For more than a century, American pharmacies have played a significant role in providing medications to patients. Compounding pharmacies are facilities where pharmacists create custom-made prescription drug mixes made for specific patients. Before mass production, compounding was the main way prescription drugs were made. Within this world of health providers, compounding pharmacies have been a necessary, but less visible, aspect of pharmaceutical policy. Compounding pharmacies continue to manufacture customized prescription drugs for patients for whom mass-produced prescription drugs are not appropriate. Such situations can arise when a patient has an allergy to an ingredient in a mass-produced drug or requires a dosage that is not manufactured on a mass scale.
The Role of the States
The federal Food and Drug Administration (FDA) regulates virtually all commercial pharmaceutical manufacturing. However, states are the primary regulator of pharmacies, including community "drug stores," large chains, in-store pharmacy counters and specialty pharmacies. Every state has laws and regulations guiding pharmacy standards and requirements, addressing issues such as required licenses for each facility and for the credentialed pharmacists and other employees who work there. Virtually every jurisdiction also has requirements for secure storage, recordkeeping, the forms or pads used for patient prescriptions, labeling, and safety protocols related to origins, authenticity, chain of custody, expiration dates of products, purity, sterility and storage, among others. This includes the extra, explicit authority granted to "compound" or mix pharmaceutical ingredients into a patient-ready product. Numerous existing pharmacies have the authority to prepare such products for patients, based on prescriptions written by doctors or other prescribers. Some of these practice requirements have origins dating back 30 to 50 years, when large drug manufacturers played a much smaller role as the source of medication. State rules are updated periodically, commonly under the jurisdiction of individual state Boards of Pharmacy, which operate in the 50 states.
Although states have been the primary regulators of compounding pharmacies in the absence of federal laws addressing these facilities, in the wake of the 2012 meningitis outbreak that was traced to a compounding pharmacy in Massachusetts, federal regulators enacted the Compounding Quality Act. A summary of the act is available here. Click here for the full text of the law.
Compounding Pharmacy Issues
After the potential for harm posed by compounded drugs and compounding pharmacies was highlighted by the 2012 outbreak in Massachusetts, a number of regulatory issues emerged, including:
- Compounding or manufacturing: Is it clear which compounded drug orders meet the state-regulated standard and which cross into a manufacturing regulatory category?
- Definitions: Uniform and up-to-date definitions of compounding, wholesale, specialty and hospital-based pharmacies. Clear language about "sterile" and "non-sterile" compounding.
- Enforcement: Which agencies or boards, state or federal, take action when violations or omissions occur? What levels of penalties are in place? Who can order the closure of an operating pharmacy?
- Funding: Inspection and enforcement agencies have varied levels of budgets and personnel to complete inspections and enforcement.
- Inspection of facilities: How often, by whom, under what conditions. What kind of independent accreditation or evaluation is in place?
- Single-use injectable drugs: Vials sometimes are over-filled and have no preservative added. The makes costs higher, while repeat injection use by some providers brings additional dangers of contamination and infection.
- Transparency: Are records of inspections publicly or adequately available to policymakers and federal and state regulatory entities?
Enacted Laws Affecting Compounding Pharmacies, 2011-Present
Compounding continues to be an issue of interest in the states. So far in 2016, five laws have been enacted in four states. Use the interactive map below to see a summary of laws enacted in each state since 2011. (Click on individual state outlines below). [PDF format]