AARC Supports Petition on Pharmacy Compounding of Inhalation Drugs
April 1, 2005
The AARC has signed on to a new Citizen’s Petition on its way to the Food and Drug Administration (FDA). The goal: informing patients and practitioners alike about potential quality problems related to pharmacy compounded aqueous-based drugs for inhalation.The petition is being issued by the Consumer Health Alliance for Safe Medication (CHASM), a coalition of patient and health professional organizations. The AARC is an integral part of the group.
CHASM specifically wants the FDA to ensure pharmacies label these medications so that patients and practitioners both know they are not FDA approved and that they were compounded in a pharmacy and thus were not manufactured under FDA standards for good manufacturing practice, do not comply with FDA sterility standards, and have not been demonstrated to be safe or effective.
The Citizen’s Petition also calls on the FDA to:
- Ensure that pharmacies are aware of their obligation to disclose information regarding compounded medications in their labeling and advertisements and propose a regulation to provide specific wording for this purpose.
- Inform the public of a pharmacy’s statutory requirement to provide this information and advise patients to consult with their prescribing health care professional regarding any concerns they have with compounded medications.
- Require pharmacies, in some instances, to notify each health care professional who submitted a prescription and/or notify each patient that the required information regarding the compounded medication was not provided to them.
The move grew out of the growth in pharmacies substituting prescribed FDA approved medications with pharmacy compounded medications and not disclosing appropriate information regarding these medications to patients and their health care providers.
