Board of Pharmacy, Chapter 855
Rule Caption: Amend manufacturer rules to clarify registration requirements for out-of-state outlets that perform specific compounding functions
Adm. Order No.: BP 5-2013
Filed with Sec. of State: 8-29-2013
Certified to be Effective: 8-29-13
Notice Publication Date: 6-1-2013
Rules Amended: 855-060-0004
Subject: Manufacturer rules are amended to clarify that any compounded non-patient specific drug from an out-of-state drug outlet may only be distributed into the state by an Oregon registered manufacturer.
Rules Coordinator: Karen MacLean—(971) 673-0001
(1) Any person that manufactures, or contracts for the manufacture of a drug or prescription device that is intended for sale, distribution, dispensing or administration in Oregon must register with the Oregon Board of Pharmacy.
(2) Any person that holds one or more of the following registrations with the Federal Food and Drug Administration (FDA) must register as a Manufacturer.
(a) A New Drug Application number (NDA);
(b) An Abbreviated New Drug Application number (ANDA);
(c) A Labeler Code number (LC) or National Drug Code number (NDC);
(d) An FDA Central File Number (CFN);
(e) An FDA Establishment Identifier number (FEI).
(f) A Biologic License Application (BLA).
(3) A person that is registered with the FDA as a repackager must register as a Manufacturer.
(4) A person whose sole purpose is the marketing, brokering or arranging the initial distribution of drugs manufactured by a manufacturer, but does not take physical possession of a product must register as a Drug Distribution Agent under OAR 855-062-0005.
(5) A person who is registered with the FDA as the Agent for a foreign manufacturer must register as a Drug Distribution Agent under OAR 855-062-0005.
(6) An applicant for a new or renewal of registration must provide all information specified on the form provided by the Board, and pay the fee as specified in OAR 855-110-0007. The applicant must also provide any additional information requested by the Board. An application that does not contain all required information is incomplete and will not be processed.
(7) The registration is non-transferable. Addition or deletion of an owner shall be considered as a change of ownership except where the registrant is a publicly held corporation. A new application for registration and payment of a new registration fee is required when a registrant changes ownership or location. This new application must be submitted to the Board at least 15 days prior to the change.
(8) A person who compounds a drug that is distributed in Oregon not based on a patient specific prescription must register with the Board as a Manufacturer, unless done so pursuant to a Shared Pharmacy Services agreement, as defined in OAR 855-006-0005, between two in-state entities.
Stat. Auth.: ORS 689.205
Stats. Implemented: ORS 689.155 & 689.305
Hist.: BP 9-2011, f. 12-30-11, cert. ef. 1-1-12; BP 1-2013(Temp), f. 3-6-13, cert. ef. 3-7-13 thru 9-3-13; BP 5-2013, f. & cert. ef. 8-29-13
Oregon Secretary of State • 136 State Capitol • Salem, OR 97310-0722
Phone: (503) 986-1523 • Fax: (503) 986-1616 • firstname.lastname@example.org
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