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Session Laws, 1997
Volume 795, Page 3426   View pdf image
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Ch. 614

1997 LAWS OF MARYLAND

(3) THE CREATION OF A DIFFERENT, DISTINCT DOSAGE FORM, DOSE,
OR FORMULATION WHICH IS COMMERCIALLY UNAVAILABLE FOR USE BY HUMANS
OR ANIMALS PURSUANT TO AN AUTHORIZED PRESCRIBER'S PRESCRIPTION
WRITTEN FOR A SPECIFIC PATIENT; OR

(4) THE SELECTION OF NONTHERAPEUTIC INGREDIENTS TO BE
UTILIZED IN THE COMBINING OF CHEMICALS, PRESCRIPTION DRUGS, OR

NONPRESCRIPTION DRUGS WHEN THE NECESSARY NONTHERAPEUTIC

INGREDIENTS ARE NOT SPECIFIED IN THE AUTHORIZED PRESCRIBER'S
PRESCRIPTION.
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.

(2) "COMPOUNDING" INCLUDES THE PREPARATION OF DRUGS OR
DEVICES IN ANTICIPATION OF A PRESCRIPTION DRUG ORDER BASED ON ROUTINE,
REGULARLY OBSERVED PRESCRIBING PATTERNS.

[(d)](E) (1) "Device" means a device used in the diagnosis, treatment, or
prevention of disease.

(2) "Device" does not include any:

(i) Surgical or dental instrument;

(ii) Physical therapy equipment;

(iii) X-ray apparatus; or

(iv) Component part or accessory of any of these items.

(F) "DISPENSE" OR "DISPENSING" MEANS THE PROCEDURE WHICH RESULTS
IN THE RECEIPT OF A PRESCRIPTION OR NONPRESCRIPTION DRUG, OR DEVICE, OR
DIAGNOSTIC BY A PATIENT OR THE PATIENTS AGENT AND WHICH ENTAILS THE
INDEPENDENT:

(1)      INTERPRETATION OF AN AUTHORIZED PRESCRIBER'S
PRESCRIPTION FOR A DRUG; OR DEVICE, OR DIAGNOSTIC;

(2)      SELECTION AND LABELING OF THE DRUG, OR DEVICE, OR
DIAGNOSTIC PRESCRIBED PURSUANT TO THAT PRESCRIPTION; AND

(3)      MEASURING AND PACKAGING OF THE PRESCRIBED DRUG, OR
DEVICE, OR DIAGNOSTIC IN ACCORDANCE WITH STATE AND FEDERAL LAWS.

(G) (1) "DISTRIBUTE" MEANS THE PROCESS RESULTING IN THE PROVISION
OF A PRESCRIPTION OR NONPRESCRIPTION DRUG, OR DEVICE, OR DIAGNOSTIC TO A

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Session Laws, 1997
Volume 795, Page 3426   View pdf image
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