Oregon Administrative Rules
Chapter 855 - BOARD OF PHARMACY
Division 65 - WHOLESALE DRUG OUTLETS
Section 855-065-0006 - Registration Requirements
Current through Register Vol. 63, No. 3, March 1, 2024
(1) Every wholesale distributor, wherever located, that engages in wholesale distribution into, out of, or within Oregon must be registered with the Board in accordance with the laws and regulations of Oregon before engaging in wholesale distribution of drugs. Every applicant for registration or renewal of registration must pay the appropriate fee in accordance with OAR 855-110-0007 and 855-110-0010. An applicant must register as a Class I Wholesaler or a Class II Wholesaler unless the applicant qualifies for registration as a Drug Distribution Agent under Division 62 of this chapter of rules.
(2) Application for registration must be on a form approved by the Board and must include, but not be limited to, the following information:
(3) The Board may require a criminal history and financial background check of each principal, owner, officer and designated representative of the applicant prior to initial registration and prior to any renewal. Any such checks shall be at the applicant's expense.
(4) The Board may require a physical inspection of each facility prior to initial registration and prior to any renewal.
(5) Any wholesale distributor located outside the boundaries of Oregon, applying for registration or re-registration, as a Class I Wholesaler, must provide evidence of one of the following:
(6) Any wholesale distributor located inside the boundaries of Oregon, applying for registration or re-registration, as a Class I Wholesaler, must provide evidence of one of the following:
(7) In addition to the above registration requirements, an applicant for registration as a Class I wholesaler under this rule, that has not received VAWD accreditation, must provide evidence that it has obtained a bond or equivalent means of security of at least $100,000 that provides direct access to the Oregon Board of Pharmacy as a beneficiary to secure payment of any administrative penalties that may be imposed by the Board and any fees and costs that may be incurred by the Board and that:
(8) The Board may make a claim against a bond or security posted under section (7) of this rule within one year after the wholesale distributor's registration is no longer valid or sixty days after the conclusion of whichever occurs later:
(9) Where operations are conducted at more than one location by a single wholesale drug outlet, each such location that does business in Oregon must be registered by the Board.
(10) The registrant must notify the Board, within 15 days, of any substantial change to the information provided on the registration application. Substantial change shall include but not be limited to: change of ownership; change of business address; change of normal business hours; any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers, or designated representatives.
(11) The registration certificate is issued to a specific person and is non-transferable. Additions or deletions of an owner or partner shall be considered as a change of ownership.
(12) A new registration form is required for a change of ownership or location and must be submitted to the Board with the fees as specified in OAR 855-110-0007 within 15 days of the change.
(13) Upon written request, the Board may waive any of the requirements of this rule if a waiver will further public health or safety. A waiver granted under this section shall only be effective when it is issued in writing.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155