Health Care Department Operations Manual

Cancel

Chapter 3 – Health Care Operations

Article 5 – Pharmacy and Medication Services

View All Sections >

3.5.16 Medication Inventory Management, Labeling, and Storage

  • Policy

    • California Department of Corrections and Rehabilitation (CDCR) and California Correctional Health Care Services (CCHCS) shall manage, label, package, and store medications in compliance with applicable federal and state laws and regulations. Unusable medications shall not be stocked.

  • Operational Roles

    • The Chief Support Executive (CSE) shall:

      • Ensure the availability and proper maintenance (including, but not limited to, temperature monitoring) of medication storage areas and equipment in accordance with manufacturer recommendations and policy in all health care service areas.

      • Provide digital data logger (DDL) updates and alarm summaries to the institution Resource Management Subcommittee.

    • The Pharmacist-in-Charge (PIC) shall be responsible for:

      • The management of medication inventory within the pharmacy and automated drug delivery system (ADDS).

      • The work completed by licensed pharmacy staff, assisting with medication inventory control and appropriate inventory storage in licensed non-pharmacy storage areas, e.g., licensed correctional clinic (LCC), Correctional Treatment Center (CTC), or Skilled Nursing Facility.

      • Fulfilling the role of Primary Vaccine Coordinator for the institution and managing vaccine inventory.

      • The dispensing or furnishing of medications in compliance with applicable federal and state laws and regulations inclusive of product labeling and patient prescription labeling.

      • Processing of shipments to the state-contracted reverse distributor.

      • Monthly inspections of medication storage areas.

    • The Chief Nurse Executive (CNE) shall be responsible for the management, accountability, administration, and issuance of medications in LCCs or other nursing patient-care areas.

    • The Supervising Dentist (SD) shall be responsible for the management, accountability, administration, and issuance of medications in dental LCCs.

    • The Chief Executive Officer (CEO), CSE, PIC, CNE, and SD shall collaborate to correct identified medication management deficiencies within their respective health care service areas.

  • Local Operating Procedure Requirements

    • Each institution shall be required to maintain a local operating procedure (LOP) for temperature excursions which shall be reviewed annually by the Warden and CEO. The LOP shall include, but is not limited to:

    • Listing the institution personnel that shall be included in automated notifications to include, but not be limited to:

      • PIC and pharmacy staff for data, signal, and battery alarms.

      • CNE, Supervising Registered Nurse (SRN) III (if applicable), and SRN II for data alarms.

      • Warden-designated Plant Operations staff for data alarms.

      • Information technology (IT) staff for signal alarms.

      • Dental representative.

    • Defining the location specific actions required by staff classification for the three types of alarms (data, signal, and battery) and the three types of DDL probes (ambient [room], refrigerator, and freezer).

    • Defining the role of Plant Operations in addressing the cause of the data alarm (e.g., refrigerator repair needed, air conditioner repair needed), the role of the institution’s IT in addressing connection issues with the DDL (e.g., missing certificate, issue with Wi-Fi parameters, Wi-Fi signal strength unable to support connectivity), and the role of the CSE, or designee, in addressing a battery replacement schedule and equipment replacement when a DDL fails to operate properly.

    • Listing all licensed medication storage locations and secure alternate storage locations identified for use during temperature excursions.

      • Controlled Room Temperature:

        • For licensed clinic locations, whenever an ambient DDL alarms, nursing staff shall move the medication carts to the LOP-designated secure alternate storage location.

        • For those storage locations utilizing an ADDS, a sign shall be placed on the equipment which states “Do not use.”  Medications shall be pulled from an alternate location until this sign has been removed by pharmacy staff.

      • Refrigerator or Freezer:

        • Whenever a refrigerator or freezer DDL alarms, medications stored within them shall be relocated to the nearest operating refrigerator or freezer. A sign shall be placed on the refrigerator or freezer indicating the alternative location where medications are being stored.

