HARRY HUGHES, Governor

1879

(2)  IT HAS AN ESTABLISHED NAME AND, TO THE
EXCLUSION OF ANY OTHER NONPROPRIETARY NAME EXCEPT THE
APPLICABLE SYSTEMATIC CHEMICAL NAME OR THE CHEMICAL FORMULA
OF THE DRUG, ITS LABEL DOES NOT BEAR THE ESTABLISHED NAME OF
THE DRUG;

(3)  EXCEPT AS OTHERWISE PERMITTED BY A RULE OR
REGULATION ADOPTED UNDER THE FEDERAL ACT OR BY THE SECRETARY
UNDER SUBSECTION (D)(2) OF THIS SECTION, IT IS MADE FROM 2
OR MORE INGREDIENTS AND ITS LABEL DOES NOT BEAR THE
ESTABLISHED NAME, IF ANY, OF AND THE QUANTITY OF EACH ACTIVE
INGREDIENT, INCLUDING THE KIND AND QUANTITY OR PROPORTION OF
ANY ALCOHOL AND, WHETHER ACTIVE OR NOT, THE ESTABLISHED NAME
AND QUANTITY OR PROPORTION OF ANY BROMIDES, ETHER,
CHLOROFORM, ACETANILID, ACETOPHENETIDIN, AMIDOPYRINE,
ANTIPYRINE, ATROPINE, HYOSCINE, HYOSCYAMINE, ARSENIC,
DIGITALIS, DIGITALIS GLUCOSIDES, MERCURY, OUABAIN,
STROPHANTHIN, STRYCHNINE, THYROID, OR ANY DERIVATIVE OR
PREPARATION OF ANY OF THESE SUBSTANCES, BUT A
NONPRESCRIPTION DRUG IS NOT MISBRANDED UNDER THIS ITEM ON
THE GROUND THAT ITS LABEL DOES NOT SHOW THE QUANTITY OR
PROPORTION OF AN ACTIVE INGREDIENT UNLESS THE INGREDIENT IS
SPECIFICALLY NAMED IN THIS ITEM;

(4)  EXCEPT AS OTHERWISE PERMITTED BY A RULE OR
REGULATION ADOPTED UNDER THE FEDERAL ACT OR BY THE SECRETARY
UNDER SUBSECTION (D)(2) OF THIS SECTION, IT IS A
PRESCRIPTION DRUG, AND THE ESTABLISHED NAME OF THE DRUG AND
ANY OF ITS INGREDIENTS ARE NOT:

(I)  PRINTED PROMINENTLY ON THE LABEL OF
THE DRUG IN TYPE AT LEAST HALE AS LARGE AS THAT USED TO
PRINT ANY PROPRIETARY NAME OR OTHER DESIGNATION OF THE DRUG
OR OF ITS INGREDIENTS; AND

(II)  PRINTED IN THIS SAME MANNER ON ANY
LABELING OF THE DRUG ON WHICH ANY NAME FOR THE DRUG OR FOR
AN INGREDIENT IS USED;

(5)  IT PURPORTS TO BE A DRUG WHOSE NAME IS
RECOGNIZED IN AN OFFICIAL COMPENDIUM AND IT IS NOT:

(I)  LABELED AS REQUIRED BY THE APPLICABLE
OFFICIAL COMPENDIUM; OR

(II)  PACKAGED AS REQUIRED BY:

1.  THE APPLICABLE OFFICIAL
COMPENDIUM; OR

2.  A CONSENT ORDER GRANTED UNDER THE
FEDERAL ACT OR BY THE SECRETARY TO MODIFY THE PACKAGING
REQUIREMENTS OF THE OFFICIAL COMPENDIUM;