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New Legislation Aims To Roll Back FDA Guidance Restrictions On Office Use

For the twenty-third year, during the early summer months, the International Academy of Compounding Pharmacists (IACP) held its Compounders on Capitol Hill meeting in Washington, D.C. from June 10-13, 2017. Keith S. Hasson, founder of the Hasson Law Group, attended the meeting as the guest of two of his long-time clients in the compounding industry. During and after the meeting, Keith has reviewed and discussed with IACP members two dramatic legislative changes that deserve the support of compounders throughout the Nation. The legislation was introduced, and all compounding pharmacists in Georgia and around the country need to review it and, hopefully, get busy supporting it.

In the four years since passage of the Drug Quality and Security Act (DQSA) of 2013, the compounding industry and the FDA have struggled to rationalize and accommodate certain of the industry’s decades-long practices with the DQSA’s laudable goal of assuring patient safety. In several regulatory areas, IACP believes the FDA appears to have misinterpreted the Congress’ intent in 2013 and certain administrative course corrections seem to be necessary. However, in two related, but functionally different, areas, critical to the sustainability and profitability of compounders, IACP believes the FDA’s informal but public “guidance” documents have seriously overstepped the boundaries established by the Food and Drug Act, as amended by the DQSA.

First, the FDA’s interpretation of the type of “distribution” prohibited by the DQSA–sometimes referred to as the “Individual Patient Prescription” requirement—has substantially curtailed compounders’ ability to prepare, in bulk, patient-specific medications in advance of their need for use, so-called Anticipatory Compounding.. IACP and its public advocacy partner, the Partnership for Personalized Prescriptions (P3), have obtained the support of sixty-five (65) Members of the United States House of Representatives for legislation that will limited funding of the FDA if it seeks to finalize or enforce any informal “guidance,” administrative rule, or memorandum of understanding that expands the DQSA’s definition of drug “distribution” to include the dispensing of patient-specific compounded medications. IACP’s and P3’s strategic approach is to use the “power of the purse” to restrain the FDA on this important issue.

Second, the FDA’s attack on the long-standing preparation of “Office Use” medications that have been historically provided to patients in their physicians’ offices, is to be rolled back by the same legislative approach. The proposed legislation will limit funding for the FDA to enforce any limitation on “Office Use” compounded medications, so long as the compounder is a State licensed pharmacy, who is compliant with applicable State regulations, and is doing business in a State in which relevant State law allows “Office Use” medications to be dispensed.

On May 23, 2017, the sixty-five House Members supportive of these changes wrote to then FDA Commissioner Scott Gottlieb. After the appointment of new Commissioner, Dr. Robert M. Califf, this group of 65 Members wrote again. On June 13, 2017, during IACP’s annual meeting, Congressman Morgan Griffith (R.-Virginia) and Congressman Henry Cuellar (D.-Texas), in a demonstration of bi-partisan political support, formally introduced H.R. 2871, The Preserving Patient Access to Compounded Medications Act of 2017. We are attaching the “one-pager” on this legislation, together with copies of the Congressional letters to the FDA Commissioners. IACP asked its membership to contact their Representatives about co-sponsoring the House Bill.

Most importantly, IACP recommends all compounding pharmacists and supporters contact their two United States Senators. Here is the Senatorial contact information for Georgia:

Honorable Johnny Isakson
Washington D.C. Office
United States Senate
131 Russell Senate Office Building
Washington, DC 20510
Tel: (202) 224-3643
Fax: (202) 228-0724

Honorable David Perdue
Georgia State Office
3280 Peachtree Road, N.E.
Suite 2640
Atlanta, Georgia 30305
(404) 865-0087
(404) 865-0311

In addition to the Office Use and Anticipatory Compounding issues, the FDA has attempted to regulate other activities described below. H.R. 2871 will attempt to remedy all of the issues described below.

