1882                                  LAWS OF MARYLAND                                Ch. 240

REGULATION THAT SPECIFIES HOW THE DRUG IS TO BE PACKAGED AND
REQUIRES THAT ITS LABEL BEAR £ STATEMENT OF PRECAUTIONS.

(II) THE SECRETARY MAY NOT ADOPT A RULE OR
REGULATION UNDER SUBPARAGRAPH (I) OF THIS PARAGRAPH BEFORE
THE SECRETARY HAS INFORMED THE APPROPRIATE BODY THAT IS
CHARGED WITH THE REVISION OF THE OFFICIAL COMPENDIUM OF THE
NEED FOR THE PACKAGING OR LABELING REQUIREMENTS AND THAT
BODY HAS FAILED TO ADOPT THE REQUIREMENTS WITHIN A
REASONABLE TIME.

REVISOR'S NOTE: This section is new language derived
without substantive change from former Article
43, § 189B(4), (5), (8), (9), (10), (12), (13),
(14), and (15).

Some of the professional people with whom the
Commission to Revise the Annotated Code conferred
in drafting this subtitle believe that the label
requirements set forth in subsection (b)(1) of
this section should apply to any prescription
drug. The General Assembly, therefore, may wish
to amend this section. If subsection (b)(1) is
amended to apply to any prescription drug,
subsection (d)(1) of this section should be
repealed as unnecessary.

The provisions of former Article 43, § 189(10),
revised as subsection (b)(7) through (10) of this
section, were limited expressly to apply to drugs
only. The revision of those provisions under
this section, which applies only to drugs,
retains this limited application. However, the
concerns addressed by these provisions also may
be applicable to devices. The General Assembly,
therefore, may wish to transfer these provisions
to be included under § 4-217(b) of this subtitle,
which would have the effect of making the
provisions applicable to both drugs and devices.

As to the reference to the Federal Act in
subsection (b)(ll) of this section, see 21 U.S.C.
356.

In subsection (b)(13) of this section, the
reference to a finding under § 4-239 of this
subtitle is substituted for the reference to the
Federal Act. While, ultimately, the
determination of whether a color additive is to
be considered safe in this State is most apt to
be made under the Federal Act, that determination
may be made by the Secretary under this subtitle.
Section 4-239 of this subtitle sets forth the
process by which a determination is made under
either the Federal Act or this subtitle.