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Session Laws, 1982
Volume 742, Page 1892   View pdf image
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1892                                  LAWS OF MARYLAND                                Ch. 240

As to subsection (d)(1) of this section, § 355(i)
of the Federal Act provides that the Secretary of
Health and Human Services shall adopt regulations
to exempt from the federal requirements for new
drugs any new drug that is intended only for
investigational use and that otherwise meets the
requirements of any regulation adopted under that
section.

4-225. INSPECTION OF RECORDS REGARDING NEW DRUGS.

ANY PERSON WHO IS REQUIRED UNDER § 4-223 OR § 4-224 OF
THIS SUBTITLE TO KEEP RECORDS AND ANY PERSON WHO IS IN
CHARGE OR CUSTODY OF ANY OF THESE RECORDS, ON THE REQUEST OF
THE SECRETARY, SHALL PERMIT THE SECRETARY TO HAVE ACCESS TO,
COPY, AND VERIFY THE RECORDS AT ANY REASONABLE TIME.

REVISOR'S NOTE: This section is new language derived -
without substantive change from former Article
43, § 189D(e)(2).

4-226. PRINTED INFORMATION FOR USE OF PRACTITIONERS.

(A)  IN GENERAL.

THE MANUFACTURER, PACKER, OR DISTRIBUTOR OF ANY
PRESCRIPTION DRUG THAT IS SOLD OR DISTRIBUTED IN THIS STATE
SHALL:

(1)  KEEP CORRECT COPIES OF ANY PRINTED MATTER
THAT IS:

(I)  REQUIRED TO BE INCLUDED IN ANY PACKAGE
IN WHICH THE DRUG IS SOLD OR DISTRIBUTED; OR

(II)  APPROVED UNDER THE FEDERAL ACT; AND

(2)  SEND COPIES OF THE PRINTED MATTER TO ANY
HEALTH PRACTITIONER WHO IS AUTHORIZED TO ADMINISTER THE DRUG
AND WHO MAKES A WRITTEN REQUEST FOR INFORMATION ABOUT THE
DRUG.

(B)  CONSTRUCTION OF SECTION.

THIS SECTION DOES NOT EXEMPT ANY PERSON FROM ANY
LABELING REQUIREMENT IMPOSED UNDER ANY OTHER PROVISION OF
THIS SUBTITLE.

REVISOR'S NOTE: This section is new language derived
without substantive change from former Article
43, § 187B(14).

In subsection (a)(1) of this section, "sold" is
substituted for "offered for sale" in light of

 

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Session Laws, 1982
Volume 742, Page 1892   View pdf image
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