Information Bulletin

PAs SIGNING FOR DRUG SAMPLES
PHARMACY LAW
BUSINESS AND PROFESSIONS CODE

This document is provided for informational purposes only. For further clarification of these laws please contact the California Board of Pharmacy at at (916) 574-7900.

4022. Dangerous Drug - Dangerous Device Defined
"Dangerous drug" or "dangerous device" means any drug or device unsafe for self-use, except veterinary drugs that are labeled as such, and includes the following:
(a) Any drug that bears the legend: "Caution: federal law prohibits dispensing without prescription, Rx only" or words of similar import.
(b) Any device that bears the statement: "Caution: federal law restricts this device to sale by or on the order of a ______, Rx only", or words of similar import, the blank to be filled in with the designation of the practitioner licensed to use or order use of the device.
(c) Any other drug or device that by federal or state law can be lawfully dispensed only on prescription or furnished pursuant to Section 4006.

4023. Device
"Device" means any instrument, apparatus, machine, implant, in vitro reagent, or contrivance, including its components, parts, products, or the byproducts of a device, and accessories that are used or intended for either of the following:
(a) Use in the diagnosis, cure, mitigation, treatment, or prevention of disease in a human or any other animal.
(b) To affect the structure or any function of the body of a human or any other animal. For purposes of this chapter, "device" does not include contact lenses, or any prosthetic or orthopedic device that does not require a prescription.

4060. Controlled Substance - Prescription Required; Exceptions

No person shall possess any controlled substance, except that furnished to a person upon the prescription of a physician, dentist, podiatrist, or veterinarian, or furnished pursuant to a drug order issued by a certified nurse-midwife pursuant to Section 2746.51, a nurse practitioner pursuant to Section 2836.1, or a physician assistant pursuant to Section 3502.1. This section shall not apply to the possession of any controlled substance by a manufacturer, wholesaler, pharmacy, physician, podiatrist, dentist, veterinarian, certified nurse-midwife, nurse practitioner, or physician assistant, when in stock in containers correctly labeled with the name and address of the supplier or producer.

Nothing in this section authorizes a certified nurse-midwife, a nurse practitioner, or a physician assistant to order his or her own stock of dangerous drugs and devices.

4061. Distribution of Drug as Sample; Written Request Required
(a) No manufacturer's sales representative shall distribute any dangerous drug or dangerous device as a complimentary sample without the written request of a physician, dentist, podiatrist, or veterinarian. However, a certified nurse-midwife who functions pursuant to a standardized procedure or protocol described in Section 2746.51, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, or a physician assistant who functions pursuant to a protocol described in Section 3502.1, may sign for the request and receipt of complimentary samples of a dangerous drug or dangerous device that has been identified in the standardized procedure, protocol, or practice agreement. Standardized procedures, protocols, and practice agreements shall include specific approval by a physician. A review process, consistent with the requirements of Section 2725 or 3502.1, of the complimentary samples requested and received by a nurse practitioner, certified nurse-midwife, or physician assistant shall be defined within the standardized procedure, protocol, or practice agreement.
(b) Each written request shall contain the names and addresses of the supplier and the requester, the name and quantity of the specific dangerous drug desired, the name of the certified nurse-midwife, nurse practitioner, or physician assistant, if applicable, receiving the samples pursuant to this section, the date of receipt, and the name and quantity of the dangerous drugs or dangerous devices provided. These records shall be preserved by the supplier with the records required by Section 4059.
(c) Nothing in this section is intended to expand the scope of practice of a certified nurse-midwife, nurse practitioner, or physician assistant.