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Oregon News: Board Adopts New Rules - More on the Way
Published in the February 2010 Oregon State Board of Pharmacy Newsletter
Following the 2009 legislative session, the Board was tapped for a number of new projects, including rule writing and others, as described in the November 2009 Newsletter. The Board has adopted some new rules, and amended some old rules in need of updating, to address new projects and adapt to a variety of new corporate business models for pharmaceutical manufacturing and wholesale drug outlets.
The new rules in the OAR Chapter 855, Division 62, and the amended rules in Division 65, define which entities must register as drug distribution agents and which entities must register as pharmaceutical wholesalers. The new category of drug distribution agent has been created in Division 62 to accommodate individuals and entities that are involved in the drug manufacturing and distribution industry, but do not take ownership or possession of the drug products and are not licensed with the US Food and Drug Administration (FDA) as pharmaceutical manufacturers. The Division 65 amendments are designed to eliminate confusion over the status of repackagers and brokers, to eliminate the requirement for a surety bond for a wholesale drug outlet that is accredited by the NABP Verified-Accredited Wholesale Distributors® accreditation program, and to reclassify certain entities as “Class 2” pharmaceutical wholesalers.
The fee schedule in Chapter 855, Division 110, is amended to include the new category of drug distribution agent and to add the $25 Electronic Prescription Drug Monitoring Fund fee to the pharmacist annual license fee as mandated by Senate Bill 355 (Oregon Laws 2009, Chapter 799).
The text of these new and amended rules are posted on the Board’s Web site at www.pharmacy.state.or.us/ Pharmacy/Laws_Rules.shtml#2009_Rule_Changes.
Besides the rules described above, more new and updated rules are on the way. Notices of proposed rule making and public hearings will be published by the Board pursuant to the state’s administrative procedure manual.
