CHAPTER 154

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PROFESSIONS AND OCCUPATIONS

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HOUSE BILL 04-1308 [Digest]

BY REPRESENTATIVE(S) Cloer, Jahn, King, Paccione, Spradley, White, Lundberg, Boyd, Butcher, Fairbank, Miller, Mitchell, Carroll, Coleman, Hefley, Hoppe, McFadyen, Rose, and Stengel;

also SENATOR(S) Lamborn, Chlouber, and Evans.

AN ACT

Concerning the requirement of pedigree papers for the distribution of prescription drugs.

Be it enacted by the General Assembly of the State of Colorado:

  SECTION 1.  Legislative declaration - short title. (1)  The general assembly hereby finds, determines, and declares that counterfeit substances labeled as genuine pharmaceuticals may be distributed, thereby causing an extreme danger to persons eventually receiving the drugs by prescription because the drugs are ineffective, in doses that are not therapeutic, or even contain dangerous or unwholesome substances. Relabeled, falsely represented, and counterfeit drugs put the safety of the public at risk. Existing laws do not contain explicit tracking requirements to identify the source of these products. Therefore, based upon the widespread, known cases of counterfeit drugs in other states that have resulted in injury and death, it is necessary to create the provisions of this act.

  (2)  The provisions of this act shall be known and may be cited as the "Prescription Drug Protection Act".

  SECTION 2.  Part 1 of article 22 of title 12, Colorado Revised Statutes, is amended BY THE ADDITION OF A NEW SECTION to read:

  12-22-131.  Records. (1) (a)  All records of receipt, distribution, or other disposal of prescription drugs or controlled substances shall be available to the board upon request for inspection, copying, verification, or any other purpose. Such records shall be retained for two years.

  (b)  The board may permit a wholesaler to maintain a portion of its records at a central location that is different from the storage facility of the wholesaler. If such permission has been granted, the wholesaler shall make available all relevant records within forty-eight hours after a request for inspection, copying, verification, or any other purpose by the board. All other records that are available for immediate access shall be readily available to the board.

  (2)  A wholesale distributor shall establish and maintain inventories and records of all transactions regarding the receipt and distribution of prescription drugs. Availability of records maintained by a wholesale distributor shall be in accordance with the provisions of subsection (1) of this section. Such records shall include the following information:

  (a)  The source of the prescription drugs, including the name and principal address of the seller or transferor of the prescription drugs and the address of the location from which the prescription drugs were shipped;

  (b)  The identity and quantity of the drugs received, distributed, or disposed of by the wholesale distributor; and

  (c)  The dates of receipt, distribution, or other disposition of the prescription drugs.

  SECTION 3.  Effective date - applicability. This act shall take effect July 1, 2004, and shall apply to the distribution of any prescription drug on or after said date.

  SECTION 4.  Safety clause. The general assembly hereby finds, determines, and declares that this act is necessary for the immediate preservation of the public peace, health, and safety.

Approved: April 13, 2004

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Capital letters indicate new material added to existing statutes; dashes through words indicate deletions from existing statutes and such material not part of act.

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