Md. Code Regs. 10.13.01.05

Current through Register Vol. 51, No. 24, December 2, 2024

Section 10.13.01.05 - Inspection Requirements

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.

Md. Code Regs. 10.13.01.05

Regulation .05 adopted effective 42:12 Md. R. 762, eff.6/22/2015; amended effective 45:6 Md. R. 320, eff. 3/26/2018