  • Procedure

    • General Labeling Requirements

      • Prescription labels shall comply with the requirements in applicable federal and state laws, including California Code of Regulations (CCR), Title 16, Section 1707.5 and Business and Professions Code, Sections 4076, 4076.5 and 4076.6.

        • Chemical symbols shall not be used.

        • Latin abbreviations shall not be used on Keep-on-Person (KOP) labels.

      • Patient-specific labels shall include the information listed below:

        • Name and address of the pharmacy dispensing the medication.

        • The date the prescription/order was issued (e.g., order transmission issue date).

        • The name of the patient (including the CDCR number).

        • The name of the provider.

        • Clear directions for use of the medication.

        • The name and the strength or dosage of the medication dispensed.

        • Liquid dosage forms shall include concentration as well as dosage.

        • The quantity of the medication dispensed.

        • The medication expiration date, not to exceed the pharmaceutical manufacturer’s expiration date in accordance with Section (d)(6), Beyond-Use Dates.

        • Administration type (e.g., KOP, NA, DOT, PAROLE).

        • Auxiliary labels as needed (e.g., precautionary labels).

        • Prescription number.

        • Pharmaceutical manufacturer.

        • Physical description of the product (e.g., tablet, capsule).

        • The patient’s housing and bed location.

        • The condition or purpose for which the medication was prescribed if the condition or purpose is indicated on the prescription/order.

      • Non-legend (over-the-counter [OTC]) medications shall be labeled in conformance with federal and state laws, such as consumer-ready packaging, and do not require a prescription label from the pharmacy unless ordered as a prescription by a provider and dispensed by the pharmacy.

      • Only persons licensed to dispense medications may apply or modify a prescription label.  Persons licensed to dispense include, but are not limited to:

        • Providers authorized within the scope of their practice.

        • Pharmacists.

        • Registered Nurses working in an LCC pursuant to California Business and Professions Code, Division 2, Chapter 6, Article 2, Scope of Regulation, Section 2725.1.

      • It shall be the responsibility of the authorized prescriber to identify patients that require labeling or counseling in a language other than English and to identify the language required.

      • Where usable medications have been returned to stock, the pharmacy shall ensure any confidential patient information has been completely removed before a new label is placed.

    • General Packaging Requirements

      • Medication Packaging

        • Medication containers must be provided that are consistent with CDCR Department Operations Manual, Section 54030.1, which specifies types of materials incarcerated persons may possess.  Medication containers that are acceptable for use when dispensing/furnishing medications include, but are not limited to:

        • Amber pharmacy vials with snap-on lids.

        • Plastic zip lock bags (amber or clear) with medications in unit-dose packaging.

        • Unit-of-use drug cards (blister pack and bubble pack).

        • Unit-dose.

        • Medication vials with child-proof packaging dispensed to patients for family visits, the Community Prisoner Mother Program, or release.

      • Central Fill Packaging

        • When feasible and if the medication is available through the Central Fill Pharmacy, filling should be processed through the Central Fill Pharmacy’s automated, high-volume dispensing equipment to ensure efficiency and to reduce waste.

        • Solid oral dosage forms provided by Central Fill Pharmacy shall be packaged in either blister cards containing quantities in increments of 30 or in unit-dose packaging.  

      • Patient-Specific Medication Quantity Excluding Release Medications

        • The pharmacy shall dispense medication in the quantity necessary to complete prescriptions/orders except as noted below:

        • Routinely administered medications limited to a 30-day supply per dispense.  Exceptions may be permitted as determined by the Systemwide Medication Management Subcommittee.

        • Unit-of-use medications in multiples of package size may be dispensed utilizing the nearest manufacturer package size subject to the pharmacist’s judgment.

        • PRN (as needed) medications shall be dispensed in multiples of 30 tablets or capsules (for oral dosage forms) whenever feasible and shall not exceed a 30-day supply per dispense.

        • Prescriptions/orders for patients housed in CTCs or other inpatient areas, or in temporary locations may be dispensed in quantities less than a 30-day supply.

