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Committee reports pharmacy regulation reclassifying outsourcing facilities (Doc. 53-39)
Summary
Document 53-39, reported favorably, reclassifies certain pharmacy outsourcing facilities from 'manufacturer' to 'wholesale distributor' and clarifies permit types tied to pharmacy operation.
Mr. Hogan, a staff member, introduced document 53-39 as a follow-up to legislation passed last year addressing outsourcing facilities. He said the text—a long-standing part of the regulations—affects the classification of certain outsourcing operations.
The proposed change reclassifies a 501(3)(B) outsourcing facility from the designation of manufacturing operation to wholesale distributor. Mr. Hogan explained that the different classifications carry different permits tied to the type of pharmacy operation conducted at a location.
Holly Beeson of the Department of Labor, Licensing and Regulation was available for technical questions; none were raised. The committee moved, seconded and, by voice vote, reported the regulation favorably.
The reclassification will be processed through the committee’s reporting and regulatory publication steps.
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