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#Board of Pharmacy State and Federal Pharmacy Laws - Rules

RECENT RULE CHANGES

On Thursday June 11, 2015 the Board amended or adopted rules in Division 025 Licensure as a Pharmacy Technician, Division 031 School and Preceptor Registration Responsibilities, Division 041 Non Resident Pharmacies, Division 041 Drug Storage 060 Pharmaceutical Manufacturers, 062 Drug Distribution Agents, Division 065 Wholesale Drug Outlets and Division 110 Fees.

Amendments in Division 025 make the Pharmacy Technician license expire the second June 30 from the date of issue, which is not to exceed more than two years.

Amendments in Division 031 make the Preceptor license a biennial license which expires on June 30 in odd numbered years. This corresponds with the Pharmacist biennial expiration date and renewal cycle.

Amendments in Division 041 Non-Resident Pharmacy rules establish requirement for when there is a change in Pharmacist-in-Charge (PIC) in a non-resident pharmacy. It also requires pharmacies to notify the Board of a change in PIC within 10 business days and identify a Pharmacist employed at the location to serve as the Board contact person until a PIC is designated. An Oregon licensed PIC must be employed within 90 days.

New Division 041 Drug Storage rules establish new requirements for the proper storage of drugs, cold storage monitoring and vaccine drug storage. Note that the Drug Storage rules are not effective until January 1, 2016 .

New rules and amendments in Division 060 establish new definitions in the Pharmaceutical Manufacturer rules. Amendments also incorporate outsourcing facilities as one of the Food and Drug Administration (FDA) registration types that must be registered with the Board as a Manufacturer. Third-Party Logistics Providers are directed to register as a Drug Distribution Agent.

Amendments in Division 062 require Third-Party Logistics Providers to register as a Drug Distribution Agent. Amendments also establish new definitions, update minimum requirements for record keeping and inventory management, and update prohibited practices.

Amendments in Division 110 update the Fee rules to reflect that a Pharmacy Technician license issued prior to January 1, 2015 to a person under 18 years of age expires June 30 in odd numbered years. Other updates include listing the three classifications of Manufacturers and the three classification of Wholesalers identified in Division 060 and 065.

On Thursday June 11, 2015 the Board amended by temporary rule, Division 043 Drug Delivery and Control rules. The amendment establishes a waiver clause that will allow requests for exemption of certain requirements if the waived requirements will further public health and safety.

On Thursday June 11, 2015 the Board amended by temporary rule, Division 062 Drug Distribution Agent rules. The amendments update record keeping requirements and identify the information that a Drug Distribution Agent who distributes product to a Wholesaler or Pharmacy must contain in their records. Amendments also reflect that a pedigree must be maintained if a Drug Distribution Agent distributes product to another Drug Distribution Agent.