        • During downtime procedures, when prescriptions/orders are recorded on a CDC 7221, automatic stop prescriptions/orders apply to licensed inpatient beds only in accordance with the Health Care Department Operations Manual (HCDOM), Section 3.5.14, Additional Requirements Pertaining to Licensed Inpatient Facilities.

    • Storage Requirements and Inventory Management

      • General Requirements

        • Medications shall not be left exposed to the environment (i.e., out of containers or in containers with lids left off overnight) or left unsecured.

        • Breaches of security or losses shall be handled pursuant to the HCDOM, Section 3.5.26, Break-In, Theft/Loss from Pharmacy or Medication Storage Areas.

        • Containers shall be clean, intact, and closed securely.

        • Medication for internal use in liquid, tablet, capsule, or powder form shall be stored separately from medication for external use.

        • Test agents, germicides, disinfectants, and other household substances shall be stored separately from medication.

        • Each patient’s medications shall remain in the original package and with the labeling originally received from the pharmacy until the time of administration.

        • Non-patient-specific medication (i.e., floor stock), excluding OTC medication in consumer-ready packaging used for registered nurse standardized procedures, shall only be maintained in licensed units (e.g., CTCs, SNFs, Hospices, and LCCs).

        • All look-alike/sound-alike medications, high-alert medications, and hazardous medications shall be properly identified and stored.

        • No outdated medications shall be stored with usable medications.

        • Every effort shall be made to keep the quantity and variety of medications maintained in inventory at a level to ensure appropriate availability but also to prevent waste and unsafe storage conditions.

        • The Electronic Health Record System (EHRS) shall be used to order floor stock from a correctional pharmacy.  When EHRS is unavailable, all floor stock medications and supplies shall be ordered from the correctional pharmacy on a CDCR 7244, Drug Order.

        • Storing or consuming food and drink, chewing gum or tobacco, and applying cosmetics are prohibited in areas where medications are prepared or administered.

        • Food, drink, and laboratory specimens shall not be stored in the medication refrigerator/freezer.

      • Unusable Medications

        • Medications approaching manufacturer expiration date or designated beyond-use date (BUD) shall be removed from inventory no sooner than 30 days prior to the medication expiration date or BUD.

        • Medications that no longer meet federal and state requirements, including those that have reached their expiration date or BUD, shall be immediately removed from active inventory.   Staff removing the medication from active inventory shall remove any confidential patient information from the packaging. 

        • Unusable medications shall be handled as follows:

          • Drug Enforcement Administration (DEA) controlled substances waste shall be witnessed and documented and limited to contaminated and partial doses only. Complete doses dispensed from a CCHCS pharmacy and no longer necessary shall be returned to the pharmacy for appropriate return to stock. Patient-specific complete doses dispensed from a contracted pharmacy shall be wasted and documented at the clinic location. Expired medications shall be returned to the pharmacy for reverse distribution as defined in the HCDOM, Section 3.5.9, DEA Schedule II-V Controlled Substances.

          • Medications that have become outdated within the pharmacy shall be quarantined and disposed of as waste or shipped to the state-contracted reverse distributor pursuant to Section (d)(7) below.  Medications that have become outdated within a health care location shall be disposed of pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

          • All medications that are not DEA controlled substances and are unusable shall be placed in the appropriate disposal container pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

          • Health care staff receiving medications returned by patients shall remove confidential patient information and immediately place in the appropriate disposal container pursuant to the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff. Refer to the Pharmaceutical Waste vs. Pharmacy Returns process map for guidance.

        • Medications dispensed in error including, but not limited to, the following reasons, shall be returned to the pharmacy:

          • The medication container has been filled with the wrong medication, dose, or quantity.

          • The container has been mislabeled (e.g., wrong administration method).

          • The medication is a duplicate order or issue.

