been held to cGMP versus the appropriate state/USP standards. 797>795>
(8) Several states and stakeholders report concerns related to FDA’s responsibilities in its implementation of the DQSA which may affect the availability of compounded drugs for office use. States and stakeholders note that the DQSA’s prohibition on office use compounding is inconsistent with laws in 27 states that currently permit office use compounding. Respondents in 23 states reported concerns related to access to compounded medications for patients with a medical need for drugs. This is because, for certain drugs for which there is not a great demand yet are compounded for office use, outsourcing facilities will not undertake to compound them (presumably because the cost is too great given the limited demand, and thus limited profit). If compounding pharmacies cannot compound drugs under Section 503A, patients could lose access to needed drugs. (Report at 48-49).The Report does not address how many traditional compounding pharmacies still engage in office use compounding notwithstanding its prohibition in Section 503A versus 27 states’ legal permission of office use compounding. The HHS responded to the GAO’s findings. FDA stated it has stepped up efforts to increase collaboration with states, and that it plans to take or has taken action concerning other issues, such as compounding by physicians, access to compounded drugs (i.e., office use).
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