Or. Admin. Code § 855-065-0009

Current through Register Vol. 63, No. 12, December 1, 2024

Section 855-065-0009 - Personnel

As a part of the registration or re-registration application, an applicant for registration as a Class I Wholesaler must name a Designated Representative (DR) for each wholesale distributor registered under these rules. The DR must:

(1) Be employed in a full-time managerial position by the wholesale distributor and may not be listed as the DR for more than one registrant without the specific written authority of the Board.

(2) Have at least two years verifiable full-time managerial or supervisory experience in a pharmacy or with a wholesale distributor registered under these rules or with another state.

(3) Have verifiable experience in record keeping and storage of prescription drugs.

(4) Be actively involved in and aware of the daily operations of the wholesale distributor.

(5) Be knowledgeable about all policies and procedures of the wholesale distributor.

(6) Be physically present at the wholesale distributor during normal business hours, which must be posted to be visible to the public, except when absent due to emergency, authorized absence or legitimate business reason (as used in this rule, "normal business hours" means at least six hours between 6.00 am and 7.00 pm on at least five days between Monday and Saturday every week, excluding national and local holidays). Class I wholesalers located within Oregon must designate a replacement DR and notify the Board accordingly, when any absence of the DR exceeds 15 days.

(7) The DR must conduct a self-inspection of the facility by September 1 each year, and document the results of this self-inspection on Oregon Wholesaler Self-Inspection Form provided by the Board. The DR must certify in writing, under penalties of perjury, that the information recorded on the Oregon Wholesaler Self-Inspection Form is correct. This form must be retained for three years and must be made available to the Board within two days upon request.

(8) The DR must ensure that the wholesale drug outlet has policies and procedures in effect and implemented to ensure that the outlet employs adequate personnel with the education and experience necessary to engage in the wholesale distribution of drugs safely and lawfully.

Or. Admin. Code § 855-065-0009

PB 3-1992, f. & cert. ef. 3-26-92 (and corrected 4-8-92); BP 12-2006, f. & cert. ef. 12-19-06

Stat. Auth.: ORS 689.205

Stats. Implemented: ORS 689.155 & 689.315, 689.325