10.13.01.04

.04 Dispensing Requirements.

A. A licensee shall submit an application to the appropriate Board on the form that the Board requires.

B. A licensee may not dispense prescription drugs until a written permit is received from the appropriate Board, except that a written permit is not required in order to dispense starter dosages or samples provided without charge.

C. A licensee shall personally prepare and dispense prescription drugs.

D. Except as provided in Health Occupations Article, §12-102(c)(2)(iii), Annotated Code of Maryland, and §S of this regulation, a licensee shall dispense prescription drugs only to the patients of the licensee.

E. A licensee shall comply with the labeling requirements set forth in Health Occupations Article, §12-505, Annotated Code of Maryland.

F. A licensee shall comply with the child resistant packaging requirements set forth in Health-General Article, Title 22, Subtitle 3, Annotated Code of Maryland.

G. A licensee shall comply with drug recalls.

H. A licensee shall record the dispensing of the prescription drug on the patient's chart.

I. A licensee may not have a substantial financial interest in a pharmacy.

J. A licensee shall, except for starter dosages or samples provided without charge, provide the patient with a written prescription.

K. A licensee shall maintain for at least 5 years:

(1) A separate file for Schedule II prescriptions; and

(2) Another file for other prescriptions.

L. A licensee shall maintain biennial inventories of all stocks of controlled substances.

M. A licensee shall dispense prescription drugs to a patient only when the patient determines that a pharmacy is not conveniently available to the patient.

N. In each patientís chart for each patient to whom prescription drugs are dispensed or in a format readily retrievable, a licensee shall maintain a single form which:

(1) Indicates that a pharmacy is not conveniently available to the patient;

(2) States that the determination that a pharmacy is not conveniently available was made solely by the patient; and

(3) Is signed and dated by the patient before dispensing prescription drugs to the patient for the first time.

O. A licensee shall display prominently a sign which informs the patient that prescription drugs can be purchased from the permit holder if the patient determines that a pharmacy is not conveniently available to the patient.

P. A licensee may not make any agreement that denies a patient a free choice of pharmacist or pharmacy services.

Q. A licensee shall post a sign conspicuously positioned and readable regarding the process for resolving incorrectly filled prescriptions or includes written information regarding the process with each prescription dispensed.

R. A licensee shall maintain at all times the minimum professional and technical equipment and sanitary appliances that are necessary to prepare and dispense prescriptions properly.

S. To the extent permitted by COMAR 10.32.23, a licensed physician may personally prepare and dispense a prescription written by:

(1) A physician assistant with whom the physician has a delegation agreement that:

(a) Complies with Health Occupations Article, Title 15, Subtitle 3, Annotated Code of Maryland; and

(b) Permits the physician assistant to prescribe the drug; and

(2) A certified registered nurse practitioner who is:

(a) Authorized to practice under Health Occupations Article, Title 8, Subtitle 3, Annotated Code of Maryland; and

(b) Working with the physician in the same practice.