OAR 855-065-0006
Registration Requirements
(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 (Fees for Registration, Renewal, and Reinspection of Drug Outlets) and 855-110-0010 (Fees for Registration for Controlled Substances under ORS 475.095). 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:(a)
The name, business address, social security number and federal tax identification number of each owner, officer, and stockholder owning more than 10 per cent of the stock of the company, unless the stock of the company is publicly traded;(b)
All trade or business names used by the applicant including any businesses outside Oregon;(c)
The names, addresses and telephone numbers of the designated representatives for all facilities used by the applicant that engage in wholesale distribution into, out of, or within Oregon;(d)
The normal business hours for the applicant; and(e)
Any disciplinary action taken by any state or federal authority against the applicant or any other wholesale distributor under common ownership or control, or any owner, principal or designated representative of the applicant, in connection with the drug laws or regulations of any state or the federal government.(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:(a)
A current license or registration as a wholesale distributor in a state that has a license or registration procedure approved by the Board that included a physical inspection within the past three years; or(b)
A current accreditation by a process approved by the Board such as The National Association of Boards of Pharmacy’s Verified Accredited Wholesale Distributor (VAWD) program or other nationally recognized accreditation program or contract inspection service.(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:(a)
A current accreditation by a process approved by the Board such as The National Association of Boards of Pharmacy’s Verified Accredited Wholesale Distributor (VAWD) program or other nationally recognized accreditation program or contract inspection service; or(b)
That it is a small business as defined in ORS 183.310 (Definitions for chapter)(10); and(A)
The applicant has no affiliation with any out-of-state pharmaceutical company; and(B)
All owners and principals of the applicant are Oregon residents; and(C)
No owner or principal, or close family member of an owner or principal, has a controlling or business interest in any other pharmaceutical company; and(D)
Neither the applicant, nor any of its owners or principals, has ever been found to be in violation of any drug law or regulation in this or any other state.(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:(a)
Are related to a registration held by the wholesale distributor; and(b)
Are authorized under Oregon law; and(c)
The wholesale distributor fails to pay less than thirty days after the penalties, fees, or costs become final.(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:(a)
An administrative or legal proceeding before or on behalf of the Board that involves the wholesale distributor and results in penalties, fees or costs; or(b)
An appeal of such a proceeding.(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 (Fees for Registration, Renewal, and Reinspection of Drug Outlets) 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.
Source:
Rule 855-065-0006 — Registration Requirements, https://secure.sos.state.or.us/oard/view.action?ruleNumber=855-065-0006.