        • Medications that are overstocked or considered of a quantity not needed for use in the health care setting shall be handled as follows:

          • DEA controlled substances dispensed from a CCHCS pharmacy shall be returned to the pharmacy for inspection, destruction, or redistribution as appropriate.

          • All other prescription or OTC medication may be returned to the pharmacy for redistribution or moved from one LCC to another LCC within the same institution pursuant to Business and Professions Code, Section 4187.

          • Health care staff shall make every effort to minimize the loss of medications due to outdating by attempting to locate other health care settings that may utilize this medication prior to becoming outdated.

          • Every medication storage area shall have a return bin for returning medications to the pharmacy.  Where a storage area has a medication refrigerator or freezer, there shall be a separate return bin for the refrigerator, the freezer, and room temperature medications.  Each return bin shall be clearly labeled “Pharmacy returns only; medication waste prohibited.”

      • Temperature Requirements

        • Medications shall be stored at controlled room temperature as follows:

          • Controlled room temperature is between 20°C and 25°C (68°-77°F); excursions permitted between 15° and 30° C (59°–86°F) with transient spikes up to 40° C permitted (refer to United States Pharmacopeia [USP] 1079.2 Controlled Room Temperature).

        • Medications that require refrigerated or frozen storage shall be stored as follows:

          • Refrigeration temperature shall be maintained between 2°C and 8°C (36°-46°F).

          • Freezer temperature shall be maintained between -50°C and -15°C (-58°-5°F).

        • The medication manufacturer recommendation for storage temperature shall be adhered to when different from above.

      • Temperature Monitoring Equipment

        • All licensed medication storage locations shall have a CCHCS-approved DDL to monitor room, refrigerator, and freezer temperatures, as appropriate.

        • DDL settings are established statewide via the Systemwide Medication Management Subcommittee and maintained by Central Pharmacy Services.

        • The CSE, or designee, shall:

          • Maintain a current list of all DDLs, refrigerators, and freezers which shall include, but is not limited to:

            • Make, model, media access control ID, serial number, and property tag number for DDLs, refrigerators and freezers.

            • Location of equipment to include yard, building, and room.

            • Anticipated replacement date.

            • Maintenance schedule for all DDLs, refrigerators, freezers.

            • Schedule for DDL probe and battery replacement.

          • Maintain a process for replacement of malfunctioning DDLs or alternative placement of visual thermometers and DDL batteries during each shift.

          • Maintain a process for installation of new equipment.

          • Coordinate with health care, Plant Operations, and IT with corrective actions, adjustments, repairs or replacements following recorded excursions.

        • DDLs shall not be powered off except as outlined in process maps as part of the deactivation process or following the removal of medications from a licensed area.

      • Temperature Monitoring

        • Pharmacy staff shall conduct a daily audit of the DDL temperature report for all licensed medication storage locations during regular pharmacy business hours. When a data excursion is identified, it shall be referred to a pharmacist on duty for further action.

        • A CDCR 7217, Medication Storage Temperature Log, shall only be posted and used in the event of a DDL malfunction and sent to pharmacy when DDL function has been restored.  During DDL malfunction:

          • Thermometers shall be monitored during hours of operation by licensed health care staff working in the area where the thermometer and the medications are located. The thermometer shall be checked as soon as the area begins daily operation. The temperature excursion process shall be followed if any out-of-range temperatures are shown to have occurred with manual notifications replacing DDL automated notifications. Temperature recordings are required at least:

            • Room temperatures: once daily.

            • Refrigerator and freezer temperatures: twice daily.

          • If the area or pharmacy is closed for the day, the CDCR 7217 shall indicate the area as being “closed.”

          • Each temperature log either completed or replaced by a functioning DDL shall remain in a designated location for pharmacy staff to retrieve. Once reviewed, pharmacy staff shall store the temperature logs in a file for the designated location. The pharmacy shall maintain the files for completed logs for a period of three years.

      • Temperature Excursions

        • When there is a DDL audible alarm, automated notifications shall be sent, and action is required by the staff working in that area to avoid loss of medication viability.

