OAR 855-060-0001
Application

No place of manufacturing, wholesaling or repackaging of drugs or medicines, as defined in ORS 689.005 (Definitions)(20), (35), and (36) shall be conducted or operated until it has been registered by the State Board of Pharmacy, except that compounding or repackaging, as a part of a Shared Pharmacy Services agreement as defined in OAR 855-006-0005 (Definitions)(20), does not constitute manufacturing. Manufacturing registration expires September 30th annually:

(1)

All applications for registration of a new or relocated manufacturer shall be accompanied by the required fees as set forth in 855-110-0007 (Fees for Registration, Renewal, and Reinspection of Drug Outlets)(3).

(2)

Application shall 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 shall 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 shall be indicated on the application.

(c)

Upon request by the Board, the applicant shall 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 shall 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 shall be considered as a change of ownership.

(6)

The registration cannot be prorated.

Source: Rule 855-060-0001 — Application, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=855-060-0001.

Last Updated

Jun. 8, 2021

Rule 855-060-0001’s source at or​.us