HARRY HUGHES, Governor

1883

In subsection (c) of this section, references to
the "United States Pharmacopeia and National
Formulary" are substituted for the language that
refers to the "United States Pharmacopeia".
These publications have merged since former
Article 43, § 189B was enacted.

As to the reference to the Federal Act in
subsection (b)(12) of this section, see 21 U. S.
C. 357 (c) and (d).

For 2 additional conditions under which a drug is
misbranded, see § 4-220(d) and (e) of this
subtitle.

4-219. EXEMPTIONS FROM LABELING AND PACKAGING REQUIREMENTS
FOR DRUGS AND DEVICES SUBJECT TO ADDITIONAL PROCESSING,
LABELING, OR PACKING.

(A)  APPLICATION OF SECTION.

A DRUG OR DEVICE IS NOT SUBJECT TO THE LABELING OR
PACKAGING REQUIREMENTS OF THIS SUBTITLE IF A RULE OR
REGULATION IS ADOPTED UNDER THE FEDERAL ACT OR AS PROVIDED
UNDER THIS SECTION TO EXEMPT IT.

(B)  RULES AND REGULATIONS ADOPTED BY SECRETARY.

THE SECRETARY SHALL ADOPT RULES AND REGULATIONS TO
EXEMPT FROM THE LABELING REQUIREMENTS OF THIS SUBTITLE ANY
DRUG OR DEVICE THAT IS TO BE TRANSPORTED IN SUBSTANTIAL
QUANTITIES FROM ONE ESTABLISHMENT TO ANOTHER, IF IN
ACCORDANCE WITH THE PRACTICE OF THE TRADE, THE DRUG OR
DEVICE IS TO BE PROCESSED, LABELED, OR REPACKED AT THE
SECOND ESTABLISHMENT.

REVISOR'S NOTE: This section is new language derived
without substantive change from former Article
43, § 189B(17).

4-220. PRESCRIPTION REQUIREMENTS.

(A) IN GENERAL.

A DRUG THAT IS INTENDED FOR USE BY HUMAN BEINGS AND IS
IN ANY OF THE FOLLOWING CLASSIFICATIONS MAY BE DISPENSED BY
A PHARMACIST ONLY ON A WRITTEN OR ORAL PRESCRIPTION FROM A
HEALTH PRACTITIONER AUTHORIZED BY LAW TO PRESCRIBE THE DRUG:

(1)  A HABIT-FORMING DRUG TO WHICH § 4-218(B)(1)
OF THIS SUBTITLE APPLIES.

(2)  A DRUG THAT BECAUSE OF ITS TOXICITY OR OTHER
POTENTIALITY FOR HARMFUL EFFECT, THE METHOD OF ITS USE, OR