Applications Now Available for Alaska’s New Licensing Categories and Prescription Standards
Health & Life Sciences Alert 10/14/19 Christine Cassetta, Susan B. Trujillo, Nicholas H. Meza, Richard B. Davis
Effective October 31, 2019, Alaska joined the states that license non-resident wholesale drug distributors, outsourcing facilities, and third-party logistics providers (3PLs). Alaska created these license categories via a new rulemaking, and outlined specific standards for each classification.
While most of the requirements are fairly typical for these categories, a potential non-resident Alaska applicant may want to take note of the following:
- A wholesaler must submit a completed self-inspection of the premises questionnaire on a form provided by the department OR a completed Verification Accredited Wholesale Distributors (VAWD) inspection report.
- A wholesaler seeking to ship into or distribute prescription drugs into Alaska must first verify that the purchaser of the prescription drugs holds a valid license.
- An outsourcing facility must submit the results of the most recent Good Manufacturing Practice (GMP) inspection by the United States Food and Drug Administration as part of its application.
Copies of the new applications are available here.
The new Alaska rulemaking also addresses partial fills and prescription transfers for controlled substance prescriptions.
Specifically, the new regulation provides that a prescription drug order for a Schedule II controlled substance may be partially filled if prescribed for:
(1) a terminally ill patient or a patient residing in a long-term care facility, in accordance with federal law; or
(2) a patient who is not terminally ill or residing in a long term care facility if
(A) the partial fill is requested by the patient or the practitioner that wrote the prescription;
(B) the total quantity dispensed in all partial filling does not exceed the total quantity prescribed;
(C) each partial fill is electronically documented in the patient record;
(D) the remaining portions are filled not later than 30 days after the date on which the prescription is written; and
(E) each partial fill only occurs at the pharmacy where the original prescription order is on file.
The new regulation also clarifies that both original (unfilled) and refill prescriptions may be transferred. This change reflects recent DEA guidance which indicates that original prescription information may be transferred under certain situations.
For more information about how the new Alaska rulemaking may affect your business, please contact your Quarles & Brady attorney or: