Md. Code Regs. 10.34.34.02

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

Section 10.34.34.02 - Definitions

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) "Board" means the State Board of Pharmacy.

(2) Compounding.

(a) "Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug or device:

(i) As the result of a practitioner's prescription drug order or initiative based on the practitioner/patient/pharmacist relationship in the course of professional practice; or

(ii) For the purpose of, or incident to, research, teaching, or chemical analysis and not for the sale or dispensing of the drug or device.

(b) "Compounding" includes the preparation of drugs or devices in anticipation of a prescription drug order based on routine, regularly observed prescribing patterns.

(3) Delegated Pharmacy Act.

(a) "Delegated pharmacy act" means an activity that constitutes the practice of pharmacy delegated by a licensed pharmacist under Health Occupations Article, Title 12, Subtitle 6B, Annotated Code of Maryland, and this chapter.

(b) "Delegated pharmacy act" does not include:

(i) An act within the parameters of a Drug Therapy Management contract as provided under Health Occupations Article, Subtitle 6A, Annotated Code of Maryland;

(ii) The delegation of a pharmacy act by a registered pharmacy technician, pharmacy student, or pharmacy technician trainee;

(iii) A pharmacy activity performed by a pharmacy student in accordance with Health Occupations Article, § 12-301(b), Annotated Code of Maryland; or

(iv) A pharmacy activity performed by an applicant for a license to practice pharmacy, if the applicant does not perform delegated pharmacy acts for more than 10 months.

(4) "Direct supervision" means that a licensed pharmacist is physically available onsite to supervise the performance of delegated pharmacy acts.

(5) "Experiential learning rotation" means a course offered by an Accreditation Council for Pharmacy Education accredited school of pharmacy that is designed to provide pharmacy practice experiences to students seeking the doctor of pharmacy degree.

(6) Final Product Verification.

(a) "Final product verification" means:

(i) Confirming the accuracy of the device or drug product, and dosage form of a filled prescription or medication order; or

(ii) Confirming the accuracy of the device or drug product, and dosage form of a prescription or medication selected for stocking into a medication distribution system.

(b) "Final product verification" does not include determining the appropriateness of the prescription device or drug product, dosage form, directions for use, labeling, packaging, or any other determination that requires the application of a pharmacist's clinical expertise.

(7) "Medication distribution system" means an automated medication system, emergency box, interim box, medication carousel or cart, or other storage and dispensing system.

(8) "National pharmacy technician certification program" means a program approved by a Board-recognized national accrediting body.

(9) "Pharmacy student" means an individual who is enrolled as a student in a school or college of pharmacy approved by the Board or accredited by the Accreditation Council for Pharmacy Education.

(10) "Pharmacy technician trainee" means an individual engaged in a Board-approved pharmacy technician training program.

(11) "Registered pharmacy technician" means an individual who is registered with the Board to perform delegated pharmacy acts.

(12) "Registration" means, unless the context requires otherwise, a registration issued by the Board to perform delegated pharmacy acts under the direct supervision of a licensed pharmacist.

(13) "Supervision" means reviewing the work, guiding and directing the activities, and monitoring the performance of an individual.

(14) "Unit dose" means a package labeled with bar code scanning or other similar technology containing a single dose of a device, drug, or medication ordered or prescribed for a patient.

(15) "Unit-of-use" means a package or container, such as a unit dose (injectable, liquid, or solid), otic, ophthalmic product, otic product, topical product, or a prescription vial filled from a stock bottle or in the original manufacturer's packaging, designed to be dispensed to a patient that is labeled with bar code scanning or other similar technology.

(16) "Validated pharmacy technician" means a registered pharmacy technician who has obtained a product verification certificate issued by a Board-approved national training program and satisfied other regulatory requirements.

Md. Code Regs. 10.34.34.02

Regulations .02 amended effective 50:26 Md. R. 1132, eff. 1/8/2024; amended effective 51:22 Md. R. 957-1028, eff. 11/11/2024.