Before the U.S. Senate approved new compounding legislation, senators made statements clarifying for the Food and Drug Administration (FDA) that the bill essentially preserves state board of pharmacy authority over the typical compounding work done by independent community pharmacies.
In particular, U.S. Senators Tom Coburn (R-Okla.) and John Boozman (R-Ark.) inserted extensive remarks on the subject into the Congressional Record history of the debate and approval of H.R. 3204, The Drug Quality and Security Act.
Their focus was on the compounding of medication for so-called “office use” by doctors and hospitals in their practice settings, sometimes in life-saving scenarios. For example, it is common for hospitals to stock IV fluid bags prepared by compounding pharmacies. In that case and that of compounded drugs on “crash carts” (used to treat cardiac arrest or other life-threatening conditions), it isn’t practical for physicians to write a prescription and only then have the pharmacy compound the drug.
“I want to make clear that this legislation does not change current state law or authority over the dispensing or distribution of medications by pharmacists, compounded or manufactured, for a prescriber’s administration to or treatment of a patient within their practice,” Sen. Coburn said. “The issue of office use, indeed all of pharmacy practice regulation, is best left to the states. So the omission of office use from 503(a) should not signal to the FDA that it has the authority to encroach upon State authority to regulate office use.”
H.R. 3204 “in no way” provides “some new expansive authority to the FDA to restrict interstate commerce or regulate intrastate commerce,” he continued.
“Finally, the legislation does not change the ability of ophthalmologists to administer drugs in their office to individual patients for the purposes of reducing macular degeneration. Under this legislation, physicians retain the ability to use compounding drugs in their office for their patients. This is a practice-of-medicine issue, so the art and science of medicine should not be impeded by the FDA. I will continue to monitor the implementation of section 503(A) in consultation with physicians, medical professionals, and pharmacy professionals. I also strongly encourage the FDA to ensure that these provisions are not used to restrict office use and restrict interstate sales of compounded pharmaceuticals within all applicable laws and regulations.”
“The practice of pharmacy, including pharmacy compounding, is a state issue,” Sen. Boozman said. “Nothing in this law changes that. Compounded drugs for office-use is a state issue. Nothing in this law changes that. Commonplace drug repackaging for drugs—like Avastin®—is a state issue.”
Sen. Boozman continued, “The omission of office-use from section 503(a) of the Food, Drug and Cosmetic Act should not signal to the FDA that it has the authority to encroach upon state authority to regulate office-use. This is not the intent of the law, and I will closely monitor FDA implementation as this process moves forward. If the state of Minnesota wants to prohibit drug repackaging and compounding—that’s its decision. But again, this law is by no means a green light for the FDA to usurp the rights of states. I want to make that crystal clear.”
Both lawmakers are doctors and presumably spoke from first-hand experience with compounded medications in an office setting. Indeed, Sen. Boozman noted that he relied on compounding pharmacies regularly when he practiced in a surgery center.
“Without compounders, doctors would not perform surgeries,” Sen. Boozman concluded. “Without compounders, oncologists would be forced to administer alternative chemotherapy drugs. Without compounders, patients would suffer from limited access. These are real issues and real problems, and we must take these realities into consideration.”
These are among the reasons NCPA endorsed H.R. 3204. NCPA staff will continue to work with policymakers to ensure the legislation is implemented properly.