HARRY HUGHES, Governor

1891

(2)  THE MANUFACTURER OF A NEW DRUG THAT IS
PROPOSED TO BE DISTRIBUTED TO INVESTIGATORS FOR CLINICAL
TESTING OR THE SPONSOR OF THE INVESTIGATION OBTAIN A SIGNED
AGREEMENT FROM EACH INVESTIGATOR WHO IS INVOLVED THAT:

(I)  THE PATIENTS TO WHOM THE DRUG IS
ADMINISTERED WILL BE UNDER THAT INVESTIGATOR'S PERSONAL
SUPERVISION OR UNDER THE SUPERVISION OF AN INVESTIGATOR WHO
IS RESPONSIBLE TO THAT INVESTIGATOR; AND

(II)  THE INVESTIGATOR WILL NOT SUPPLY THE
DRUG TO ANY OTHER INVESTIGATOR, OR TO ANY CLINIC, FOR
ADMINISTRATION TO A HUMAN BEING; AND

(3)  THE MANUFACTURER OF A NEW DRUG OR THE
SPONSOR OF THE INVESTIGATION OF THE DRUG KEEP RECORDS OF,
AND MAKE REPORTS TO THE SECRETARY OF, THE INFORMATION
OBTAINED FROM THE INVESTIGATIONAL USE OF THE DRUG, INCLUDING
ANALYTICAL REPORTS BY INVESTIGATORS, AS THE SECRETARY FINDS
WILL ASSIST IN THE EVALUATION OF THE SAFETY AND
EFFECTIVENESS OF THE DRUG IF AN APPLICATION FOR THE DRUG IS
FILED UNDER § 4-223 OF THIS SUBTITLE.

(C)  MANDATORY CONSIDERATIONS FOR THE ADOPTION OF RULES
AND REGULATIONS;.

(1)  WHEN ADOPTING A RULE OR REGULATION THAT
REQUIRES THE SUBMISSION OF INFORMATION UNDER THIS
SUBSECTION, THE SECRETARY SHALL CONSIDER THE PROFESSIONAL
ETHICS OF THE MEDICAL PROFESSION AND THE INTERESTS OF
PATIENTS.

(2)  ANY RULE, REGULATION, OR ORDER UNDER THIS
SECTION SHALL PROVIDE THAT IF ANY PERSON TO WHOM THE RULE,
REGULATION, OR ORDER APPLIES REQUESTS IT, AND IF THE
SECRETARY CONSIDERS IT TO BE APPROPRIATE, THE PERSON MAY
EXAMINE ANY SIMILAR INFORMATION THAT IS OBTAINED BY THE
SECRETARY CONCERNING THE DRUG.

(D)  AUTOMATIC ADOPTION OF FEDERAL RULES AND
REGULATIONS; INCONSISTENT STATE RULES AND REGULATIONS.

(1)  ANY RULE OR REGULATION ADOPTED UNDER §
355(I) OF THE FEDERAL ACT AUTOMATICALLY SHALL BE A RULE OR
REGULATION OF THIS STATE, AS PROVIDED IN § 4-241 OF THIS
SUBTITLE.

(2)  HOWEVER, THE SECRETARY MAY ADOPT A RULE OR
REGULATION UNDER THIS SECTION EVEN IF IT IS JOT IN ACCORD
WITH THE RULES AND REGULATIONS ADOPTED UNDER THE FEDERAL
ACT.

REVISOR'S NOTE: This section is new language derived
without substantive change from former Article
43, § 189D(d) and the last clause of (e)(1).