Introduced by Senator Campbell of Windsor District
Subject: Health; pharmaceuticals; wholesale; licensure
Statement of purpose: This bill proposes to require wholesale drug distributors to maintain a drug pedigree identifying the chain of distribution of the drug.
AN ACT RELATING TO PRESCRIPTION DRUG PEDIGREES
It is hereby enacted by the General Assembly of the State of Vermont:
Sec. 1. 26 V.S.A. § 2068 is amended to read:
§ 2068. REQUIREMENTS; APPLICANTS; LICENSEES
An applicant shall satisfy the board that it has, and licensees shall maintain, the following:
(1) Acceptable storage and handling conditions plus facilities standards.
(2) Minimum liability and other insurance as may be required under any applicable federal or state law.
(3) A security system which includes after hours, central alarm or comparable entry detection capability, restricted premises access, adequate outside perimeter lighting, comprehensive employment applicant screening, and safeguards against employee theft.
electronic, manual or any other reasonable system of records, describing all
wholesale distributor activities governed by this subchapter for the two-year
period following disposition of each product which shall be reasonably
accessible, as defined by the board by rule, during any inspection authorized
by the board. Inventories and
records of all transactions regarding the receipt and distribution or other
disposition of prescription drugs, including pedigrees for all prescription
drugs described by section 2068a of this title that leave the normal
(5) Officers, directors, managers, and other persons in charge of wholesale drug distribution, storage, and handling, who shall at all times demonstrate and maintain their capability to conduct business according to sound financial practices as well as state and federal law.
(6) Complete, updated information about the applicant or licensee, which shall be provided the board. The information shall include all pertinent ownership and other key personnel and facilities information deemed necessary, by the board, for enforcement of this subchapter. Any changes in such information shall be submitted at the time of license renewal or within 12 months from the date of such change, whichever occurs first.
(7) Written policies and procedures which assure reasonable wholesale distributor preparation for, protection against, and handling of any facility security or operation problems, including those caused by natural disaster or government emergency, inventory inaccuracies or product shipping and receiving, outdated product or other unauthorized product control, appropriate disposition of returned goods and product recalls.
(8) Sufficient inspection procedures for all incoming and outgoing product shipments.
(9) Operations in compliance with all federal requirements applicable to wholesale drug distribution.
Sec. 2. 26 V.S.A. § 2068a is added to read:
§ 2068a. PEDIGREES
(a) Each person who is in possession of a pedigree for a prescription drug shall affirmatively verify before distribution of a prescription drug that each transaction listed on the pedigree has occurred.
(b) The pedigree shall include:
(1) All necessary identifying information concerning each sale in the chain of distribution of the product from the manufacturer, through acquisition and sale by any wholesale distributor, until final sale to a pharmacy or other person dispensing or administering the drug. At minimum, the necessary chain of distribution information shall include:
(A) The name, address, telephone number, and if available, the e-mail address, of each owner of the prescription drug, and each wholesale distributor of the prescription drug;
(B) The name and address of each location from which the product was shipped, if different from the owner’s;
(C) Transaction dates; and
(D) Certification that each recipient has authenticated the pedigree; and
(2) The name of the prescription drug, the dosage form and strength of the prescription drug, the size of the container, the number of containers, the lot number of the prescription drug, and the name of the manufacturer of the finished dosage form.
(c) Each pedigree shall be:
(1) Maintained by the purchaser and the wholesale distributor for three years from the date of sale or transfer; and
(2) Available for inspection or use within two business days upon a request of an authorized police officer.
(d) The pharmacy board shall adopt rules and a form relating to the requirements of this subsection no later than 90 days after the effective date of this section.
Sec. 3. STUDY
The pharmacy board shall study the feasibility of an electronic pedigree system and shall report the findings and recommendations no later than January 15, 2007. The study shall include consultation with manufacturers, distributors, and pharmacies responsible for the sale and distribution of prescription drugs. The board shall include an implementation date in the report for electronic pedigrees.
The Vermont General Assembly
115 State Street