The meningitis outbreak in 2012 - tied to one company in the compounding industry - raised the level of public awareness and created momentum for additional regulation. Most states license businesses in this industry through their Board of Pharmacy. To determine the proper licensure, each state examines the specific actions of the pharmacy within that state. To be compliant, a compounding pharmacy generally must hold a valid pharmacy license in the designated home state of the pharmacy and assign a licensed “pharmacist in charge” to each facility.
The pharmacist in charge must maintain a valid license in the home state and is responsible for the pharmacy’s compliance with all applicable laws and rules. Furthermore, all staff pharmacists must hold valid licenses in the home state, or “domestic” state, of the pharmacy.
If the pharmacy has additional locations or delivers drugs to patients in another state, the pharmacy must maintain a valid license in that state. Some states require that the pharmacist in charge hold an individual license in each additional state.
If the compounding pharmacy sells drugs wholesale, they may need to obtain a wholesale or drug distributor license in every state they transact business.
If the compounding pharmacy conducts activities that fall within the state’s definition of drug manufacturing, they may need to obtain a drug manufacturing license in each state that they engage in compounding activity. Additionally, every state that a pharmacy ships or sells drugs into may require licensing.
Targeted investigatory sweeps occur more and more by state pharmacy boards focused on identifying unlicensed pharmacies and pharmacists operating in their states. Pharmacies of all types must stay educated and aware of licensing requirements that may be pertinent to their operations.
License types include, but are not limited to, pharmacy manufacturer license, pharmacy wholesaler license, pharmacy importer/exporter license, pharmacy re-packer license, and pharmacy retailer license.
States also regulate pharmacy employees as licenses are required for pharmacy technicians, registered pharmacists, and intern pharmacists.