Md. Code Regs. 10.32.23.02

Current through Register Vol. 51, No. 22, November 1, 2024

Section 10.32.23.02 - Definitions

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.

Md. Code Regs. 10.32.23.02

Regulation .02 adopted effective 45:6 Md. R. 320, eff. 3/26/2018