          • For refrigerator and freezer alarms, medications shall be moved to an alternate storage location immediately.

          • For room temperature alarms, medications shall be moved to a secure alternate storage location within four hours of the occurrence of the alarm (either audible or automated notification).  Prompt action preserves the usable life of the medication.

        • Alternate storage locations shall be secure and limit access to medication to licensed health care staff only.

        • Audible alarms may be silenced by pharmacy or supervisory nursing staff once medications have been relocated.  Refer to the Data Logger Tip Sheet for a description of how to silence an audible alarm.

        • On the next pharmacy regular business day following a temperature excursion data alarm, the PIC, or designee, shall determine whether the LOP was utilized to preserve the medication.  If the LOP was utilized or in the judgement of the PIC, or designee, the LOP should have been utilized, the remaining medication impacted by the excursion shall be located and evaluated.  The PIC, or designee, shall:

          • Examine the medication for visual integrity to include, but not be limited to, appearance, packaging, and product coloration.

          • Use professional judgement to determine the impact of the excursion on the viability of the medication.  Refer to the Data Logger Pharmacist Guide to determine viability.

          • Quarantine, inventory, and determine cost of any medication which is categorized as unusable following the performance of Sections (d)(3)(F)1.a. and (d)(3)(F)4.b. above.

            • Refer to the HCDOM, Section 5.1.4, Reporting of Actual or Suspected Incidents of Fraud, Errors and Improper Governmental Activities, for the report which shall be completed and to which the inventory should be attached.

            • This completed document shall be retained by the PIC with a copy sent to the CEO, Regional Pharmacy Services Manager, and the Statewide Chief of Pharmacy Services.

            • Excursions resulting in unusable medication shall be reported to the institution Medication Management Subcommittee in the month following the occurrence of the excursion.

          • The PIC, or designee, shall clear the data alarm and record at minimum the following information:

            • Time and date of excursion.

            • Duration of the excursion.

            • Highest temperature or lowest temperature reached during the excursion.

            • Whether the medications were relocated pursuant to the institution LOP.

            • When evaluation of the medication by a pharmacist was completed.

            • Whether medication was determined to be unusable.

            • Whether the cause of the excursion was corrected.

          • In the event that the root cause for the excursion has not been corrected, the alarm can be temporarily suspended.  Refer to Temporary Suspensions in the Data Logger Pharmacist Guide to resolve excursions.  When the suspension is performed properly, the data alarm will permit entry of notes for each suspension entered.

          • When all medications have been addressed and temperatures returned to USP standards, pharmacy staff shall restore the functionality of the audible alarm.

        • Vaccine Storage and Handling Post-Excursion

          • Immediately move vaccines to an alternate functional storage location and quarantine in a separate container in the refrigerator or freezer with a “do not use vaccines” notice until pharmacy staff can retrieve or manufacturer guidance can be obtained, if:

          • The refrigerator temperature is warmer than 8°C (46°F)

          • The freezer temperature is warmer than -15°C (5°F).

    • Pharmacy Security

      • Possession of a key or electronic access to the pharmacy where dangerous drugs and DEA controlled substances are stored shall be restricted to a pharmacist.  Access to one additional pharmacy key for emergency purposes shall be maintained in a tamper evident manner pursuant to CCR, Title 16, Section 1714(e).

      • Each pharmacist, while on duty, shall be responsible for the security of the pharmacy including provisions for effective control against theft or diversion of medications.

      • A pharmacist shall be responsible for any individual who enters the pharmacy for the purposes of performing clerical, inventory control, housekeeping, delivery, maintenance, or similar functions relating to the pharmacy. The pharmacist shall remain present in the pharmacy during all times the authorized individual is present.  Temporary absences of the pharmacist are only permitted in accordance with the HCDOM, Section 3.5.27, Temporary Absence of the Pharmacist.

      • Institution locksmiths shall not access pharmacy locations without the presence and direct supervision of a pharmacist.

