Minnesota Legislature
Office of the Revisor of Statutes
2007 Minnesota Statutes
This is an historical version of this statute chapter. Also view the most recent published version.
151.361 MANUFACTURER DISCLOSURE.
Subdivision 1. After January 1, 1976. The manufacturer, packager, or distributor of any
human use legend drug sold, delivered, or offered for sale in the state of Minnesota after January
1, 1976 must have printed on the label on the immediate container of the drug the name and
address of the manufacturer of the finished dosage form of the drug.
Subd. 2. After January 1, 1983. (a) No legend drug in solid oral dosage form may be
manufactured, packaged or distributed for sale in this state after January 1, 1983 unless it is
clearly marked or imprinted with a symbol, number, company name, words, letters, national drug
code or other mark uniquely identifiable to that drug product. An identifying mark or imprint
made as required by federal law or by the federal Food and Drug Administration shall be deemed
to be in compliance with this section.
(b) The Board of Pharmacy may grant exemptions from the requirements of this section
on its own initiative or upon application of a manufacturer, packager, or distributor indicating
size or other characteristics which render the product impractical for the imprinting required
by this section.
(c) The provisions of clauses (a) and (b) shall not apply to any of the following:
(1) Drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to January 1,
1983, and held in stock for resale.
(2) Drugs which are manufactured by or upon the order of a practitioner licensed by law to
prescribe or administer drugs and which are to be used solely by the patient for whom prescribed.
Subd. 3. Penalty. Failure to comply with the requirements of this section shall subject a drug
to embargo in accordance with section 151.38.
History: 1975 c 101 s 4; 1981 c 206 s 1
Subdivision 1. After January 1, 1976. The manufacturer, packager, or distributor of any
human use legend drug sold, delivered, or offered for sale in the state of Minnesota after January
1, 1976 must have printed on the label on the immediate container of the drug the name and
address of the manufacturer of the finished dosage form of the drug.
Subd. 2. After January 1, 1983. (a) No legend drug in solid oral dosage form may be
manufactured, packaged or distributed for sale in this state after January 1, 1983 unless it is
clearly marked or imprinted with a symbol, number, company name, words, letters, national drug
code or other mark uniquely identifiable to that drug product. An identifying mark or imprint
made as required by federal law or by the federal Food and Drug Administration shall be deemed
to be in compliance with this section.
(b) The Board of Pharmacy may grant exemptions from the requirements of this section
on its own initiative or upon application of a manufacturer, packager, or distributor indicating
size or other characteristics which render the product impractical for the imprinting required
by this section.
(c) The provisions of clauses (a) and (b) shall not apply to any of the following:
(1) Drugs purchased by a pharmacy, pharmacist, or licensed wholesaler prior to January 1,
1983, and held in stock for resale.
(2) Drugs which are manufactured by or upon the order of a practitioner licensed by law to
prescribe or administer drugs and which are to be used solely by the patient for whom prescribed.
Subd. 3. Penalty. Failure to comply with the requirements of this section shall subject a drug
to embargo in accordance with section 151.38.
History: 1975 c 101 s 4; 1981 c 206 s 1
Official Publication of the State of Minnesota
Revisor of Statutes