Subject of Possible Rule Making: Pharmaceutical manufacturers and wholesalers licensing requirements. The pharmacy quality assurance commission (commission) is considering amending WAC 246-945-246 and 246-945-247, and potentially adding new sections in chapter 246-945 WAC, if necessary, to update and clarify the requirements for wholesalers and manufacturers including virtual entities and over-the-counter only wholesalers.

Reasons Why Rules on this Subject may be Needed and What They Might Accomplish: The commission has jurisdiction over licensing pharmaceutical manufacturers and wholesalers. The commission has received an increasing number of manufacturer and wholesaler applications from entities that are virtual. These virtual entities contract with other manufacturers that produce the drugs and third-party logistics companies which transport the drugs, meaning the virtual entities never come in contact with the drugs. As written, the commission's rules do not clearly address virtual entities that work with pharmaceutical manufacturing and wholesaling.

The commission also receives applications for facilities that produce over-the-counter only drugs. Facilities that are located out-of-state have difficulties producing inspections because some states don't require inspections for over-the-counter only manufacturers.

Through this rule making, the commission will consider updating and clarifying its rules to address these issues for wholesalers and manufacturers seeking licensure in Washington.

Interested parties can participate in the decision to adopt the new rule and formulation of the proposed rule before publication by contacting Haleigh Mauldin, P.O. Box 47852, Olympia, WA 98504-7852, phone 360-890-0720, TTY 711, email PharmacyRules@doh.wa.gov, website doh.wa.gov.

Additional comments: Interested parties can participate in the drafting of the proposed rules. The commission will conduct a series of rules workshops. Rule-making notices will be delivered via the GovDelivery list. To receive notices, please go to https://public.govdelivery.com/accounts/WADOH/subscriber/new. After signing in, please click open the box labeled "Health Systems Quality Assurance." Next, click open the box labeled "Health Professions" and then click again on "Pharmacy Commission Newsletter." You may also check the box next to one or more of the other professions or facilities listed to receive information related to that specific topic.