Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 32 - BOARD OF PHYSICIANS › Chapter 10.32.23 - Permits for the Dispensing of Prescription Drugs › Section 10.32.23.02 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following terms have the meanings indicated.
B. Terms Defined.
(1) "Board" means the State Board of
				  Physicians.
(2) "Controlled
				  dangerous substance (CDS) " has the meaning stated in Criminal Law Article,
				  §
											5-101(g),
				  Annotated Code of Maryland.
(3)
				  "Dispense " has the meaning stated in Health Occupations Article, §
											12-101, Annotated
				  Code of Maryland.
(4) "Drug sample"
				  has the meaning stated in 21
				  CFR §
												203.3(i).
(5) Final Check.
(a) "Final check" means the verification of
				  the accuracy and completeness of a filled prescription order by the permit
				  holder before the drug is dispensed to the patient.
(b) "Final check" includes the assumption of
				  responsibility for the filled prescription, including verifying the:
(i) Appropriateness of the dose;
(ii) Accurate expiration date;
(iii) Accuracy of the drug
				  dispensed;
(iv) Strength of the
				  drug dispensed;
(v) Labeling that
				  complies with Health Occupations Article, §
													12-505, Annotated
				  Code of Maryland; and
(vi)
				  Appropriateness of the container in which the drug is dispensed, including
				  child-proof containers where applicable.
(6) "In good standing " means that an
				  individual:
(a) Holds a license to practice
				  medicine in this State;
(b) Is not
				  currently suspended by any order imposed by any medical licensing
				  board;
(c) Is not currently on
				  probation by any order imposed by any medical licensing board;
(d) Is not currently subject to any
				  restrictions on practice related to the abuse, misuse, or improper prescribing
				  of drugs;
(e) Has not been within
				  the past 5 years sanctioned by any medical licensing board for the commission
				  of a crime of moral turpitude or for a violation of Health Occupations Article,
				  §
												14-404(a)(7),
				  (8), (9), (10), or (28), Annotated Code of Maryland, or a similar statute of
				  another state; and
(f) Has not
				  within the past 5 years had the CDS registration issued by the OCSA or its
				  predecessor, the registration issued by the federal Drug Enforcement Agency, or
				  the Board dispensing permit:
(i)
				  Revoked;
(ii) Suspended;
				  or
(iii) Voluntarily relinquished
				  or surrendered while under investigation or after being informed that an
				  investigation will be commenced.
(7) "In the public interest" means that a
				  pharmacy is not conveniently available to the patient.
(8) Mechanical Act.
(a) "Mechanical act" means an act which does
				  not require professional judgment, medical or pharmaceutical training, or
				  discretion.
(b) "Mechanical act"
				  does not include:
(i) Selecting a
				  drug;
(ii) Labeling;
(iii) Measuring or calculating
				  dosages;
(iv) Substituting one drug
				  for another, including substituting a generic or brand drug for the prescribed
				  drug;
(v) Substituting one dosage
				  form of a drug for another;
(vi)
				  Altering the route of administration; or
(vii) Counseling
				  patients.
(9)
				  "OCSA" means the Office of Controlled Substances Administration of the Maryland
				  Department of Health.
(10) "Permit
				  holder" means a physician licensed in this State who holds a valid dispensing
				  permit under this chapter.
(11)
				  "Readily retrievable " means maintained by any method by which the permit
				  holder can retrieve and produce the record to OCSA during the course of an
				  unscheduled on-site inspection.
(12) "Sample unit" has the meaning stated in
				  21 CFR §
												203.3(aa).
(13) "Supplier" means:
(a) A wholesale distributor as defined in
				  Health Occupations Article, §
												12-6C-01(v),
				  Annotated Code of Maryland; or
(b)
				  A pharmacy, to the extent permitted by Health Occupations Article, §
												12-406(b),
				  Annotated Code of Maryland.