HARRY HUGHES, Governor                               1881

(II)  THE FORMULA OF THE DRUG SHOWING
QUANTITATIVELY EACH INGREDIENT OF THE DRUG TO THE EXTENT
REQUIRED FOR LABELS UNDER THE FEDERAL ACT; AND

(III)  A BRIEF SUMMARY OF ANY OTHER
INFORMATION THAT RELATES TO THE SIDE EFFECTS,
CONTRAINDICATIONS, OR EFFECTIVENESS OF THE DRUG, AS IS
REQUIRED BY THE RULES AND REGULATIONS ADOPTED UNDER THE
FEDERAL ACT.

(C)  APPLICATION OF REQUIREMENTS FOR DRUGS RECOGNIZED
IN AN OFFICIAL COMPENDIUM.

(1)  FOR PURPOSES OF SUBSECTION (B)(5) OF THIS
SECTION, WHICH IMPOSES PACKAGING AND LABELING REQUIREMENTS
ON ANY DRUG THAT IS PURPORTED TO BE RECOGNIZED IN AN
OFFICIAL COMPENDIUM, THE PROVISIONS OF THIS SUBSECTION SHALL
APPLY.

(2) (I) EXCEPT AS OTHERWISE PROVIDED IN THIS
SUBSECTION, IF THE DRUG IS RECOGNIZED IN BOTH THE UNITED
STATES PHARMACOPOEIA AND NATIONAL FORMULARY AND IN THE
HOMEOPATHIC PHARMACOPOEIA OF THE UNITED STATES, IT IS
SUBJECT TO THE PACKAGING AND LABELING REQUIREMENTS OF THE
UNITED STATES PHARMACOPOEIA AND NATIONAL FORMULARY.

(II) IF THE DRUG IS LABELED AND OFFERED
FOR SALE AS A HOMEOPATHIC DRUG, IT IS SUBJECT TO THE
PACKAGING AND LABELING REQUIREMENTS OF THE HOMEOPATHIC
PHARMACOPOEIA OF THE UNITED STATES AND NOT TO THE
REQUIREMENTS OF THE UNITED STATES PHARMACOPOEIA AND NATIONAL
FORMULARY.

(3)  IF THERE IS AN INCONSISTENCY BETWEEN THE
PROVISIONS OF PARAGRAPH (2) OF THIS SUBSECTION AND THE
REQUIREMENTS OF SUBSECTION (B)(2), (3), OR (4) OF THIS
SECTION AS TO THE NAME BY WHICH A DRUG OR ITS INGREDIENTS
SHALL BE DESIGNATED, THE REQUIREMENTS OF SUBSECTION (B)(2),
(3), OR (4) OF THIS SECTION CONTROL.

(D)  RULES AND REGULATIONS ON MISBRANDED DRUGS.

(1)  FOR PURPOSES OF SUBSECTION (B)(1) OF THIS
SECTION, AFTER INVESTIGATION, THE SECRETARY MAY ADOPT A RULE
OR REGULATION THAT DESIGNATES ANY CHEMICAL DERIVATIVE OF ANY
SUBSTANCE NAMED IN THAT SUBSECTION AS HABIT FORMING.

(2)  IF, AS TO A PARTICULAR DRUG, COMPLIANCE WITH
ANY REQUIREMENT OF SUBSECTION (B)(3) OR (4) OF THIS SECTION
IS IMPRACTICAL, THE SECRETARY SHALL ADOPT A RULE OR
REGULATION THAT, TO THE EXTENT APPROPRIATE, EXEMPTS THE DRUG
FROM THE PROVISIONS OF THOSE SUBSECTIONS.

(3)  (I) IF THE SECRETARY FINDS THAT A DRUG IS
LIABLE TO DETERIORATION, THE SECRETARY MAY ADOPT A RULE OR