In short-hand form, the essential issues (“talking points”) addressed by the proposed legislation include:

1. “Distribution” is not “dispensing.” The FDA its “Memorandum of Understanding” under section 503A of the Food and Drug Act, addresses the distinction between “dispensing” and “distribution.” The FDA was allowed, in the DQSA, to regulate “distribution,” but not “dispensing.” The FDA’s Memorandum of Understanding swallows the latter with the former, but that was not what the Congress intended. The FDA should not be allowed to prohibit the “dispensing” of compounded drugs over State lines, so long as all of the other requirements of section 503A are met.

2. “The right drug at the right time.” When a commercially manufactured drug is not appropriate for a specific patient for specific reasons, a compounded drug may fill the need, a need that could be the difference between life and death. In order to fill this need, a compounding pharmacist may prepare a batch of the medication in anticipation of subsequently patient-specific prescriptions. This is known as “office use.” Similarly, a prescribing physician may maintain such a batch in the office, if the use of a traditional prescription would be impractical or even unsafe. The FDA’s draft guidance of April 15, 2016 challenges these long-standing office use practices. The proposed legislation would, however, allow anticipatory preparation of these types of medications, based on previous valid prescription orders or on an established history between the prescribing physician, the patient, and the compounder.

3. “The FDA should leave the animals alone.” The FDA has proposed industry guidance that applies sections 503A and 503B of the Food and Drug Act to animal health. The legislation limits the regulation of compounders to preparation of drugs intended for human use. Any such involvement of the FDA should be based on relevant veterinary practices.

4. Drug “compounding” is not drug “manufacturing.” As an overall matter, the proposed legislation rolls back FDA initiatives that reflect a philosophy that compounding pharmacists are essentially drug manufacturers (“Big Pharma”). This reflects a fundamental misunderstanding of the role and practices of compounders.

5. “The Statute Means What It Says and Says What It Means, about Weight Loss Medications.” The Food and Drug Act, as amended in 2013, makes it clear that the compounding of diet “drugs” and dietary supplements is proper if done in accordance with any National Formulary monograph or any United States Pharmacopeia monograph. The public prescriptions of these private self-regulating bodies are sufficient.

6. Conduct of FDA Inspections. Perhaps the most important issue to be addressed in this legislation is the apparent intent of the FDA to conduct all inspections of compounding pharmacies as if they are members of Big Pharma and must comply with the FDA’s ”Good Manufacturing Practices” with respect to sterility. IACP believes that State inspection and regulation is effective and sufficient. Compounding pharmacists are small business people. They will never have the capital necessary to convert their small, but well-run, businesses to miniature versions of Big Pharma.

7. “No Regulation Without Representation.” IACP supports reformation of the Pharmacy Compounding Advisory Committee (PCAC). This organization, mandated by the 2013 amendment, could be very effective. It requires membership on the Committee of a compounding industry representative. Unbelievably, however, the industry representative is not allowed to vote on PCAC’s recommendations, which will be critical to whether compounding pharmacists will flourish under the FDA’s new regulatory regime or be crushed by the desire of Big Pharma to keep the field for themselves.

8. “Safety is best assured when patient access to quality products is insured.” In general, State laws have been effective and are sufficient. Moreover, to the extent that the FDA is allowed to impact compounding pharmacies, it must not be allowed to use its favorite forms of communication—the use of so-called “guidance.” The FDA must be required to follow the Administrative Procedures Act, which allows full input from the compounding industry and related supporting trade groups as part of the formal rule-making process; a process which the FDA has, up until now, circumvented by simply issuing “guidance” documents.
You can obtain more information about IACP’s efforts through its website at If you have questions about how this proposed legislation might affect your business, or about FDA inspections, please contact the firm at [email protected].

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    Hasson Law Group LLC

    The Hasson Law Group, LLP, is an Atlanta, GA law firm dedicated to two principal practice areas: winning high stakes disputes in the areas of business litigation, insurance recovery, and complex criminal defense, and tax, corporate and regulatory law mechanisms affecting family businesses, tax-exempt organizations and the individuals who support or serve them.

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