New Alabama Law Imposes Designated Representative Registration Requirements for Wholesalers and Manufacturers

Quarles & Brady LLP

Quarles & Brady LLP

Beginning on January 1, 2024, pursuant to recently passed Alabama House Bill 79 individuals serving as the designated representative for an Alabama-licensed facility will be required to hold an Alabama designated representative registration. This new 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 new law requires each permit holder (except for outsourcing facilities and pharmacies) to "designate a current representative of the permit holder and … register the designated representative with the board. The designated representative shall possess the qualifications, requirements, and background as set out by the board." Presumably, the Alabama Board of Pharmacy will initiate a rulemaking process to lay out the registration requirement, though we suspect the qualifications will be like what currently exists for designated representatives at Ala. Admin. Code 680-X-2-.23(1).

While the Alabama Board of Pharmacy has not yet released their public May 17th meeting minutes (which occurred after the passage of the law), the Alabama Board of Pharmacy noted the bill during their April meeting. The minutes stated that that this new law is intended to bring Alabama into compliance with the Drug Supply Chain Security Act (DSCSA) by naming a designated representative to be registered with the Board. While it's unclear what requirements the Alabama Board of Pharmacy will ultimately implement, it is worth noting that nothing in the DSCSA or the corresponding proposed national standards for wholesalers require a designated representative to be "registered" with any state or federal authority.

Though the Alabama Board of Pharmacy may ultimately take steps to mitigate the impact of this registration, this registration requirement may create operational difficulties for permittees under existing Alabama law and rule. Alabama currently requires a permit holder to notify the Board of Pharmacy within ten days of a change in designated representative by completing the “Notice of Change of Designated Representative” form. This form requires the permittee to identify a new designated representative upon notice of the change. This newly added registration process may create difficulties for a permittee in the event a designated representative ceases employment unexpectedly, and the registration processing takes a significant amount of time. This would be similar to the current problems created by the California designated representative licensing requirement, since the licensing process takes far longer than the 30-day window a facility has to identify a new designated representative.

In comparison, on the pharmacy side, Alabama law requires a 10-day notice in the event a pharmacist-in-charge changes but allows a longer window to name a new pharmacist-in-charge. We’re hopeful the Alabama Board of Pharmacy will opt to mirror this process for wholesalers and manufacturers to allow these businesses a reasonable timeframe to identify and register a new designated representative.

We will continue to monitor any Alabama rulemaking in this space. All affected businesses should also monitor this rulemaking and be prepared to make their voices heard during the notice and comment process.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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