2011 California Code
Business and Professions Code
DIVISION 2. HEALING ARTS [500 - 4999.122]
ARTICLE 11. Wholesalers and Manufacturers
Section 4163.2

(a) (1) A manufacturer, wholesaler, or pharmacy lawfully possessing or owning dangerous drugs manufactured or distributed prior to the operative date of the pedigree requirements, specified in Sections 4034 and 4163, may designate these dangerous drugs as not subject to the pedigree requirements by preparing a written declaration made under penalty of perjury that lists those dangerous drugs.

(2) The written declaration shall include the National Drug Code Directory lot number for each dangerous drug designated. The written declaration shall be submitted to and received by the board no later than 30 days after the operative date of the pedigree requirements. The entity or person submitting the written declaration shall also retain for a period of three years and make available for inspection by the board a copy of each written declaration submitted.

(3) The board may, by regulation, further specify the requirements and procedures for the creation and submission of these written declarations. Information contained in these declarations shall be considered trade secrets and kept confidential by the board.

(b) Any dangerous drugs designated on a written declaration timely created and submitted to the board may be purchased, sold, acquired, returned, or otherwise transferred without meeting the pedigree requirements, if the transfer complies with the other requirements of this chapter.

(Added by Stats. 2008, Ch. 713, Sec. 10. Effective January 1, 2009. Conditionally inoperative as prescribed in subd. (a) of Section 4034.1.)