Or. Admin. R. 855-060-0001

Current through Register Vol. 63, No. 9, September 1, 2024

Section 855-060-0001 - Application

No place of manufacturing, wholesaling or repackaging of drugs or medicines, as defined in ORS 689.005(20), (35), and (36) may be conducted or operated until it has been registered by the State Board of Pharmacy.

(1) All applications for registration of a new or relocated manufacturer shall be accompanied by the required fees as set forth in OAR 855-110.

(2) Application must specify the location of the manufacturer premises. When the applicant is not the owner of the business, the application shall indicate the owner and the applicant's affiliation with the owner;

(a) If the owner is a partnership or other multiple owner, the names of the partners or person holding the five largest interests shall be indicated on the application.

(b) If the owner is a corporation, the name filed must be the same as filed with the Corporation Commissioner. The name of the corporation, the names of the corporation officers and the names of the stockholders who own the five largest interests must be indicated on the application.

(c) Upon request by the board, the applicant must furnish such information as required by the board regarding the partners, stockholders, or other persons not named in the application.

(3) All registration renewal applications must be accompanied by the annual fee and contain the same information required in subsection (2)(a), (b), and (c) of this rule.

(4) A change of ownership or location requires a new application, fee and registration within 15 days.

(5) The registration certificate is issued to a person or firm and is non-transferable. Additions or deletions of a partner/partners must be considered as a change of ownership.

(6) Manufacturer registration expires September 30th annually. The registration cannot be prorated.

Or. Admin. R. 855-060-0001

1PB 2-1980, f. & ef. 4-3-80; PB 1-1994, f. & cert. ef. 2-2-94; Administrative correction 5-23-00; BP 1-2002, f. & cert. ef. 1-8-02; BP 12-2006, f. & cert. ef. 12-19-06; BP 12-2006, f. & cert. ef. 12-19-06 BP 38-2021, amend filed 12/16/2021, effective 1/1/2022

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155, ORS 689.305, ORS 689.315 & ORS 689.325