    • Non-Pharmacy Medication Area Security

      • The CEO and CNE, or designee, shall ensure that medications stored in the nursing units, LCCs, or other nursing patient care areas are properly secured.  The CEO and SD, or designee, shall ensure that medications stored in the dental clinics are properly secured.

      • Doors to medication areas shall remain locked.

      • Medications shall be stored in locked rooms, cabinets, drawers, or carts of sufficient size in an orderly manner to prevent crowding.  Locked mobile medication storage (e.g., carts) shall be secured in a locked room when unattended.

      • Keys to the medication rooms, cabinets, drawers, or carts shall be restricted to licensed nursing, dental, and pharmacy staff who shall be personally accountable for them.

      • Keys shall not be left in drawers, hung on walls, given to patients, or given to non-medical personnel.

      • Institution locksmiths shall not access medication storage areas without the presence and direct supervision of health care staff.

      • Each institution shall establish a process for the transfer of keys (medication cabinets, drawers, carts, or medication rooms) among licensed nursing, dental, and pharmacy staff that precludes involvement of non-health care personnel.

      • Non-patient-specific DEA controlled substances shall be securely stored in an ADDS and must be under double lock in the medication areas at all times until withdrawn for administration.  The CNE shall be responsible for ensuring limited access, key control, and medication accountability for all DEA controlled substances.

      • Patient-specific DEA controlled substances (e.g., release medications or long-acting buprenorphine injectable) shall be stored under double lock.

      • Any unlicensed individuals in the medication area (e.g., housekeeping staff, patients being treated) shall be under the direct observation of licensed nursing, dental, or pharmacy staff.

      • Pharmacists shall conduct monthly inspections of medication storage areas in collaboration with licensed nursing or dental staff. A report of identified deficiencies shall be provided to the CEO and the CNE, SD, or Health Program Manager III as applicable.

    • Beyond-Use Dates

      • Medications supplied in the manufacturer’s original packaging and stored appropriately shall be usable until the expiration date (considered to be midnight of the last day of the month indicated, unless otherwise stated) on the package unless otherwise stated in the Storage and Handling section of the Prescribing Information or the CCHCS Guideline for Calculating Beyond-Use Date.

        • Any medication whose beyond-use date varies from the manufacturer’s expiration date shall be handled as follows:

          • A BUD label shall be affixed.

          • Pharmacy shall communicate the BUD to the appropriate staff.

          • The health care staff member that initially opens the container shall calculate the BUD to confirm it matches the date provided by pharmacy.  This date and the staff’s initials shall be written on the medication label or container.  No medication shall be used once it has reached the BUD.

      • Repackaged and dispensed medications shall comply with the Food and Drug Administration requirements and USP guidelines for determining BUDs.

        • For non-sterile solid and liquid dosage forms that have been repackaged into single-unit and unit-dose containers, the BUD shall be one year or less unless stability data or the manufacturer’s labeling indicates otherwise.

        • For all other types of non-sterile dosage forms, the BUD is one year or the time remaining of the expiration date, whichever date arrives first unless otherwise stated in the CCHCS Guideline for Calculating Beyond-Use Date.

      • Single-Dose and Multi-Dose Vials

        • All single-dose injectables are considered expired after the first puncture and shall be discarded after their first opening, including sterile water for injection, regardless of remaining solution.

        • All DEA controlled substances in multi-dose vials shall have a written BUD of 28 days (or sooner if the manufacturer specifies differently) once opened or needle-punctured.  The remainder of the vial shall either be wasted or, if on the U.S. Food and Drug Administration Drug Shortages list, returned to the ADDS for continued use and tracking.

        • All prescription medications in multi-dose vials which are not DEA controlled substances shall have a written BUD of 28 days (or sooner if the manufacturer specifies differently) once opened or needle-punctured and shall be stored according to manufacturer guidance within the licensed medication storage location for future administration.

