HARRY HUGHES, Governor

1861

(I)  THE NAME DESIGNATED UNDER THE FEDERAL
ACT;

(II)  IF A NAME HAS NOT BEEN DESIGNATED
UNDER THE FEDERAL ACT, BUT THE DRUG OR INGREDIENT HAS BEEN
RECOGNIZED IN AN OFFICIAL COMPENDIUM, THEN THE TITLE USED IN
THE COMPENDIUM; OR

(III)  IF A NAME CAN NOT BE DETERMINED
UNDER ITEMS(I) OR(II) OF THIS PARAGRAPH, THE COMMON OR USUAL
NAME OF THE DRUG OR INGREDIENT.

(2) IN APPLYING THE PROVISIONS OF PARAGRAPH
(1)(II) OF THIS SUBSECTION, IF A DRUG OR AN INGREDIENT OF A
DRUG IS RECOGNIZED IN BOTH THE UNITED STATES PHARMACOPOEIA
AND NATIONAL FORMULARY AND IN THE HOMEOPATHIC PHARMACOPOEIA
OF THE UNITED STATES UNDER DIFFERENT OFFICIAL TITLES, THE
TITLE USED IN THE UNITED STATES PHARMACOPOEIA AND NATIONAL
FORMULARY IS THE ESTABLISHED NAME, UNLESS THE DRUG IS
LABELED AND OFFERED FOR SALE AS A HOMEOPATHIC DRUG, IN WHICH
EVENT THE OFFICIAL TITLE USED IN THE HOMEOPATHIC
PHARMACOPOEIA OF THE UNITED STATES IS THE ESTABLISHED NAME.

REVISOR'S NOTE: This subsection is new language derived
without substantive change from former Article
43, § 189B(6).

(D)  NEW DRUG.

"NEW DRUG" MEANS ANY DRUG THAT:

(1)  AMONG EXPERTS QUALIFIED BY SCIENTIFIC
TRAINING AND EXPERIENCE TO EVALUATE THE SAFETY AND
EFFECTIVENESS OF DRUGS, IS NOT RECOGNIZED GENERALLY AS SAFE
AND EFFECTIVE FOR USE UNDER THE CONDITIONS SPECIFIED,
RECOMMENDED, OR SUGGESTED IN THE LABELING OF THE DRUG; OR

(2)  AS A RESULT OF INVESTIGATIONS TO DETERMINE
ITS SAFETY AND EFFECTIVENESS FOR USE, HAS BECOME RECOGNIZED
BY THESE EXPERTS AS SAFE AND EFFECTIVE UNDER THE CONDITIONS,
BUT THAT, OTHER THAN IN THE INVESTIGATIONS, HAS NOT BEEN
USED TO A MATERIAL EXTENT OR FOR A MATERIAL TIME UNDER THE
CONDITIONS.

REVISOR'S NOTE: This subsection is new language derived
without substantive change from former Article
43, § 187A(r).

(E)  PRESCRIPTION DRUG.

"PRESCRIPTION DRUG" MEANS A DRUG THAT, UNDER § 4-220 OF
THIS SUBTITLE, MAY BE DISPENSED ONLY ON THE PRESCRIPTION OF
A HEALTH PRACTITIONER WHO IS AUTHORIZED BY LAW TO PRESCRIBE
THE DRUG.