Connecticut Seal

General Assembly

Amendment

 

February Session, 2010

LCO No. 5721

   
 

*SB0042805721SDO*

Offered by:

 

SEN. HARRIS, 5th Dist.

REP. RITTER, 38th Dist.

 

To: Subst. Senate Bill No. 428

File No. 379

Cal. No. 271

After the last section, add the following and renumber sections and internal references accordingly:

"Sec. 501. (NEW) (Effective October 1, 2010) As used in sections 501 and 502 of this act:

(1) "Biologic" means a "biological product", as defined in 42 USC 262(i), as amended from time to time, that is regulated as a drug under the federal Food, Drug and Cosmetic Act, 21 USC 301 et seq. ;

(2) "Department" means the Department of Consumer Protection;

(3) "Medical device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, that is: (A) Recognized in the official National Formulary or the United States Pharmacopeia or any supplement thereto; (B) intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, in persons or animals; or (C) intended to affect the structure or function of the body of a person or animal, and that does not achieve its primary intended purposes through chemical action within or on such body and that is not dependent upon being metabolized for the achievement of its primary intended purposes; and

(4) "Pharmaceutical or medical device manufacturing company" means any entity that: (A) Is engaged in the production, preparation, propagation, compounding, conversion or processing of prescription drugs, biologics or medical devices, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis; or (B) is directly engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs, biologics or medical devices. "Pharmaceutical or medical device manufacturing company" does not include a health care provider, physician practice, home health agency, hospital licensed in this state, wholesale drug distributor licensed in this state or a retail pharmacy licensed in this state.

Sec. 502. (NEW) (Effective October 1, 2010) (a) On or before January 1, 2011, each pharmaceutical or medical device manufacturing company shall adopt and implement a code that is consistent with, and minimally contains all of the requirements prescribed in, the Pharmaceutical Research and Manufacturers of America's "Code on Interaction with Healthcare Professionals" or AdvaMed's "Code of Ethics on Interactions with Health Care Professionals" as such codes were in effect on January 1, 2010.

(b) Each pharmaceutical or medical device manufacturing company shall adopt a comprehensive compliance program in accordance with the guidelines provided in the "Compliance Program Guidance for Pharmaceutical Manufacturers" dated April, 2003 and issued by the United States Department of Health and Human Services Office of Inspector General.

(c) Upon complaint, the department may investigate an alleged (1) violation of subsection (a) of this section, or (2) failure to conduct any training program or regular audit for compliance with the code adopted pursuant to subsection (a) of this section by a pharmaceutical or medical device manufacturing company. The Commissioner of Consumer Protection may impose a civil penalty of not more than five thousand dollars for any violation of the provisions of this section. "