1286                             Laws of Maryland                      [Ch. 405

(12)  If it is a color additive unless its packaging and labeling
are in conformity with the packaging and labeling requirements
applicable to the color additive prescribed under the provisions of
the federal act.

(13)  If, after its manufacturing or processing or packaging, the
food was in a frozen state and if it is being offered for sale in an
unfrozen state unless the labeling clearly and conspicuously states
that the food should not be refrozen.

188F.

(a)  Any added poisonous or deleterious substance, any food addi-
tive, and any color additive, shall with respect to any particular
use or intended use, be deemed unsafe for the purpose of the appli-
cation of clause (ii) of Section 188B (1) with respect to any food,
Section 189A [(a)] with respect to any drug or device, or Section
190A [(1)] with respect to any cosmetic, unless there is in effect
a regulation pursuant to Section 191B of this subheading or sub-
section (b) of this section limiting the permissible quantity of such
substance with respect to the use, and the use or intended use of
the substance conforms to the terms prescribed by the regulation.
While the regulations relating to the substance are in effect, a food,
drug, or cosmetic shall not, by reason of bearing or containing such
substance in accordance with the regulations, be considered adul-
terated within the meaning of clause (i) of Section 188B (1), Section
189A (1); or Section 190A (1).

189C.

(b)  Any drug dispensed by filling or refilling a written or oral
prescription of a practitioner licensed by law to administer such
drug shall be exempt from the requirements of Section 189B, except
[paragraphs] subsections (1), (10) (b), (10) (c), (12), and (13)
thereof, and the packaging requirements of subsections (8) and (9)
thereof, if the drug bears a label containing the name and address
of the dispenser, the serial number and date of the prescription or
of its filling, the name of the prescriber and, if stated in the pre-
scription, the name of the patient, and the directions for use and
cautionary statements, if any, contained in such prescription. This
exemption shall not apply to any drugs dispensed in the course of
the conduct of a business of dispensing drugs pursuant to diagnosis
by mail, or to a drug dispensed in violation of subsection (a) of
this section.

189D.

(g) This section shall not apply:

(1)  To a drug sold in this State or introduced into interstate
commerce at any time prior to the enactment of the federal act,
if its labeling contained the same representations concerning the
conditions of its use; or

(2)  To any drug which is licensed under the Public Health Serv-
ice Act of July 1, 1944 (58 Stat. 682, as amended; 42 U.S.C. 201
et seq.) or under the animal virus-serum-toxin act of March 4, 1913
(13 Stat. 832; 21 U.S.C. 151 et seq.), as either of said acts have
been or may be amended from time to time; or