California CodesBusiness and Professions Code - BPCDivision 2 — Healing ArtsChapter 9 — PharmacyArticle 3 — Scope of Practice and ExemptionsSection 4061

(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, optometrist, veterinarian, nurse practitioner practicing pursuant to Section 2837.103 or 2837.104, or naturopathic doctor pursuant to Section 3640.7. 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, a physician assistant who functions pursuant to a protocol described in Section 3502.1, or a naturopathic doctor who functions pursuant to a standardized procedure or protocol described in Section 3640.5, 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, 3502.1, or 3640.5, of the complimentary samples requested and received by a nurse practitioner practicing pursuant to Section 2836.1, certified nurse-midwife, physician assistant, or naturopathic doctor, 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, physician assistant, or naturopathic doctor, 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, physician assistant, or naturopathic doctor.

Notes

Prohibits manufacturer sales representatives from distributing complimentary dangerous-drug or device samples without a written request from an authorized prescriber. Specified nurse-midwives, nurse practitioners, physician assistants, and naturopathic doctors may request and receive approved samples under physician-approved procedures or protocols; written requests must identify supplier, requester, product, quantity, recipient, and receipt date, and the rule does not expand scope of practice.

Use as reference

Lexinter.net | California Code, Business and Professions Code - BPC § 4061 | https://laws.lexinter.net/codes/california/business-and-professions-code/division-2/chapter-9/article-3/section-4061

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