On House floor, Carter speaks out against FDA compounding restrictions

Agency’s draft guidance would prohibit most office-use compounding

Rep. Buddy Carter (R-GA), BSPharm, on April 28 delivered an impassioned speech on the House floor in protest of recent FDA draft guidance on compounding that essentially would prohibit pharmacies and hospital and health-system compounders from office-use compounding in most circumstances. Carter is the only pharmacist Member of Congress.

In his speech, Carter said that Congress never had any intention to limit office compounding when it passed the Food, Drug, and Cosmetic Act (FD&C). He then criticized the FDA guidances for encroaching on states’ authority to regulate the practice of pharmacy. (The agency also released draft guidances for hospital and health-system compounding and facility definition under Section 503B.)

“The [Obama] administration continues to ignore the intent of Congress or blatantly fails to enforce laws already on the books. The most recent example of this overreach is [FDA’s] reversal of its interpretation of office-use compounding,” Carter told pharmacist.com. “This is a direct attack on small community pharmacy compounding because it will subject small community pharmacies to higher standards than Congress intended under the Drug Quality and Security Act. We cannot allow the administration to react to bad actors in a manner that overreaches their authority and harms hard-working Americans.”

For the most part, the draft guidance on the prescription requirement under Section 503A of the FD&C Act prohibits non–patient-specific office use of compounds. Anticipatory compounding is permitted prior to prescription only when the compounding is based on a history of the pharmacist or physician receiving valid prescription orders for the compounding of a human drug product and the orders have been generated solely within certain established practitioner–patient relationships. The exemption for anticipatory compounding includes other limitations and record-keeping requirements.

Carter said in his speech that, in passing the Drug Quality and Security Act, which modified the FD&C Act by clarifying traditional compounding (section 503A) and creating a new section 503B for outsourcing facilities, Congress intended that only outsourcing facilities, and not traditional compounders such as licensed pharmacies, would be subject to FD&C inspection standards.

He believes that the rules ignore or distort congressional provisions in FD&C. In the speech, Carter described the case of an anesthetic for a skin cancer test—“now the doctor has to write a prescription, have the patient go to the pharmacist, get the prescription filled, and schedule another appointment with their dermatologist before checking to see if they have skin cancer”—as an example of why he objected to the FDA draft guidance.

He believes the draft guidance misrepresents Congress’s intentions for 503A pharmacies and that the restrictions harm patients by belaboring the process of getting treatment.

Carter delivered the speech during a special order on executive overreach convened by Rep. Ted Yoho (R-FL).