Pharmacist Group Opposes Legislation to Restrict Compounding

Legislation to strengthen restrictions against pharmacies that manufacture compounding products will deny patients access to necessary medications, the International Academy of Compounding Pharmacists (IACP) said.

Sens. Edward Kennedy (D-Mass.), Richard Burr (R-N.C.) and Pat Roberts (R-Kan.) introduced draft legislation earlier this year that would clarify the FDA’s role in regulating compounding. The legislation never progressed beyond a draft due to opposition from pharmacists, the autism community, women’s health advocates and tens of thousands of patients and prescribers, according to the IACP.

Organizations representing more than 60,000 pharmacists, including the IACP, sent a letter to the bill’s authors, discouraging them from introducing it. The legislation would make it more difficult for patients to receive necessary compounded prescription medications by adding new requirements for prescribing physicians and pharmacists, the letter said.

AngioDynamics President and CEO Eamonn Hobbs recently called for Congress to give the FDA the authority to punish pharmacies that illegally compound medications. A provision allowing the agency to regulate pharmacies that are mass-compounding drugs should be included in S. 1082 and H.R. 2900, bills that would enhance the agency’s safety authorities, Hobbs said. The bills are currently pending before a conference committee.

Last year, the FDA cracked down on companies performing illegal compounding, sending warning letters to manufacturers with orders to stop distributing compounded anesthetic creams and compounding inhalation drugs.