Are You Ready for Alabama’s New Designated Representative Requirements?

In a previous update, Quarles discussed a new Alabama law that requires individuals serving as the designated representative for an Alabama-licensed facility to register with the Alabama Board of Pharmacy ("the Board”) as of January 1, 2024. This requirement applies to every manufacturer, bottler, packager, repackager, third-party logistic provider, wholesale drug distributor, and private label distributor permitted in Alabama. Outsourcing facilities are expressly exempt from the new designated representative registration requirement.

The form to register designated representatives will be available on the Board’s website soon.

To address these new requirements, the Board updated Ala. Admin. Code 680-X-2-.23, and the updates take effect on January 14, 2024. The rule addresses the Board’s required qualifications for designated representatives. The designated representative must:

• Be at least 21 years of age;
• Be a citizen of the United States or be legally present in the United States;
• Be employed by the facility full-time in a position of authority and be physically present at the facility for a minimum of 50% of the hours the facility is in operation or at least thirty (30) hours per week, whichever is less;
• Be actively involved in and aware of the actual daily operation of the facility;
• Serve as a designated representative for only one physical location for a permitted facility at any one time;
• Not have been convicted of a violation of any federal, state, or local law relating to any drug offense; and
• Not have been convicted, received adjudication, community supervision, or deferred prosecution of any felony offense or any crime related to fraud, violence, sexual violations or related to the practice of pharmacy.

Per the rule, permittees are required to notify the Board of a change in the designated representative within 10 days by submitting a “Notice of Change of Designated Representative” form. However, if the permittee is unable to maintain a designated representative, the permittee can notify the Board within 10 days with an action plan to appoint another designated representative within 90 days.

Allowing up to 90 days to replace the designated representative should reduce the operational difficulties some permit holders experience. Once the rule takes effect, should a designated representative leave the position suddenly, the permittee has more time to locate a replacement and register the new designated representative.

If you have questions regarding this new Alabama law, please contact your Quarles attorney or:

• Susan Trujillo: (602) 229-5318 / susan.trujillo@quarles.com
• Nicholas Meza: (602) 229-5439 / nicholas.meza@quarles.com
• Andrea Seach: (602) 229-5200 / andrea.seach@quarles.com