HARRY HUGHES, Governor

1875

(5)  THE METHODS, FACILITIES, OR CONTROLS USED IN
THE MANUFACTURE, PROCESSING, PACKING, OR HOLDING OF THE DRUG
DO NOT CONFORM TO, OR ARE NOT ADMINISTERED IN CONFORMITY TO,
GOOD PRACTICE TO ASSURE THAT THE DRUG:

(I)  MEETS THE REQUIREMENTS OF THIS
SUBTITLE AS TO SAFETY; AND

(II)  HAS THE IDENTITY, STRENGTH, QUALITY,
AND PURITY THAT IT PURPORTS TO HAVE;

(6)  IT IS PURPORTED TO BE A DRUG THE NAME OF
WHICH IS RECOGNIZED IN AN OFFICIAL COMPENDIUM AND:

(I)  THE STRENGTH OF THE DRUG DIFFERS FROM,
OR THE QUALITY OR PURITY OF THE DRUG FALLS BELOW, THE
STANDARD SET IN THE OFFICIAL COMPENDIUM; AND

(II)  THE DIFFERENCE IN STRENGTH, QUALITY,
OR PURITY IS NOT STATED PLAINLY ON ITS LABEL; OR

(7)  ALTHOUGH NOT PURPORTED TO BE A DRUG
RECOGNIZED IN AN OFFICIAL COMPENDIUM, THE STRENGTH OF THE
DRUG DIFFERS FROM, OR THE QUALITY OR PURITY OF THE DRUG
FALLS BELOW THAT WHICH THE DRUG PURPORTS TO POSSESS.

(D) TESTING DRUGS PURPORTED TO BE RECOGNIZED IN
OFFICIAL COMPENDIUM; APPLICATION OF REQUIREMENTS IN OFFICIAL
COMPENDIUM.

(1)  FOR PURPOSES OF ADMINISTERING SUBSECTION
(C)(6) OF THIS SECTION, ANY DETERMINATION AS TO WHETHER THE
STRENGTH OF A DRUG DIFFERS FROM OR AS TO WHETHER ITS QUALITY
OR PURITY FALLS BELOW THE STANDARD SET IN AN OFFICIAL
COMPENDIUM SHALL BE MADE IN ACCORDANCE WITH THE TESTS OR
METHODS OF ASSAY SET FORTH IN THE OFFICIAL COMPENDIUM, OR,
IN THE ABSENCE OF OR INADEQUACY OF THOSE TESTS OR METHODS OF
ASSAY, THOSE PROVIDED UNDER THE FEDERAL ACT.

(2) (I) EXCEPT AS PROVIDED IN SUBPARAGRAPH (II)
OF THIS PARAGRAPH, IF A 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 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
PROVISIONS OF THE HOMEOPATHIC PHARMACOPOEIA OF THE UNITED
STATES AND NOT TO THOSE OF THE UNITED STATES PHARMACOPOEIA
AND NATIONAL FORMULARY.

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