California CodesBusiness and Professions Code - BPCDivision 2 — Healing ArtsChapter 9 — PharmacyArticle 25 — Automated Drug Delivery SystemSection 4427.7

(a) A pharmacy holding an ADDS license shall complete a self-assessment, performed pursuant to Section 1715 of Title 16 of the California Code of Regulations, evaluating the pharmacy’s compliance with pharmacy law relating to the use of the ADDS. All information regarding operation, maintenance, compliance, error, omissions, or complaints pertaining to the ADDS shall be included in the self-assessment.

(b) The pharmacy shall comply with all recordkeeping and quality assurance requirements established in pharmacy law and regulation, and shall maintain those records within the licensed pharmacy holding the ADDS license and separate from other pharmacy records.

Notes

Requires a pharmacy holding an ADDS license to complete the specified self-assessment covering legal compliance and all information on ADDS operation, maintenance, compliance, errors, omissions, and complaints. It must also meet pharmacy-law recordkeeping and quality-assurance requirements and keep those records within the licensed pharmacy holding the ADDS license, separate from other pharmacy records.

Use as reference

Lexinter.net | California Code, Business and Professions Code - BPC § 4427.7 | https://laws.lexinter.net/codes/california/business-and-professions-code/division-2/chapter-9/article-25/section-4427-7

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