(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.
Any person that holds one or more of the
following registrations with the Food and Drug Administration (FDA) must
register as a Manufacturer.
(a) A New Drug
Application number (NDA);
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);
FDA Establishment Identifier number (FEI);
(f) A Biologic License Application (BLA);
(g) An Outsourcing Facility
person that is registered with the FDA as a repackager must register as a
(4) A person who is
a third-party logistics provider as defined in Division 62 or whose sole
purpose is the marketing, brokering or arranging the initial distribution of
drugs manufactured by a manufacturer must register as a Drug Distribution Agent
under Division 62.
(5) A person
who is registered with the FDA as the agent for a foreign manufacturer must
register as a Drug Distribution Agent under Division 62.
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
(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.
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
Or. Admin. R.
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;
4-2015, f. & cert. ef.
Stat. Auth.: ORS
Stats. Implemented: ORS