APhA seeks more clarity on compounder definitions in Senate draft proposal

Association comments on HELP Committee’s draft legislation on drug compounding


In May 3 comments on draft legislation on drug compounding introduced by the Senate Health, Education, Labor, & Pensions (HELP) Committee, 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,” APhA Senior Lobbyist Michael Spira told pharmacist.com.

The April 26 HELP Committee draft legislation would establish a clear boundary between traditional compounding pharmacies and “compounding manufacturers,” and would give FDA greater authority over compounding manufacturers. Compounding manufacturers would be defined as compounding sterile drugs, compounding without patient-specific prescriptions, or selling drugs across state lines. Hospital pharmacies that ship compounded drugs across state lines within the hospital system would not be considered compounding manufacturers.

Under the Senate’s draft proposal, compounding manufacturers would be required to register with FDA, compound drugs under a pharmacist’s oversight, comply with Good Manufacturing Practices, and pay an annual fee of $15,000 if the company had more than 25 employees. They would be prohibited from compounding complex dosages or biologic products made from live organisms, compounding variations of marketed FDA-approved drugs unless the products fulfilled a specific patient need or drug shortages occurred, and compounding products subject to certain Risk Evaluation and Mitigation Strategies unless comparable safety controls were used.

In testimony before both chambers of Congress, FDA has supported more and clearer authority over the compounding industry. The HELP Committee today held a hearing, Pharmaceutical Compounding: Proposed Legislative Solution. Witnesses at the hearing will represent FDA, the National Association of Boards of Pharmacy, the Pew Charitable Trusts, International Academy of Compounding Pharmacists, and American Society of Health-System Pharmacists.

The House Energy & Commerce Committee “may take up legislation later in the year,” Spira said.

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.
  • 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.
  • 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 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, 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.