Compounders Pharmacy Licensing

Overview

Both federal and state law regulates the Compounding Pharmacy industry. Every state in the country requires proper licensure of compounding pharmacies before they can legally operate within its borders. The type of pharmacy license required depends specifically on the activity of the pharmacy. 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.

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States regulate pharmacy employees as well, requiring licenses to act as a pharmacy technician, a registered pharmacist, and an intern pharmacist. As licensing specialists, we are familiar with the licensing laws and requirements of each state. Let LicenseLogix streamline the application and renewal process for your pharmacy, ensuring that you are fully compliant with all registration requirements.

Background

States have a strong interest in regulating pharmacy compounders because of the serious health dangers of distributing drugs. 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 manufacture 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.

LicenseLogix assists every type of business entity in researching, obtaining, and maintaining their licenses or permits. The licensing specialists are experts on business and professional licenses in a wide range of industries such as pharmacy licenses, mail order pharmacy licenses in all 50 states.

Ramifications of Non-Compliance

A pharmacy operating without a license, or with an expired license, may be subject to fines as well as criminal prosecution if dealing with controlled substances. In 2009, the Texas State Board of Pharmacy began cracking down on licensed pharmacies whose pharmacists or technicians did not hold a Texas license or held an expired license. In 2013, the Tennessee Pharmacy Board enacted new rules for compounding pharmacies.

How we help your business:

  1. We stay up-to-date with changing requirements and forms so you can focus on the job at hand.
  2. We complete license applications efficiently and correctly, allowing your in-house staff to save valuable time struggling to obtain the proper licenses.
  3. Once your license has been issued, we ensure that you remain compliant with all licensing laws.

More Resources:

- National Association of Boards of Pharmacy
- National Community Pharmacists Association
- American Society of Health-System Pharmacists


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