Section 333.7302a - Identification of certain prescription drugs and manufacturer or distributor; descriptive material; national registry of prescription drugs; exemptions; rules; “prescription drug”
PUBLIC HEALTH CODE (EXCERPT)
Act 368 of 1978
333.7302a Identification of certain prescription drugs and manufacturer or distributor; descriptive material; national registry of prescription drugs; exemptions; rules; “prescription drug” defined; violation as misdemeanor; penalty.
Sec. 7302a.
(1) A prescription drug that is in finished solid oral dosage form shall not be manufactured or distributed in this state after June 1, 1985 unless the drug is clearly and prominently marked or imprinted with an individual symbol, number, company name, words, letters, marking, national drug code, or a combination of any of the foregoing that identifies the prescription drug and the manufacturer or distributor of the drug.
(2) A person licensed by the administrator under this article to manufacture or distribute prescription drugs shall supply to the department of commerce descriptive material that will identify each current mark or imprint under subsection (1) used by the person who distributes or manufactures the prescription drug.
(3) It is the intent of the legislature that the descriptive material received by the department of commerce pursuant to subsection (2) shall be used in conjunction with similar information from other states by the United States department of health and human services, food and drug administration, or other national agency or organization, to compile a national registry of prescription drugs manufactured or distributed in the United States.
(4) The department of commerce, upon the application of a person who distributes or manufactures a prescription drug, shall exempt a particular prescription drug from the requirements of this section if the department of commerce determines that marking or imprinting the prescription drug is not feasible because of the drug's size, texture, or other unique characteristic.
(5) This section does not apply to a prescription drug that is compounded by a pharmacist licensed under article 15.
(6) The department of commerce may promulgate rules pursuant to the administrative procedures act of 1969, for purposes of implementing and enforcing this section.
(7) As used in this section, “prescription drug” means a prescription drug as defined in section 17708(4).
(8) A person who knowingly or intentionally violates this section is guilty of a misdemeanor, punishable by imprisonment for not more than 1 year, or a fine of not more than $25,000.00, or both.
History: Add. 1984, Act 254, Eff. Mar. 29, 1985 ;-- Am. 1993, Act 80, Eff. Apr. 1, 1994
Popular Name: Act 368