Pharmacy Business Licensing

Overview

The Pharmacy industry is regulated by both federal and state law. Every state in the country requires pharmacies to be properly licensed before they can legally operate within its borders. The type of pharmacy license required depends specifically on the activity being conducted. 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. Pharmacy employees are regulated 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 process for your pharmacy, ensuring that you are fully compliant with all registration requirements.

Background

States have a strong interest in regulating pharmacies because of the dangers of distributing drugs that are outdated or expired, are manufactured in substandard facilities, contain dangerous ingredients, have been improperly stored, or are too strong or weak. Most states license businesses in this industry through their Board of Pharmacy.

Initially, a company must obtain an “in-state” or “resident” pharmacy license through their domestic state’s licensing agency. This generally requires an extensive application, varying fees, proof of insurance, a surety bond, copies of policies, procedures, or prescription labels, and an inspection, which is usually scheduled upon approval of the application. This will also require the designation of a registered Pharmacist in Charge (“PIC”). In addition, a Controlled Substance Registration may also be required. Once a company has obtained an in-state license, if it wishes to expand into another state, it must obtain an “out-of-state” or “non-resident” pharmacy license in that state. This process is more of the same, but also may require verification that the business currently holds a resident license (or proof that a license is not required) in the home state.

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 it deals 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.

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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