Or. Admin. Code § 855-043-0510 - Dispensing Practitioner Drug Outlets - Registration
(1) Unless subject to an exemption in OAR
855-043-0510(2),
a practitioner that engages in dispensing human prescription drug therapies
must register the dispensing site with the board as a DPDO on a form prescribed
by the board, and must renew its registration annually on a renewal form
prescribed by the board.
(2) A
practitioner's facility is exempt from this registration requirement if the
practitioner and facility only engages in:
(A) Dispensing FDA approved drug samples;
or
(B) Dispensing Medication
Assistance Program (MAP) drugs; or
(C) Dispensing homeopathic products;
or
(D) Dispensing natural thyroid
supplemental products; or
(E)
Dispensing a small amount of drugs to start therapy or incidental to a
procedure or office visit, up to a 72 hour supply; or
(F) An amount greater than a 72 hour supply
if the drug is:
(i) A drug in the
manufacturer's original unit-of-use packaging, such as a metered-dose-inhaler
or bottle of fluoride rinse; or
(ii) A full course of therapy, if in the
professional judgment of the practitioner would be in the patient's best
interest, such as a course of antibiotic therapy.
(3) The initial and renewal
applications must state the location of the DPDO and the name of the person
applying for registration. When the person applying for registration is not the
owner of the dispensing site, the application must disclose the name and
address of the owner and the applicant's affiliation with the owner.
(a) If more than one individual owns the
dispensing site, the names and addresses of the partners or persons holding the
three largest ownership interests in the dispensing site must be disclosed on
the application.
(b) If the owner
is a corporation, the application must state the name of the corporation as
filed with the Corporation Division of the Oregon Secretary of State, including
the names of the corporation's officers.
(4) 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.
(5) An initial and renewal applications must
be accompanied by the fee established OAR 855-110.
(6) A certificate of registration will be
issued upon board approval of the application.
(7) The DPDO registration expires March 31,
annually. If the annual renewal fee is not paid by March 31 of the current
year, the applicant for renewal must submit the late renewal fee established in
OAR 855-110 with the renewal application.
(8) The registration is not transferable and
the registration fee cannot be prorated.
(9) The registrant must notify the board 15
days prior to any substantial change to the information provided on the
registration application. Substantial change includes but is not limited to:
change of ownership; change of business name; change of business address;
change of normal business hours; any disciplinary action taken or pending by
any state or federal authority against the registrant, or any of its
principals, owners, directors, or officers.
(10) A new registration form is required for
a change of ownership or location and must be submitted to the board with the
fees as specified in OAR 855-110 15 days prior to the change.
(11) The board may grant a time-limited
waiver exempting DPDO registration when a practitioner licensing board submits
a request to the board with a plan to annually inspect the dispensing facility
to the standards of the board.
(12)
All Supervising Physician Dispensing Outlet registrations expire on March 31,
2022. Outlets that utilize dispensing Physician Assistants must apply for and
be granted registration as a Dispensing Practitioner Drug Outlet upon the
expiration of the Supervising Physician Dispensing Outlet Registration unless
subject to an exemption in OAR
855-043-0510(2).
Notes
Statutory/Other Authority: ORS 689.205
Statutes/Other Implemented: ORS 475.125, ORS 689.155 & ORS 689.305
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