Department of Consumer Affairs Board of Pharmacy

California E-Pedigree Law

California’s e-pedigree requirements for prescription drugs will take effect on a staggered basis from January 1, 2015 through July 1, 2017. Changes enacted by SB 1307 (Ridley-Thomas, Chapter 713, Statutes of 2008) instituted the following schedule.

The implementation compliance dates are:

  • 50 percent of a manufacturer’s products by 2015;
  • The remaining 50 percent of the manufacturer’s products by 2016;
  • Wholesalers and repackagers must accept and forward products with the e-pedigree by July 1, 2016; and
  • Pharmacy and pharmacy warehouses must accept and pass e-pedigrees by July 1, 2017.

Read more in the February 2009 issue of The Script on page 6.

 

4034.  (a) "Pedigree" means a record, in electronic form, containing information regarding each transaction resulting in a change of ownership of a given dangerous drug, from sale by a manufacturer, through acquisition and sale by one or more wholesalers, manufacturers, or pharmacies, until final sale to a pharmacy or other person furnishing, administering, or dispensing the dangerous drug. The pedigree shall be created and maintained in an interoperable electronic system, ensuring compatibility throughout all stages of distribution.
  (b) A pedigree shall include all of the following information:
  (1) The source of the dangerous drug, including the name, the federal manufacturer's registration number or a state license number as determined by the board, and principal address of the source.
   (2) The trade or generic name of the drug, the quantity of the dangerous drug, its dosage form and strength, the date of the transaction, the sales invoice number, the container size, the number of containers, the expiration dates, and the lot numbers.
   (3) The business name, address, and the federal manufacturer's registration number or a state license number as determined by the board, of each owner of the dangerous drug, and the dangerous drug shipping information, including the name and address of each person certifying delivery or receipt of the dangerous drug.
   (4) A certification under penalty of perjury from a responsible party of the source of the dangerous drug that the information contained in the pedigree is true and accurate.
   (c) A single pedigree shall include every change of ownership of a given dangerous drug from its initial manufacture through to its final transaction to a pharmacy or other person for furnishing, administering, or dispensing the drug, regardless of repackaging or assignment of another National Drug Code (NDC) Directory number.
   (d) A pedigree shall track each dangerous drug at the smallest package or immediate container distributed by the manufacturer, received and distributed by the wholesaler, and received by the pharmacy or another person furnishing, administering, or dispensing the dangerous drug.
   (e) Any return of a dangerous drug to a wholesaler or manufacturer shall be documented on the same pedigree as the transaction that resulted in the receipt of the drug by the party returning it.
   (f) If a licensed health care service plan, hospital organization, and one or more physician organizations have exclusive contractual relationships to provide health care services, drugs distributed between these persons shall be deemed not to have changed ownership.
   (g) The following transactions are not required to be recorded on a pedigree:
   (1) The provision of samples of dangerous drugs by a manufacturer' s employee to an authorized prescriber, provided the samples are dispensed to a patient of the prescriber without charge.
   (2) An injectable dangerous drug that is delivered by the manufacturer directly to an authorized prescriber or other entity
directly responsible for administration of the injectable dangerous drug, only for an injectable dangerous drug that by law may only be administered under the professional supervision of the prescriber or other entity directly responsible for administration of the drug. Injectable dangerous drugs exempted from the pedigree requirement by this paragraph may not be dispensed to a patient or a patient's agent for self-administration, and shall only be administered to the patient, as defined in Section 4016, by the prescriber or other authorized entity that received the drug directly from the manufacturer.
   (3) The exemption in paragraph (2) shall expire and be inoperative on January 1, 2010, unless prior to that date the board receives, at a public hearing, evidence that entities involved in the distribution of the injectable dangerous drugs subject to that paragraph are not able to provide a pedigree in compliance with all of the provisions of California law, and the board votes to extend the expiration date for the exemption until January 1, 2011. The decision as to whether to extend the expiration date shall be within the sole discretion of the board, and shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of the Government Code.
   (h) If a manufacturer, wholesaler, or pharmacy has reasonable cause to believe that a dangerous drug in, or having been in, its possession is counterfeit or the subject of a fraudulent transaction, the manufacturer, wholesaler, or pharmacy shall notify the board within 72 hours of obtaining that knowledge. This subdivision shall apply to any dangerous drug that has been sold or distributed in or through this state.
   (i) "Interoperable electronic system" as used in this chapter means an electronic track and trace system for dangerous drugs that uses a unique identification number, established at the point of manufacture, contained within a standardized nonproprietary data format and architecture, that is uniformly used by manufacturers, wholesalers, and pharmacies for the pedigree of a dangerous drug.
   (j) The application of the pedigree requirement in pharmacies shall be subject to review during the board's sunset review to be conducted as described in subdivision (f) of Section 4001.
   (k) This section shall become operative on January 1, 2009. However, the board may extend the date for compliance with this section and Section 4163 until January 1, 2011, in accordance with Section 4163.5.

