Current through Register Vol. 51, No. 19, September 20, 2024
A. The
Board of Dental Examiners, the Board of Physicians, and the Board of Podiatric
Medical Examiners shall report annually to the Office of Controlled Substances
Administration the names and addresses of its licensees who:
(1) Are authorized to personally prepare and
dispense prescription drugs; and
(2) Have reported to the appropriate Board
that they have personally prepared and dispensed prescription drugs within the
previous year.
B. A
licensee shall allow the Office of Controlled Substances Administration to
enter and inspect the licensee's practice locations at all reasonable
hours.
C. The Office of Controlled
Substances Administration shall:
(1) Enter
and inspect the practice locations of a licensee who holds an initial
dispensing permit:
(a) Within 6 months after
receiving the annual report set forth in §A(1) of this regulation;
and
(b) At least one more time
during the duration of the permit;
(2) If a licensee who holds an initial
dispensing permit has more than one practice location:
(a) Enter and inspect a practice location of
the licensee within 6 months after receiving the annual report set forth in
§A(1) of this regulation; and
(b) Enter and inspect a different practice
location at least one time during the duration of the permit;
(3) If a licensee who holds a
dispensing permit is seeking renewal:
(a)
Enter and inspect a practice location of a licensee at least two times during
the duration of the permit; and
(b)
If licensee has more than one practice location, enter and inspect two
different practice locations during the duration of the permit;
(4) If the Office of Controlled
Substances Administration finds a deficiency at one practice location of a
licensee with multiple practice locations, require the licensee to prepare,
sign, and submit an affidavit attesting that all practice locations are in or
will be in compliance as a result of the inspection;
(5) Report to the Board of Pharmacy a
wholesale distributor not licensed in Maryland; and
(6) Report the results of the inspections
required under §C(1) and (2) of this regulation to the respective board of
licensure.
D. A licensee
shall sign and date an inspection form provided by the Office of Controlled
Substances Administration relating to the requirements set forth in Health
Occupations Article, §12-102, Annotated
Code of Maryland.
E. A licensee
shall pay a fee in an amount that will produce funds to approximate, but not
exceed, the documented costs to the Office of Controlled Substances
Administration for inspections, as required by the appropriate Board.
F. The Office of Controlled Substances
Administration:
(1) May suspend inspections
of any physician who reports pursuant to Health Occupations Article, §12-102(c)(2)(ii)
4L, Annotated Code of Maryland, that the physician has not personally dispensed
any prescription medications during the preceding year; and
(2) To the extent otherwise required by this
regulation, shall resume inspections if that physician later reports that the
physician has resumed dispensing activities.
