2011 California Code
Business and Professions Code
DIVISION 2. HEALING ARTS [500 - 4999.122]
ARTICLE 11. Wholesalers and Manufacturers
Section 4163.3

(a) It is the intent of the Legislature that participants in the distribution chain for dangerous drugs, including manufacturers, wholesalers, or pharmacies furnishing, administering, or dispensing dangerous drugs, distribute and receive electronic pedigrees, and verify and validate the delivery and receipt of dangerous drugs against those pedigrees at the unit level, in a manner that maintains the integrity of the pedigree system without an unacceptable increase in the risk of diversion or counterfeiting.

(b) To meet this goal, and to facilitate efficiency and safety in the distribution chain, the board shall, by regulation, define the circumstances under which participants in the distribution chain may infer the contents of a case, pallet, or other aggregate of individual units, packages, or containers of dangerous drugs, from a unique identifier associated with the case, pallet, or other aggregate, without opening each case, pallet, or other aggregate or otherwise individually validating each unit.

(c) Manufacturers, wholesalers, and pharmacies opting to employ the use of inference as authorized by the board to comply with the pedigree requirements shall document their processes and procedures in their standard operating procedures (SOPs) and shall make those SOPs available for board review.

(d) SOPs regarding inference shall include a process for statistically sampling the accuracy of information sent with inbound product.

(e) Liability associated with accuracy of product information and pedigree using inference shall be specified in the board s regulations.

(Added by Stats. 2008, Ch. 713, Sec. 11. Effective January 1, 2009.)