Jun 5, 2017 - implementation and enforcement of the Drug Quality and Security Act, as well as those of other stakeholder
The International Academy of Compounding Pharmacists Comments to FDA Listening Session on DQSA Implementation June 5, 2017
Introduction: Thank you for the opportunity to speak today. My name is David Pore and I am an attorney for the International Academy of Compounding Pharmacists (IACP). IACP is an association representing more than 3,600 pharmacists, technicians, students and members of the compounding community who focus on the specialty practice of compounding pharmacy. I appeared before this panel a year ago and gave remarks that were very similar to the remarks I will give today. While we appreciate the invitation to be here, we are frankly disappointed and frustrated that the FDA has, to date, largely ignored our comments on the agency’s implementation and enforcement of the Drug Quality and Security Act, as well as those of other stakeholders and those of the United States Congress. Unfortunately, despite near unanimity in the input to the agency by the pharmacy community and the community of medical providers who rely on compounded medications to treat their patients, the FDA continues to misinterpret the DQSA in a way that is jeopardizing patient access to critical compounded medications. It is alarming that the FDA has, in implementing and enforcing the DQSA, chosen to ignore clear congressional intent expressed by multiple members of both parties in both chambers during passage of the DQSA in 2013, multiple stakeholder letters and other input expressed at these listening sessions an other forums, letters from Congress, questions for the record submitted during congressional hearings, directives in the reports accompanying the bills funding the agency for the last two fiscal years (FY16 and FY17), and in some cases, the plain language of the statute. IACP shares the FDA’s commitment to protecting public health and safety; however, in pursuing that goal, the agency has overstepped the regulatory authority given to it by Congress and begun regulating and inspecting state-licensed and compliant compounding pharmacies as if they were drug manufacturers. It is inappropriate for the FDA to continue to use non-binding guidance documents to substitute the agency’s desired regulatory authority over compounding pharmacies for the authority actually given to the agency by the Congress in Sections 503A and 503B of the FDCA. Two weeks ago, 65 members of the US House of Representatives sent the FDA a letter expressing strong disappointment that the agency, in issuing a final Guidance for Industry (GFI) entitled “Prescription Requirement under 503A of the FDCA” has again completely ignored previous congressional letters and clear directives on these issues in recent FDA funding bills. The letter, signed by many of the very members who were involved in the drafting of the DQSA, asks that the final GFI be rescinded and that the FDA issue a new proposed rule that is consistent with the statutory language and clear congressional intent of the FDCA as amended by the DQSA. IACP joins these Members of Congress in their hope that newly confirmed FDA Commissioner Gottlieb will re-evaluate the agency’s policies on compounding pharmacies and
work with stakeholders through the rulemaking process to develop new policies that adhere to congressional intent and plain language of the DQSA and that better balance public safety with patient access to needed compounded medications. I will now speak briefly on three of the policy positions the FDA has taken that are not consistent with the statutory language or congressional intent of the law.
Office-Use Compounding: The vast majority of state pharmacy practice acts and related state regulations authorize some form of office-use compounding. IACP and multiple other organizations representing pharmacists and the providers who prescribe and treat their patients with compounded medications have provided the FDA with input as to the medical necessity of the administration of compounded medications by providers in office or clinical settings. The Congress has weighed in on multiple occasions and in multiple ways (including statements in the congressional record, letters, QFRs and directives in appropriations bills) to remind the FDA that the DQSA was not intended to prohibit office-use compounding and does not preempt state laws that authorize office-use compounding. Yet, the FDA continues to ignore stakeholders and the Congress and substitute the agency’s desired regulatory authority over compounding pharmacies for the authority actually given to the agency under the law. Stakeholders and the Congress have repeatedly reminded the FDA that in 2012, prior to passage of the DQSA, the agency circulated a draft compliance policy guidance that would have allowed for office-use compounding under 503A of the FDCA, with some restrictions. The relevant statutory language of 503A was not changed by the DQSA, yet the agency now takes the position that the same statutory language prohibits office-use compounding by 503A pharmacies under all circumstances, even where expressly authorized by state law. The FDA’s assertion that the creation of 503B “outsourcing facilities” that are authorized to compound without receipt of a patient-specific prescription eliminates the need for 503A officeuse compounding is inaccurate. Outsourcing facilities are operations subject to cGMP standards that require manufacturer-level testing under those standards. This testing is extremely expensive and can take weeks or months to complete, a timeline that often does not meet the needs of providers treating patients in office or clinical settings. We have provided, on multiple occasions, examples of compounded medications needed in office and clinical settings that are not available from outsourcing facilities due to factors related to time and economics. We join the 65 Members of Congress who recently wrote the FDA in asking that the final GFI be rescinded and that the agency work with stakeholders to develop a proposed rule that authorizes office-use compounding by 503A compounding pharmacies in a way that protects both patient safety and patient access to the compounded medications they need.
Definitions of the terms “Distribute” and “Dispense”: IACP and numerous other stakeholders, as well as the Congress, have weighed in with strong objections to the sample Memorandum of Understanding (MOU) between states on the subject of interstate “distributions” of compounded medications and the FDA’s attempt to expand the agency’s regulatory authority by re-defining the term “distribution” to include that patientspecific “dispensing” of compounded medications over state lines. Now, in the final GFI on the prescription requirement under 503A, the FDA has again inappropriately attempted to redefine these terms and assert regulatory authority of the interstate “dispensing” of compounded medications, the very essence of the traditional practice of pharmacy, and something Congress never intended. These terms have well-established definitions in federal statutes, in the CFR and in most if not all of the states’ pharmacy practice acts. It is inappropriate for the FDA to attempt to assert regulatory authority over the practice of pharmacy in a way that Congress never intended by redefining key terms in a guidance document. We join other stakeholders and the Congress in asking that FDA rescind the GFI and issue a proposed rule and final MOU that treats the distribution and dispensing of compounded mediations as the distinct activities that they actually are under the statute. Inspection Standards for 503A Pharmacies: Lastly, IACP would like to raise the issue of FDA inspecting 503A compounding pharmacies under cGMP standards rather than under USP or other applicable pharmacy inspection standards adopted by state law or regulation. Often, FDA will cite a pharmacy for not getting patientspecific prescriptions before compounded medications leave a pharmacy and assert that the pharmacy has therefore lost its exemptions from cGMP standards, even when inspecting pharmacies in states where office-use compounding is specifically authorized by state law and/or regulation. FDA also routinely attempts to deny compounding pharmacies the records exemptions provide in 21 USC 374 (a)(2)(A) without citing any statutory authority to do so. IACP asks that when inspecting state-licensed 503A pharmacies, the agency work with state boards of pharmacy and use inspectors trained in USP or other applicable state pharmacy inspection standards. We ask that the FDA cease using the agency’s misinterpretation of misapplication of prescription requirement under 503A as a pretext to conduct pharmacy inspections under manufacturer standards. As the Congress has attempted to remind the agency on multiple occasions, compounding pharmacies are not drug manufacturers, and should not be inspected under cGMP standards absent a clear showing of violations of 503A of the FDCA. Conclusion: I again thank the FDA for the invitation to provide input on behalf of IACP today and look forward to working with Commissioner Gottlieb and the FDA staff on revising these policies in a way that protects both public safety and patient access to compounded medications.
