1888                                  LAWS OF MARYLAND                                Ch. 240

(4)  ANY SAMPLE OF THE DRUG AND OF ANY ARTICLE
USED AS A COMPONENT OF THE DRUG THAT THE SECRETARY REQUIRES;
AND

(5)  A SPECIMEN OF THE LABELING THAT IS PROPOSED
TO BE USED FOR THE DRUG.

(D)  STANDARD FOR APPROVAL.

THE SECRETARY MAY NOT APPROVE AN APPLICATION FILED
UNDER THIS SECTION UNLESS THE DRUG HAS BEEN TESTED AND,
UNDER THE CONDITIONS SPECIFIED, RECOMMENDED, OR SUGGESTED IN
THE PROPOSED LABELING OF THE DRUG, HAS BEEN FOUND TO BE SAFE
FOR AND EFFECTIVE IN USE.

(E)  AUTOMATIC APPROVAL OF APPLICATIONS; PROCEDURE AND
GROUNDS FOR DISAPPROVAL.

AN APPLICATION FILED WITH THE SECRETARY UNDER THIS
SECTION SHALL BE CONSIDERED APPROVED ON THE 180TH DAY AFTER
IT IS FILED, UNLESS BEFORE THAT DAY AND AFTER GIVING THE
APPLICANT NOTICE AND AN OPPORTUNITY FOR A HEARING, THE
SECRETARY ISSUES AN ORDER OF DISAPPROVAL UNDER SUBSECTION
(F) OF THIS SECTION ON A FINDING THAT:

(1)  THE DRUG HAS NOT BEEN TESTED PROPERLY, AS
REQUIRED BY SUBSECTION (D) OF THIS SECTION;

(2)  UNDER THE CONDITIONS SPECIFIED, RECOMMENDED,
OR -SUGGESTED IN THE PROPOSED LABELING OF THE DRUG, IT IS NOT
SAFE FOR OR EFFECTIVE IN USE;

(3)  THE METHODS USED IN, AND THE FACILITIES AND
CONTROLS USED FOR, THE MANUFACTURE, PROCESSING, AND PACKING
OF THE DRUG ARE INADEQUATE TO PRESERVE ITS IDENTITY,
STRENGTH, QUALITY, AND PURITY; OR

(4)  BASED ON A FAIR EVALUATION OF ALL MATERIAL
FACTS, THE PROPOSED LABELING IS FALSE OR MISLEADING IN ANY
WAY.

(F)  ORDER OF DISAPPROVAL.

IF, BEFORE THE DATE THAT THE APPLICATION OTHERWISE
WOULD BE CONSIDERED APPROVED THE SECRETARY MAKES ANY OF THE
FINDINGS THAT ARE ENUMERATED IN SUBSECTION (E) OF THIS
SECTION CONCERNING THE DRUG, THE SECRETARY SHALL ISSUE AN
ORDER THAT DISAPPROVES THE APPLICATION.

(G)  REVOCATION OF DISAPPROVAL; REVOCATION OF APPROVAL.

(1) THE SECRETARY MAY REVOKE AN ORDER THAT
DISAPPROVED AN APPLICATION AND THE APPLICATION THEN SHALL BE
CONSIDERED APPROVED.