Article 5 – Pharmacy and Medication Services
3.5.15 Procuring, Receiving, and Stocking of Medications
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Procedure Overview
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The pharmacy shall be responsible for procuring, compounding (if authorized), receiving, dispensing, distributing, and storing pharmaceuticals used for treatment of patients in the institution.
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Purpose
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To ensure a standardized method of procuring medications.
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Procedure
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Medication Procuring and Receiving from Pharmaceutical Wholesalers or Manufacturers
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All medications shall be ordered from the Central Fill Pharmacy, pharmaceutical prime vendor, or other state-contracted vendors when available. Exceptions to this policy must be pre-approved by the Chief of Pharmacy Services. All vendors shall be licensed with the California State Board of Pharmacy.
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If medications are unavailable from the Central Fill Pharmacy or the pharmaceutical prime vendor, they may be purchased from another state-contracted vendor in accordance with applicable California Correctional Health Care Services procurement processes. In this case, the Pharmacist-in-Charge (PIC) shall obtain a drug pedigree for medications ordered in accordance with federal and state regulations.
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The PIC, or designee, shall maintain adequate stock of medications as follows:
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By transmitting the order to the Central Fill Pharmacy, pharmaceutical prime vendor, or other state-contracted vendor.
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Documenting ordered quantities.
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Ensuring pharmacy staff inventories items received against the invoices upon order arrival and immediately resolves any discrepancies (e.g. missing or incorrect items).
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Ensuring pharmacy staff notify the Food and Drug Administration using Form FDA 3911 and other trading partners within 24 hours if medication received was an illegitimate product or respond to a request for information within two business days in the event of a recall or to investigate a suspected or illegitimate product.
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All medications shall be received by a pharmacist or other methods (e.g., the warehouse handles over-the-counter medications) acceptable by federal and state regulations.
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A process shall be in place to ensure that responsible parties (e.g., analyst and support staff in other departments or institutions) mark goods received for timely payment to vendors.
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Drug Enforcement Administration (DEA) controlled stock shall be received pursuant to the Health Care Department Operations Manual, Section 3.5.9, DEA Schedule II-V Controlled Substances.
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Medications Received from Contracted Pharmacies
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Pedigrees for drugs dispensed patient-specific by CCHCS-contracted pharmacies are the responsibility of the dispensing pharmacy and need not be maintained at the CCHCS pharmacy location.
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Maintenance of Records
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All invoices must be stored and maintained in accordance with federal and state regulations for three years.
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Pharmaceutical Supply & Inventory Control
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The PIC, or designee, shall be responsible for the establishment and maintenance of a system for monitoring medication stock used in the facility.
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A pharmacy inventory shall be performed annually in the last quarter of the fiscal year.
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The inventory may be performed by the pharmaceutical prime vendor in accordance with the pharmaceutical prime vendor contract.
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The annual inventory report shall be provided to the institution Medication Management Committee and the Chief of Pharmacy Services.
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Inventories of controlled substances shall be performed pursuant to the Health Care Department Operations Manual, Section 3.5.9, DEA Schedule II-V Controlled Substances and the DEA Controlled Substances Accountability Training Manual.
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Use of Incarcerated Person Labor
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Incarcerated persons shall not be allowed to handle or move any dangerous drugs as defined by Business and Professions Code, Division 2, Chapter 9, Article 2, Section 4022, or participate in any aspect of the pharmacy operation.
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References
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United States Code, Title 21, Chapter 9, Subchapter I, Section 301 et. seq.
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California Business and Professions Code, Division 2, Chapter 9, Article 2, Section 4022
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Business & Professions Code, Division 2, Chapter 9, Section 4059.5
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Business & Professions Code, Division 2, Chapter 9, Section 4081
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Food and Drug Administration, DSCSA Implementation: Product Tracing Requirements for Dispenses – Compliance Policy (Revised), https://www.fda.gov/media/92650/download
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Health Care Department Operations Manual, Chapter 3, Article 5, Section 3.5.9, DEA Schedule II-V Controlled Substances
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DEA Controlled Substances Accountability Training Manual
https://cdcr.sharepoint.com/sites/cchcs_lifeline_pharmacy/SiteAssets/SitePages/Best-Practices/Pharmacy-Services-Controlled-Substances-Accountability-Manual.pdf
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Revision History
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Effective: 04/2008
Revised: 12/2/2024
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