New Enforcement Tactic by the Alabama BOP for Pharmaceutical Manufacturers: Wholesaler Reporting

Introduction 

In the ever-evolving world of pharmaceutical regulations, the Alabama Board of Pharmacy is employing a known tactic across regulators to identify non-compliance. Drug manufacturers that have their products taken by Alabama patients market have always been subject to a set of licensing requirements; but now, the state will determine which manufacturers need to be licensed by having wholesalers report which manufacturers’ products they distribute within the state.

Reason for Implementation

This measure is designed to further ensure that medications making their way to Alabamian consumers meet stringent safety and quality standards by extending the reach of Alabama’s enforcement capabilities: by identifying, and requiring licensure for, upstream trading partners, the Alabama Board of Pharmacy can better prevent bad-actors from doing business by proxy within the state.

Impact on Distributors

Wholesale distributors, including virtual wholesalers and third-party logistics providers, will now face heightened regulatory oversight. They are mandated to submit the name, address, and Alabama permit number for U.S.-based manufacturers of all regulated drugs or devices that they ship, sell, or cause to be distributed within Alabama.

On the other hand, Private Label Distributors and their Virtual permit holders have a similar, yet distinct, set of requirements. They must provide not only the name and address but also the FDA establishment identification number and the Alabama permit number for their contract manufacturers situated in the U.S. This pertains to all regulated drugs or devices that they channel into the Alabama market.

The Positive Effects

The Alabama Board of Pharmacy’s new regulations emphasize the state’s dedication to safeguarding the quality of pharmaceuticals entering its market. By tasking wholesalers with reporting duties and setting distinct requirements for Private Label Distributors, Alabama is strengthening its commitment to public health. This move may set a trend for other states seeking tighter pharmaceutical oversight.