miércoles, 30 de marzo de 2016

FDA Law Blog: Compounding the Dilemma over the Permissibility of Office Use Compounding: Congressman Requests Answers to Questions from HHS Secretary Burwell

FDA Law Blog: Compounding the Dilemma over the Permissibility of Office Use Compounding: Congressman Requests Answers to Questions from HHS Secretary Burwell

Posted: 29 Mar 2016 08:01 PM PDT
By Karla L. Palmer –

On Tuesday, March 15, 2016, HHS Secretary Burwell testified before the House Education and the Workforce Committee, during which Representative Buddy Carter (R. Ga.), who is a pharmacist, asked Secretary Burwell about office use compounding. Representative Carter expressed his concern about FDA’s interpretation of legislative intent dealing with “office use only” compounded medications. He addressed the fact that office use compounding, where the physician has the ability to use the medication on patients in the doctor’s office, has traditionally been permitted in several states, and inquired about the status of FDA guidance on the same. Secretary Burwell stated that FDA does not have guidance preventing office use compounding, and that such compounding should be occurring, adding confusion to whether office use compounding is indeed currently permitted. Representative Carter stated that Congress is looking for guidance on this issue, as it involves patients getting the care they need. The Secretary responded she would like input on office use compounding as FDA formulates its guidance on its permissibility. See the clip of the relevant hearing testimony here.   

Following up on Secretary Burwell’s testimony, Representative Carter sent a letter dated March 22, 2016 to the Secretary, in which he further addressed his questions to her about office use compounding relating to physician offices, and the lack of guidance by FDA. He noted her response to his questions “indicating that there is nothing preventing a 503A pharmacy from compounding for ‘office use’ purposes failed to address FDA guidance that has yet to clarify that 503A pharmacies will be exempt from individual prescription requirements.”

Representative Carter added that section 503A pharmacies are currently “being regulated under Good Manufacturing Practices (cGMP) standards rather than U.S. Pharmacopeia (USP) Convention standards, which have been the standards for 503A pharmacies for years.” He also stated that he is concerned that “FDA’s application of DQSA section 503A requirements to 503A pharmacies in the same manner as large outsourcing facilities is placing undue burden on 503A pharmacies and the patients they serve.” (Recent Form 483s of traditional pharmacies posted on FDA’s website highlight that FDA is routinely holding section 503A pharmacies to cGMP during inspections since at least spring 2013.) Stating that pharmacies that produce small amounts of compounded medications in advance of receiving individual prescriptions, which practice in states that authorize “office use” compounding, should not be the focus of FDA’s oversight; such oversight “by FDA of 503A pharmacies is unreasonable and was not Congress’ intent during passage of DQSA.” 

In order to address concerns, Representative Carter requested a response from the Secretary to the following questions:

  1. It is my understanding that FDA is currently working on guidance to clarify that 503A pharmacies, who are regulated by State Boards of Pharmacy, will be exempt from DQSA requirements when participating in "office-use" compounding. When can we expect FDA to release this guidance?
  2. For years, 503A pharmacies have operated under the standards contained in the U.S. Pharmacopeia (USP) Convention for sterile and non-sterile compounding. What prompted FDA to begin inspecting these 503A pharmacies under current Good Manufacturing Practices (cGMPs) as opposed to USP standards?
  3. The FDA has begun inspecting state licensed 503A pharmacies using cGMP standards rather than USP standards or other applicable pharmacy inspection standards adopted by state law or regulation in the state where the pharmacy is licensed. Section 105 of DQSA states that any finding by the FDA must be turned over to the appropriate State Board of Pharmacy for review and consideration of corrective actions to bring the pharmacy back into compliance with state law. What authority, with clear congressional intent to state otherwise, does FDA have to inspect 503A pharmacies with cGMPs when federal oversight of 503A pharmacies was never the intent of Congress?
Representative Carter requested responses to the above questions within ten business days of the date of the letter (i.e., by April 5, 2016). Answers to the three questions may have a significant impact on the thousands of compounding pharmacies across the United States that are grappling with not only the permissibility of office use compounding but also the propriety of FDA’s dramatically increased scope of the Agency’s inspections of compounding pharmacies. Will the Secretary respond? We will let you know what happens next. Stay tuned.

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