Drug compounding, which has always been a part of the traditional  practice of pharmacy, involves the mixing, combining, or altering of  ingredients to create a customized medication for an individual patient. Actions Taken or Under Way by States and National Organizations to Strengthen State Oversight of Drug Compounding, but Affect Likely to Vary from State to State

We found efforts at the state level and among national pharmacy  organizations to potentially strengthen state oversight of drug  compounding. Actions among the four states we reviewed included  adopting new drug compounding regulations and random testing of  compounded drugs. At the national level, industry organizations are  working on standards for compounded drugs that could be adopted by  states in their laws and regulations. While these actions may help improve oversight, the ability of states to  oversee and ensure the quality and safety of compounded drugs may be  affected by their available resources and their ability to adopt new  standards and enforce penalties. The pharmacy board in Missouri has taken a different approach  from other states: it is in the process of implementing random batch  testing of compounded drugs. North Carolina. Vermont. Wyoming. Efforts of National Organizations May Help States Strengthen Oversight of Drug Compounding

At the national level, industry organizations are working on uniform  practices and guidelines for compounded drugs and a committee of  national association representatives recently began work on developing a  program that would include certification and accreditation for drug  compounding that could be used for state oversight. For example, of the 307  complaints received and reviewed by the board of pharmacy against  pharmacies and pharmacists in Missouri in fiscal year 2002, only 5 were  related to drug compounding. In practice, however, the agency generally relies  on the states to regulate the traditional practice of pharmacy, including the  limited compounding of drugs for the particular needs of individual  patients. In 1997, the Congress passed a law that exempted drug compounders from  key portions of the FDCA if they met certain criteria. Their efforts,  however, were nullified when the Supreme Court struck down a portion of  the law’s drug compounding section as an unconstitutional restriction on  commercial speech, which resulted in the entire compounding section  being declared invalid. FDA Modernization Act Exempted Drug Compounders from Some FDCA Requirements but Was Declared Invalid

Federal regulatory authority over drug compounding attracted  congressional interest in the 1990s, as some in the Congress believed that  “clarification is necessary to address current concerns and uncertainty  about the Food and Drug Administration’s regulatory authority over  pharmacy compounding.” The Congress addressed this and other issues  when it passed the FDA Modernization Act of 1997 (FDAMA), which  included a section exempting drugs compounded on a customized basis  for an individual patient from key portions of FDCA that were otherwise  applicable to manufacturers. Current FDA Enforcement Focuses on Drug Compounding Outside of the Traditional Practice of Pharmacy

FDA issued a compliance policy guide in May 2002, following the Supreme  Court decision, to offer guidance about when it would consider exercising  its enforcement authority regarding pharmacy compounding. FDA maintains that drug compounding activities are generally  subject to FDA oversight under its authority to oversee the safety and  quality of new drugs, but the agency generally relies on states to provide  the necessary oversight.
Why GAO Did This Study

Drug compounding--the process of mixing, combining, or altering ingredients--is an important part of the practice of pharmacy because there is a need for medications tailored to individual patient needs. Several recent compounding cases that resulted in serious illness and deaths have raised concern about oversight to ensure the safety and quality of compounded drugs. These concerns have raised questions about what states--which regulate the practice of pharmacy--and the Food and Drug Administration (FDA) are doing to oversee drug compounding. GAO was asked to examine (1) the actions taken or proposed by states and national pharmacy organizations that may affect state oversight of drug compounding, and (2) federal authority and enforcement power regarding compounded drugs. This testimony is based on discussions with the National Association of Boards of Pharmacy (NABP) and a GAO review of four states: Missouri, North Carolina, Vermont, and Wyoming. GAO also interviewed and reviewed documents from pharmacist organizations, FDA, and others involved in the practice of pharmacy or drug compounding.

What GAO Found

A number of efforts have been taken or are under way both at the state level and among pharmacy organizations at the national level that may strengthen state oversight of drug compounding. Actions among the four states reviewed included adopting new regulations about compounding and conducting more extensive testing of compounded drugs. For example, the pharmacy board in Missouri is starting a program of random testing of compounded drugs for safety, quality, and potency. At the national level, industry organizations are working on standards for compounded drugs that could be adopted by the states in their laws and regulations, thereby potentially helping to ensure that pharmacies consistently produce safe, high-quality compounded drugs. While these actions may help improve oversight, the ability of states to oversee and ensure the quality and safety of compounded drugs may be affected by state-specific factors such as the resources available for inspections and enforcement. FDA maintains that drug compounding activities are generally subject to FDA oversight, including its authority to oversee the safety and quality of new drugs. In practice, however, the agency generally relies on states to regulate the limited compounding of drugs as part of the traditional practice of pharmacy. In 1997, the Congress passed a law exempting drug compounders that met certain criteria from key provisions of the Federal Food Drug and Cosmetic Act (FDCA), including the requirements for the approval of new drugs. These exemptions, however, were nullified in 2002 when the United States Supreme Court ruled part of the 1997 law to be an unconstitutional restriction on commercial speech, which resulted in the entire compounding section being declared invalid. Following the court decision in 2002, FDA issued guidance to indicate when it would consider taking enforcement actions regarding drug compounding. For example, it said the agency would defer to states regarding "less significant" violations of the Act, but would consider taking action in situations more analogous to drug manufacturing.