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Alabama News: Controlled Substance Registration Waiver
Published in the August 2007 Alabama State Board of Pharmacy Newsletter
The Alabama Uniform Controlled Substances Act mandates that every person or entity who manufacturers, distributes, or dispenses any controlled substance (CS) within Alabama or who proposes to do so must obtain annually a registration from the Alabama State Board of Pharmacy. This mandate also includes wholesalers.
Based upon an opinion from the Alabama attorney general issued on June 4, 1982, the Board required a registration even if the person or entity did not manufacture, distribute, or dispense CS or propose to do so. In part due to the evolution of, and changes in, the profession (for example, the advent of limited purpose or service pharmacies) the Board requested the attorney general to review the earlier opinion and determine if a registration was required when an individual or entity did not engage in the referenced activities pertaining to CS. On August 16, 2006, the attorney general issued an opinion which in part states:
The controlled substances registration is not required as a condition of practicing pharmacy, operating a pharmacy or manufacturing where no person or firm is actually engaged in the manufacture, distribution, or dispensing of any controlled substance, or proposes to engage in the manufacture, distribution, or dispensing of any controlled substance.
As a result, individuals or entities are now allowed to “opt out” of obtaining a registration by completing a waiver to be filed with the initial application for, or renewal of, any applicable license or permit. In seeking this waiver, the applicant is representing that no activities or proposed activities requiring the registration will be performed during the period covered by the license or permit.
A note of caution: if a waiver is obtained and later any change occurs that would require registration, and you fail to obtain the registration before the referenced activities take place, you are subject to discipline. In other words, rather than being valid for the period covered by the license or permit, the wavier is only valid if you do not engage in the referenced activities. A Controlled Substance Registration Waiver is available on the Board Web site at www.albop.com.
