Pharmacists Benefit as Congress Confronts FDA Draft Guidance on Office-Use Compounding

Pharmacists Benefit as Congress Confronts FDA Draft Guidance on Office-Use Compounding

i-cadeceusYou’re not alone if you feel the effect of acute twisted neck, what with all the head-turning disagreement between the FDA and Congress over compounding. In fact, you’re in good company. In February, the International Academy of Compounding Pharmacists and the Professional Compounding Centers of America were quoted as saying that the FDA had voiced support for office-use compounding. By April, the FDA proved the opposite was true. The FDA intends to block office-use compounding, but the Congressional Appropriations Committee pushed back to stop this egregious overreaching by the FDA. While compounding pharmacists have good reason to hope, hold onto those cervical collars—the volleying isn’t over yet.

FDA Draft Guidance on Compounding

When the FDA issued draft guidance reports for the compounding industry in April 2016, it officially took one giant leap beyond its regulatory boundaries. That’s easy to do when you change the rules. It began when the FDA declared its intent to redefine “distribution” to mean “dispensing.” Where they once only had authority to regulate pharmaceutical distributors, with one quick parsing of words, FDA oversight suddenly extended to independent pharmacies. From there, the next step was easy—the FDA issued three draft guidance documents to clarify how the agency intends to implement section 503A of the Federal Food, Drug and Cosmetic Act (FDCA). Key provisions that stifle compounding pharmacists include:1

Valid prescription: Drugs can only be compounded and dispensed after the receipt of a valid prescription, which must identify the patient and be written by a licensed physician or other state licensed practitioner. Even if you’re located in a state that permits prescriptions to be written without a specific patient’s name, the new regulations say those prescriptions are now invalid.

Limits on anticipatory compounding: Compounding drugs before receipt of a valid prescription is only allowed under specific requirements:

  • Established relationship: Anticipatory compounding is only allowed if you have a history of receiving valid prescription orders for the drug product. These prescriptions must be within the context of an established relationship between the compounding pharmacist and the patient or the prescriber.
  • Limited quantities: Prior to receiving a valid prescription, you can’t stock more than a 30-day supply of the drug product. The amount is based on the typical 30-day supply from valid prescriptions received during a selected period.
  • Record keeping: Compounding pharmacists must keep records of the calculations used to determine the amount of their 30-day supply.

No third-party office-use compounding: Third parties that source compounded drugs for office use can only continue to do so through a 503B-regulated outsourcing facility. You have the option of registering your pharmacy as a 503B outsourcing facility as created by the Drug Quality and Security Act (DQSA).

Hospital compounding: Pharmacies that fall under section 503A—and that are part of a hospital or health system—have a little leeway. They’re allowed to distribute drugs without a prescription as long as the compounded products go to facilities that are owned by the same system and located within a 1-mile radius of the compounding pharmacy.2

House Appropriations Committee Changes the Game

The new FDA regulations aren’t final yet, so the House Appropriations Committee has intervened in time to make a significant difference. For starters, the Consolidated Appropriations Act of 2016 (the Omnibus bill), which funds the FDA through September 2016, didn’t approve additional funding requested by the FDA to target pharmacy compounding and implement DQSA. But the report from the Appropriations Committee, which is submitted with the Omnibus bill, tells the deeper story—a story that gives compounding pharmacists reason to hope for relief from the FDA’s proposed restrictions.

The Committee didn’t stifle their criticism of the FDA, noting the serious overreaching of the FDA’s authority, the urgent need to protect patient access to compounded medications, and their grave concern over prohibiting office-use compounding. More specifically, the Committee stated the “FDA has interpreted provisions of Section 503A of the FDCA in a manner inconsistent with its legislative intent, and with the agency’s own previous intentions,” reported the International Journal of Pharmaceutical Compounding. In fact, Congress intended for office-use compounding to be allowed—as a result:

  • The Appropriations Committee directed the FDA to issue new guidance within 90 days that allows compounding pharmacists to continue office-use compounding.
  • The Committee also said that changing “distribution” activities to include “dispensing” does not adhere with Congressional intent.

Compounding Pharmacists Have a Voice that Counts

The language used by the Appropriations Committee was developed in collaboration with the International Academy of Compounding Pharmacists (IACP) and legal experts representing the interests of compounding pharmacists on Capitol Hill. The IACP continues to work for you as the FDA must allow stakeholder input. As an independent pharmacist, you can affect the future by adding your voice to the campaign. Whether you contact the IACP to weigh in on the FDA’s actions or you contact your local senators and representatives, you have a window of opportunity to influence the FDA’s proposed compounding regulations and protect your ability to properly care for patients.3

Pharmaceutica North America supports compounding pharmacists by providing the latest news that affects your business and through our dedication to providing the highest-quality pharmaceuticals. Contact us today to talk about how we can collaborate to meet your compounding needs.

Show 3 footnotes

  1. “FDA Releases Guidance on Pharmacy Compounding, But the Future Is Anything but Clear,” May 2016, http://www.lexology.com/library/detail.aspx?g=aefc6c71-1aa7-4f9c-a295-c06107a16292
  2. “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry, April 2016, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496287.pdf
  3. “How to Contact Your Elected Officials,” 2016, https://www.usa.gov/elected-officials
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