HARRY HUGHES, Governor

1887

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

In accordance with apparent legislative intent,
this section as revised is broadened to address
requirements of law with respect to any
controlled dangerous substance, rather than
merely with respect to marijuana and narcotics.
This revision is called to the attention of the
General Assembly.

4-223. NEW DRUGS.

(A)  SCOPE OF SECTION.

THIS SECTION DOES NOT APPLY TO ANY DRUG THAT:

(1)  WAS SOLD IN THIS STATE OR INTRODUCED INTO
INTERSTATE COMMERCE AT ANY TIME BEFORE THE ENACTMENT OF THE
FEDERAL ACT, IF ITS LABELING CONTAINED THE SAME
REPRESENTATIONS CONCERNING THE CONDITIONS OF ITS USE; OR

(2)  IS LICENSED UNDER THE PUBLIC HEALTH SERVICE
ACT OF JULY 1, 1944 OR UNDER THE ANIMAL VIRUS-SERUM-TOXIN
ACT OF MARCH 4, 1913.

(B)  PROHIBITIONS.

A PERSON MAY NOT SELL, GIVE AWAY, OR DELIVER ANY NEW
DRUG:

(1)  UNLESS AN APPROVED APPLICATION FOR THE DRUG
IS IN EFFECT UNDER § 355 OF THE FEDERAL ACT; OR

(2)  UNLESS AN APPLICATION HAS BEEN APPROVED BY
THE SECRETARY AND IS IN EFFECT UNDER THIS SECTION, IF THE
DRUG IS NOT SUBJECT TO THE FEDERAL ACT.

(C)  FILING OF APPLICATION WITH SECRETARY.

TO HAVE AN APPLICATION APPROVED BY THE SECRETARY, AN
APPLICANT SHALL FILE WITH THE SECRETARY AN APPLICATION THAT
SETS FORTH:

(1)  FULL REPORTS OF THE INVESTIGATIONS THAT HAVE
BEEN MADE TO SHOW WHETHER THE DRUG IS SAFE FOR USE AND
WHETHER THE DRUG IS EFFECTIVE IN USE;

(2)  A FULL STATEMENT OF THE COMPOSITION OF THE
DRUG;

(3)  A FULL DESCRIPTION OF THE METHODS USED IN,
AND THE FACILITIES AND CONTROLS USED FOR, THE MANUFACTURE,
PROCESSING, AND PACKING OF THE DRUG;