4126.5.  (a) A pharmacy may furnish dangerous drugs only to the following:
   (1) A wholesaler owned or under common control by the wholesaler from whom the dangerous drug was acquired.
   (2) The pharmaceutical manufacturer from whom the dangerous drug was acquired.
   (3) A licensed wholesaler acting as a reverse distributor.
   (4) Another pharmacy or wholesaler to alleviate a temporary shortage of a dangerous drug that could result in the denial of health care.  A pharmacy furnishing dangerous drugs pursuant to this paragraph may only furnish a quantity sufficient to alleviate the temporary shortage.
   (5) A patient or to another pharmacy pursuant to a prescription or as otherwise authorized by law.
   (6) A health care provider that is not a pharmacy but that is authorized to purchase dangerous drugs.
   (7) To another pharmacy under common control.
   (b) Notwithstanding any other provision of law, a violation of this section by either a pharmacy whose primary or sole business is filling prescriptions for patients of long-term care facilities or a person engaged in a prohibited transaction with a pharmacy whose primary or sole business is filling prescriptions for patients of long-term care facilities may subject the persons who committed the violation to a fine not to exceed the amount specified in Section 125.9 for each occurrence pursuant to a citation issued by the board.
   (c) Amounts due from any person under this section on or after January 1, 2005, shall be offset as provided under Section 12419.5 of the Government Code.  Amounts received by the board under this section shall be deposited into the Pharmacy Board Contingent Fund.
   (d) For purposes of this section, "common control" means the power to direct or cause the direction of the management and policies of another person whether by ownership, by voting rights, by contract, or by other means.
   (e) For purposes of subdivision (b) of this section and subdivision (s) of Section 4301, "long-term care facility" shall have the same meaning given the term in Section 1418 of the Health and Safety Code.


4163. (a) A manufacturer or wholesaler may not furnish a dangerous drug or dangerous device to an unauthorized person.
  (b) Dangerous drugs or dangerous devices shall be acquired from a person authorized by law to possess or furnish dangerous drugs or dangerous devices. When the person acquiring the dangerous drugs or dangerous devices is a wholesaler, the obligation of the wholesaler shall be limited to obtaining confirmation of licensure of those sources from whom it has not previously acquired dangerous drugs or dangerous devices.
  (c) Except as otherwise provided in Section 4163.5, commencing on January 1, 2009, a wholesaler or pharmacy may not sell, trade, or transfer a dangerous drug at wholesale without providing a pedigree.
  (d) Except as otherwise provided in Section 4163.5, commencing on January 1, 2009, a wholesaler or pharmacy may not acquire a dangerous drug without receiving a pedigree.

4163.1.  It is the intent of the Legislature that commencing on January 1, 2007, and continuing through the full implementation of the pedigree requirements specified by Section 4163, manufacturers and wholesalers shall use best efforts to provide in the most readily accessible form possible, information regarding the manufacturer's specific relationships in the distribution of dangerous drugs with wholesalers.


