Or. Admin. Code § 855-062-0020

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

Section 855-062-0020 - Registration

(1) Any person engaged in any part of the process of manufacture or wholesale distribution of a drug into, out of, or within Oregon must be registered with the board. A person must register as either:

(a) A manufacturer under Division 60 of this chapter of rules; or

(b) A wholesaler under Division 65 of this chapter of rules; or

(c) A Drug Distribution Agent under this division of rules.

(2) A person that is required to register as a Drug Distribution Agent must be registered before commencing business in Oregon and before any drug for which they provide a manufacturing, marketing or distribution service, may be sold, distributed, dispensed or administered in Oregon.

(3) A person that is required to register as a Drug Distribution Agent must apply for registration on a form provided by the board and must provide information required by the board that includes but is not limited to:

(a) The name, business address, social security number or 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) Every trade or business name used by the applicant;

(c) Any disciplinary action taken by any state or federal authority against the applicant or any other 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.

(4) An applicant for renewal must complete the form provided by the board and submit it to the board with the appropriate fee by September 30 annually.

(5) An applicant that provides a manufacturing or distribution service in respect of a controlled substance as defined in Division 80 of this chapter of rules must also complete and submit the Controlled Substance registration form provided by the board, with the appropriate fee.

(6) The board may require a criminal history and financial background check of each principal, owner or officer of the applicant prior to initial registration and prior to any renewal unless the applicant is publicly traded. Any such checks will be at the applicant's expense.

(7) The board may require a physical inspection of each facility prior to initial registration and prior to any renewal.

(8) Each separate business entity and each location that does business in Oregon must be separately registered by the board.

(9) The registrant must notify the board, within 15 days, of any substantial change to the information provided on the registration application. Substantial change includes but is not limited to:

(a) Change of ownership;

(b) Change of business address;

(c) Any disciplinary action taken or pending by any state or federal authority against the registrant, or any of its principals, owners, directors, officers.

(10) The registration certificate is issued to a specific person and is non-transferable. Any addition or deletion of an owner or partner constitutes a change of ownership.

(11) The board may waive any requirement of this rule if, in the board's judgment, a waiver will further public health or safety. A waiver granted under this section will only be effective when issued in writing.

Or. Admin. Code § 855-062-0020

BP 2-2009(Temp), f. 6-22-09, cert. ef. 6-26-09 thru 12-23-09; BP 5-2009, f. & cert. ef. 12-24-09; BP 52-2022, amend filed 12/20/2022, effective 12/21/2022

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155