ARTICLE
21 September 2023

Alaska Board Of Pharmacy Issues Notice Altering The Notification Of Facility Changes

BB
Bass, Berry & Sims

Contributor

Bass, Berry & Sims is a national law firm with nearly 350 attorneys dedicated to delivering exceptional service to numerous publicly traded companies and Fortune 500 businesses in significant litigation and investigations, complex business transactions, and international regulatory matters. For more than 100 years, our people have served as true partners to clients, working seamlessly across substantive practice disciplines, industries and geographies to deliver highly-effective legal advice and innovative, business-focused solutions. For more information, visit www.bassberry.com.
On September 13, the Alaska Board of Pharmacy (Board) issued a notice summarizing a regulatory update stating that pharmacies, wholesale drug distributors, outsourcing facilities...
United States Food, Drugs, Healthcare, Life Sciences

On September 13, the Alaska Board of Pharmacy (Board) issued a notice summarizing a regulatory update stating that pharmacies, wholesale drug distributors, outsourcing facilities, third-party logistics providers, and manufacturers are no longer required to submit an application for name, ownership, or location changes, but must instead notify the Board in writing within 30 days of such a change. In addition, a facility notifying the Board of a change in its physical address must include an attestation that the facility will conduct a new self-inspection within 30 days after business starts. The Board issued this guidance on July 15, 2023, but provided the notice due to continued receipt of applications.

The Board also updated notification requirements for changes to a pharmacy's pharmacist-in-charge, and designated representative (previously referred to as a facility manager) changes for non-pharmacy facilities such as outsourcing facilities, third-party logistics providers, wholesale drug distributors, and manufacturers. A pharmacist-in-charge or designated representative chosen to replace the current pharmacist-in-charge or designated representative in their respective facility must notify the Board in writing within 30 days of their designation. Further, an outgoing designated representative must notify the Board in writing within 30 days of leaving the position. Prior to July 15, such notifications had to be made on an Alaska Department of Professional Regulations-specific form within ten days of a change.

Facilities can make all notifications specified in the Board update through email or a written letter on a company letterhead, sent by one of the following:

  • A pharmacy's pharmacist-in-charge.
  • In the case of outsourcing facilities, third-party logistics providers, wholesale drug distributors, and manufacturers, a facility's designated representative.
  • An owner.
  • Alternative source that can be verified by the Board as originating from the facility.

Pharmacies should remain aware of changes to state-level notification requirements, as failure to abide by such provisions can, depending on individual state law, result in professional discipline, financial penalties, or other negative consequences.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More