Senate considers drug compounding bill

APhA comments on Senate draft proposal

The Senate Health, Education, Labor, & Pensions (HELP) Committee on May 15 introduced the Pharmaceutical Compounding Quality and Accountability Act (S. 959) following a full committee hearing and comments from stakeholders, such as APhA, on an April 26 draft proposal.

The Senate compounding bill—a manager’s mark, or updated bill, was released May 20—would draw a line between traditional compounders, which would be regulated primarily by state boards of pharmacy, and “compounding manufacturers,” which would be regulated by FDA; compounding manufacturers would be defined as those that make sterile products without or before a prescription and sell those products across state lines. Pharmacies within health systems would remain regulated as traditional compounders. Compounding manufacturers could not be licensed as pharmacies.

Compounding manufacturers would register with FDA, make products under a pharmacist’s oversight and in compliance with Good Manufacturing Practices, and pay an annual establishment fee to defray the cost of FDA oversight such as inspections and a reinspection fee as needed; small businesses would pay reduced fees.

Traditional compounders would be prohibited from compounding marketed FDA-approved drugs not in shortage, variations of marketed FDA-approved drugs unless they fulfill a specific patient need, or products subject to certain Risk Evaluation and Mitigation Strategies unless it is to fulfill a specific patient need and the compounder uses comparable safety controls. The compounding of certain drugs demonstrably difficult to compound, such as complex dosage forms and biologics, could be prohibited through regulatory rulemaking with comments. Wholesale distribution of compounded products would not be permitted. Marketing of compounded drugs could not be false or misleading.

The Senate compounding bill also would encourage communication among FDA and the states as well as among the states themselves. For more information on the bill, visit the HELP Committee website (

FDA has supported more and clearer authority over the compounding industry in testimony before both chambers of Congress across multiple hearings. As Today went to press, the Senate HELP Committee on May 22 held an executive session where the compounding bill was combined with a new track-and-trace bill (see page 62 for more information on track and trace) into one bill, and the House Energy & Commerce Subcommittee on Health on May 23 held a hearing, Examining Drug Compounding.

The two previous hearings in the House Energy & Commerce Committee were held by the Subcommittee on Oversight and Investigations. “Health holding a hearing means there is a greater likelihood that there will be legislation,” APhA Senior Lobbyist Michael Spira said.

APhA comments on Senate draft proposal

In May 3 comments on the Senate HELP Committee’s April 26 compounding draft proposal, APhA supported the draft proposal’s intention but recommended changes to definitions of traditional compounders and compounding manufacturers, a “do not compound” list, and exceptions to prohibited compounding-related activities.

“We are committed to efforts enhancing patient safety while maintaining patient access to pharmacy compounding services,” APhA wrote in the letter. “We applaud the work of the committee and the intention of the draft proposal for improved patient safety.” 

“APhA’s letter reflected input from our members,” Spira told Today.

Following are highlights of the APhA letter’s suggested changes to the HELP Committee draft proposal:

  • APhA asked for more specificity within the definition of compounding manufacturer or additional exemptions from the new definition for specialty drugs. The Association cited radiopharmaceuticals as an example of a needed exemption and was concerned that language related to repackaging or pooling was too general.
  • APhA believed the definition of traditional compounders should be clear so there is no ambiguity as to who is regulated by state boards of pharmacy and who is regulated by FDA. The Association cited as an example a traditional compounder that compounded a sterile drug with or without a prescription within state lines.
  • Regarding the “do not compound” list, APhA believed providers and scientists on the front lines should provide input in the development and maintenance of the list via an advisory panel that includes pharmacists and physicians and reports science and evidence–based recommendations at least annually to the Secretary of the U.S. Department of Health & Human Services. The Association also recommended rewriting the language within the “do not compound” section to specifically list liposomal compounds that are in the injectable dosage forms.
  • Regarding exceptions to the prohibition of copying marketed drugs, APhA was concerned with the draft proposal’s language on compounding a variation of a marketed drug, including wanting to make sure that it wouldn’t be the pharmacist’s responsibility to validate the physician’s determination of “significant difference” to the patient.

The compounding bill introduced May 15 addressed some of the concerns in the Association’s letter to the Senate HELP Committee. The third version of the proposal, referred to as the manager’s mark or as the “amendment in the nature of a substitute,” that was released on May 20 addressed additional concerns in the Association’s letter. That updated bill followed a May 16 conference call from the HELP Committee to APhA staff to gather further stakeholder input. 

