43-15.3-06. Pedigree

43-15.3-06. Pedigree

1. Each person who is engaged in wholesale distribution of prescription drugs, including

repackagers but excluding the original manufacturer of the finished form of the

prescription drug which leave or have ever left the normal distribution channel, before

each wholesale distribution of the drug, must provide a pedigree to the person who

receives the drug.

a. A retail pharmacy or chain pharmacy warehouse must comply with the

requirements of this section only if the pharmacy or chain pharmacy warehouse

engages in wholesale distribution of prescription drugs.

b. The board shall determine by July 1, 2009, a targeted implementation date for

electronic track and trace pedigree technology. The determination must be based

on consultation with manufacturers, distributors, and pharmacies responsible for

the sale and distribution of prescription drug products in this state. After

consultation with interested stakeholders and before implementation of the

electronic track and trace pedigree technology, the board must determine that the

technology is universally available across the entire prescription pharmaceutical

supply chain. The implementation date for the mandated electronic track and

trace pedigree technology may not be before July 1, 2010, and may be extended

by the board in one-year increments if it appears the technology is not universally

available across the entire prescription pharmaceutical supply chain.

2. Each person engaged in the wholesale distribution of a prescription drug, including a

repackager but excluding the original manufacturer of the finished form of the

prescription drug, that is provided a pedigree for a prescription drug and attempts to

further distribute that prescription drug shall verify affirmatively before any distribution

of a prescription drug occurs that each transaction listed on the pedigree has occurred.

3. The pedigree must:

a. Include all necessary identifying information concerning each sale in the chain of

distribution of the product from the manufacturer, or the manufacturer's third-party

logistics provider, colicensed product partner, or manufacturer's exclusive

distributor, through acquisition and sale by any wholesale distributor or

repackager, until final sale to a pharmacy or other person dispensing or

administering the drug. At minimum, the necessary chain of distribution

information must include:

(1) The name, address, telephone number, and if available, the electronic mail

address, of each owner of the prescription drug, and each wholesale

distributor of the prescription drug;

(2) The name and address of each location from which the product was

shipped, if different from the owner's;

(3) The transaction dates; and

(4) A certification that each recipient has authenticated the pedigree.

b. At minimum, the pedigree must also include the:

(1) Name of the prescription drug;

(2) Dosage form and strength of the prescription drug;

(3) Size of the container;

(4) Number of containers;

(5) Lot number of the prescription drug;

(6) Name of the manufacturer of the finished dosage form; and

(7) National drug code (NDC) number.

4. Each pedigree or electronic file must be:

a. Maintained by the purchaser and the wholesale distributor for three years from

the date of sale or transfer; and

b. Available for inspection or use within five business days upon a request of an

authorized officer of the law or the board.

5. The board shall adopt rules and a form relating to the requirements of this section.