Illinois § 57

§ 57.

Pedigree. (a) Each person who is engaged in the wholesale distribution of prescription drugs, including repackagers, but excluding the original manufacturer of the finished form of the prescription drug, that leave or have ever left the normal distribution channel shall, before each wholesale distribution of the drug, provide a pedigree to the person who receives the drug. A retail pharmacy, mail order pharmacy, or chain pharmacy warehouse must comply with the requirements of this Section only if the pharmacy or chain pharmacy warehouse engages in the wholesale distribution of prescription drugs. On or before July 1, 2009, the Department shall determine a targeted implementation date for electronic track and trace pedigree technology. This targeted implementation date shall not be sooner than July 1, 2010. Beginning on the date established by the Department, pedigrees may be implemented through an approved and readily available system that electronically tracks and traces the wholesale distribution of each prescription drug starting with the sale by the manufacturer through acquisition and sale by any wholesale distributor and until final sale to a pharmacy or other authorized person administering or dispensing the prescription drug. This electronic tracking system shall be deemed to be readily available only upon there being available a standardized system originating with the manufacturers and capable of being used on a wide scale across the entire pharmaceutical chain, including manufacturers, wholesale distributors, third-party logistics providers, and pharmacies. Consideration must also be given to the large-scale implementation of this technology across the supply chain and the technology must be proven to have no negative impact on the safety and efficacy of the pharmaceutical product. (b) Each person who is engaged in the wholesale distribution of a prescription drug who is provided a pedigree for a prescription drug and attempts to further distribute that prescription drug, including repackagers, but excluding the original manufacturer of the finished form of the prescription drug, must affirmatively verify before any distribution of a prescription drug occurs that each transaction listed on the pedigree has occurred. (c) The pedigree must 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, co-licensed product partner, or 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. This necessary chain of distribution information shall include, without limitation all of the following: (1) 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. (2) The name and address of each location from which the product was shipped, if different from the owner's. (3) Transaction dates. (4) Certification that each recipient has authenticated the pedigree. (d) The pedigree must also include without limitation all of the following information concerning the prescription drug: (1) The name and national drug code number of the prescription drug. (2) The dosage form and strength of the prescription drug. (3) The size of the container. (4) The number of containers. (5) The lot number of the prescription drug. (6) The name of the manufacturer of the finished dosage form. (e) Each pedigree or electronic file shall be maintained by the purchaser and the wholesale distributor for at least 3 years from the date of sale or transfer and made available for inspection or use within 5 business days upon a request of the Department. (Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)