The compounding bill specified that “a pharmacy that compounds positron emission tomography drugs or radiopharmaceuticals shall be considered a traditional compounder if it does not compound other drugs that would cause it to be a compounding manufacturer.” It also clarified pooling, repackaging, and other terms.

The bill did not include the phrase “significant difference.” Instead, the bill specified that a variation of a marketed drug could be compounded only if “the compounded variation produces for the patient a clinical difference between the compounded drug and such marketed drug, as determined by the prescribing practitioner.”

The updated bill went further by explicitly requiring the government to consult with “pharmacists” twice: before establishing the “do not compound” list, and before implementing the entire legislation.

Senate hearing on draft proposal

On May 9, FDA and pharmacists testifying at the Senate HELP Committee hearing generally supported the committee’s draft proposal. There was some disagreement on details.

The full committee held the hearing Pharmaceutical Compounding: Proposed Legislative Solution to refine the draft proposal with input from stakeholders including FDA and pharmacists representing the National Association of Boards of Pharmacy (NABP), the Pew Charitable Trusts, International Academy of Compounding Pharmacists (IACP), and American Society of Health-System Pharmacists (ASHP).

“From the general tone, I think we’re very, very close,” said Sen. Tom Harkin (D-IA), Chair of the HELP Committee, at the end of the 2-hour hearing. 

The witness on the first panel was Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA. “We’re here because of an appalling tragedy,” Woodcock said, referring to the fungal meningitis outbreak linked to the New England Compounding Center that had resulted in at least 55 deaths and 741 illnesses in 20 states, according to the latest counts from CDC. “This bill is a huge step in the right direction.”

Woodcock sought clear authority to look at records particularly in the case of an outbreak and a delayed effective date of compounding legislation.

Asked by Sen. Al Franken (D-MN) whether mom-and-pop pharmacies would have to change their current practices, Woodcock replied, “No, the traditional pharmacy compounding will not substantively change. Period.”

The second panel’s witnesses were Carmen Catizone, MS, BSPharm, Executive Director, NABP; Allan Coukell, BScPharm, Director, Medical Programs, Pew Charitable Trusts; David G. Miller, BSPharm, Executive Vice President and CEO, IACP; and Kasey K. Thompson, PharmD, Vice President, Office of Policy, Planning, and Communications, ASHP.

Catizone indicated that most provisions in the draft proposal “align well with the approach suggested by the states.” NABP supported FDA authority to “seize any and all records required for oversight of compounding manufacturers” but was “concerned that requirement could create a confusing situation” and called for “better communication”; and NABP believed that non–patient-specific intrastate activities fall within the scope and authority of FDA because “the same risks happen with intrastate compounding as with interstate compounding.”

Coukell said he was pleased to support the draft legislation but urged the committee to allow FDA to access records and said some important areas of risk were not addressed by the proposal, including products produced within states.

Miller said, “I think we’re close. We’re not there yet, but we’re close.” His statement focused on what he called consistency, accountability, and patient protection. In the patient protection category, Miller was opposed to the exemption for hospital pharmacies.

Thompson called the draft proposal “thoughtful and well developed.” He supported the provision exempting health systems from being designated as compounding manufacturers, noting that “hospitals and health systems are not engaged in the retail sale of compounded products but instead for the patients being cared for in their hospitals, health systems, and clinics.”

Harkin asked the four pharmacists whether the draft proposal drew a clear line for FDA and states. They each said “yes,” but Miller added, “With [better] definitions.” Harkin asked the pharmacists whether the draft proposal provided tools for FDA. They each agreed, but Coukell said, “Some tools, not all”; and Thompson said that he supported the user fees but was concerned about general funds for FDA.

Then Harkin zeroed in on areas of disagreement among the pharmacy groups. Noting that Miller had testified that hospitals should not be exempt and Thompson had testified in support of the exemption, Harkin asked Catizone and Coukell to weigh in on whether hospital systems should be exempt. Catizone and Coukell supported the exemption.

Sen. Lamar Alexander (R-TN) pursued the question of FDA access to records. Coukell indicated that FDA should have access, while the other three were not as supportive of FDA access to records.

Toward the end of the hearing, Sen. Pat Roberts (R-KS), a veteran of previous attempts by Congress to regulate the compounding industry, told Miller, “I’m glad you’re on the stagecoach.”