4163.5.  The board may extend the date for compliance with the requirement for a pedigree set forth in Sections 4034 and 4163 until January 1, 2011, if it determines that manufacturers or wholesalers require additional time to implement electronic technologies to track the distribution of dangerous drugs within the state. A determination by the board to extend the deadline for providing pedigrees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.

4169.  (a) A person or entity may not do any of the following:
   (1) Purchase, trade, sell, or transfer dangerous drugs or dangerous devices at wholesale with a person or entity that is not licensed with the board as a wholesaler or pharmacy.
   (2) Purchase, trade, sell, or transfer dangerous drugs that the person knew or reasonably should have known were adulterated, as set forth in Article 2 (commencing with Section 111250) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.
   (3) Purchase, trade, sell, or transfer dangerous drugs that the person knew or reasonably should have known were misbranded, as defined in Section 111335 of the Health and Safety Code.
   (4) Purchase, trade, sell, or transfer dangerous drugs or dangerous devices after the beyond use date on the label.
   (5) Fail to maintain records of the acquisition or disposition of dangerous drugs or dangerous devices for at least three years.
  (b) Notwithstanding any other provision of law, a violation of this section or of subdivision (c) or (d) of Section 4163 may subject the person or entity that has committed the violation to a fine not to exceed the amount specified in Section 125.9 for each occurrence, pursuant to a citation issued by the board.
  (c) Amounts due from any person under this section shall be offset as provided under Section 12419.5 of the Government Code.  Amounts received by the board under this section shall be deposited into the Pharmacy Board Contingent Fund.
  (d) This section shall not apply to a pharmaceutical manufacturer licensed by the Food and Drug Administration or by the State Department of Health Services.
  (e) This section shall become operative on January 1, 2007.

4084. (a) When a board inspector finds, or has probable cause to believe, that any dangerous drug or dangerous device is adulterated, misbranded, or counterfeit, the board inspector shall affix a tag or
other marking to that dangerous drug or dangerous device. The board inspector shall give notice to the person that the dangerous drug or dangerous device bearing the tag or marking has been embargoed.
  (b) When a board inspector has found that an embargoed dangerous drug or dangerous device is not adulterated, misbranded, or counterfeit, a board inspector shall remove the tag or other marking.
  (c) A board inspector may secure a sample or specimen of a dangerous drug or dangerous device. If the board inspector obtains a sample prior to leaving the premises, the board inspector shall leave
a receipt describing the sample.
  (d) For the purposes of this article, "counterfeit" shall have the meaning defined in Section 109905 of the Health and Safety Code.
  (e) For the purposes of this article, "adulterated" shall have the meaning defined in Article 2 (commencing with Section 111250) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.
  (f) For the purposes of this article, "misbranded" shall have the meaning defined in Article 3 (commencing with Section 111330) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.

4085.  (a) It is unlawful for any person to remove, sell, or dispose of an embargoed dangerous drug or dangerous device without permission of the board.
   (b) When a board inspector has reasonable cause to believe, that the embargo will be violated, a board inspector may remove the embargoed dangerous drug or dangerous device from the premises.

4086.  (a) If a dangerous drug or dangerous device is alleged to be adulterated or counterfeit, the board shall commence proceedings in the superior court in whose jurisdiction the dangerous drug or dangerous device is located, for condemnation of the dangerous drug or dangerous device.
   (b) If the court finds that an embargoed dangerous drug or dangerous device is adulterated or counterfeit, the dangerous drug or dangerous device shall, after entry of the judgment, be destroyed at the expense of the claimant or owner, under the supervision of the board.  All court costs and fees and all reasonable costs incurred by the board in investigating and prosecuting the action, including, but not limited to, the costs of storage and testing, shall be paid by the claimant or owner of the dangerous drug or dangerous device.
   (c) A superior court of this state may condemn any dangerous drug or dangerous device pursuant to this article.  In the absence of an order, the dangerous drug or dangerous device may be destroyed under the supervision of the board who has the written consent of the owner, his or her attorney, or authorized representative.  If the board cannot ascertain ownership of the dangerous drug or dangerous device within 30 days of establishing an embargo, the board may destroy the dangerous drug or dangerous device.