    • Use of Contracted Vendors by Pharmacy for the Return of Medications

      • The PIC, or designee, shall supervise the disposition of outdated, discontinued, or overstocked medications within the pharmacy.

      • The pharmacy shall store outdated medications separate from active medication stock until disposition. The outdated medication storage area shall be clearly labeled.

      • The pharmacy shall return to the vendor any usable product for which credit can be obtained.  For those items that credit cannot be obtained, the pharmacy shall utilize contracted vendors for:

        • Reverse distribution: DEA controlled and non-DEA controlled substances shall be submitted to the reverse distributor for potential credit by the manufacturers.

        • Medical waste destruction: Any medication not eligible for vendor credit or reverse distribution shall be destroyed by the contracted medical waste hauler in accordance with the HCDOM, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff.

      • The pharmacy shall retain records of return, credit, and certificates of destruction documents for a period of three years.

    • Medication Recalls

      • Recalled medications in licensed units (including, but not limited to, CTC, LCC, and ADDS) shall be returned to the pharmacy for disposition.

      • The pharmacy shall ensure that the recalled medication is unavailable for use and is either sent back to the manufacturer or destroyed per the recommendation of the manufacturer.

      • When a medication is recalled by the manufacturer, the PIC shall determine whether the recall has been extended to the pharmacy level or to the patient level.

        • Pharmacy Level:

          • If the recall is limited to the pharmacy level, the PIC, or designee, shall inspect all pharmacy and all patient care areas, including ADDS.  Medications affected by the recall shall be returned to the pharmacy for disposition.

          • The pharmacy shall maintain a record of pharmacy-level recalls.  This record shall be kept for a period of three years from the date of the recall.

        • Patient Level:

          • If the recall extends to the patient level, the PIC shall identify all patients who may be in possession of the recalled medication(s).

          • The PIC shall notify the CME, the CNE, prescriber, and nursing staff in patient care areas where medication may have been administered or distributed to patients.

          • Most medications stored in an ADDS were dispensed dose-by-dose and would have already been fully consumed.  For affected unit-of-use medications, the PIC shall notify the CME, the CNE, prescriber, and nursing staff in patient care areas where medication may have been administered or distributed to patients.

          • The pharmacy shall coordinate with Nursing for retrieval and replacement of all medications affected by the recall.

          • The pharmacy shall maintain a record of patient-level recalls including a list of potentially affected patients and disposition.  This record shall be kept for a period of three years from the date of the recall.

  • References

    • California Business and Professions Code, Division 2, Chapter 6, Article 2, Section 2725.1

    • California Business and Professions Code, Division 2, Chapter 9, Article 3, Section 4064.5

    • California Business and Professions Code, Division 2, Chapter 9, Article 4, Sections 4076, 4076.5, and 4076.6

    • California Business and Professions Code, Division 2, Chapter 9, Article 7, Section 4119.5, Transfer or Repackaging Dangerous Drugs by Pharmacy

    • California Business and Professions Code, Division 2, Chapter 9, Article 13.5, Sections 4187-4187.5

    • California Code of Regulations, Title 16, Division 17, Article 2, Section 1707.5. Patient-Centered Labels for Prescription Drug Containers; Requirements

    • California Code of Regulations, Title 16, Division 17, Article 2, Section 1714(e)

    • California Code of Regulations, Title 22, Division 5, Chapter 1, Article 3, Section 70263. Pharmaceutical Service General Requirements

    • Department Operations Manual, Chapter 5, Article 43, Section 54030.1, Inmate Property

    • Health Care Department Operations Manual, Chapter 3, Article 2, Section 3.2.1, Disposal of Regulated Waste Generated by Health Care Staff

    • Health Care Department Operations Manual, Chapter 3, Article 5, Section 3.5.9, DEA Schedule II-V Controlled Substances

    • Health Care Department Operations Manual, Chapter 3, Article 5, Section 3.5.14, Additional Requirements Pertaining to Licensed Inpatient Facilities

    • Health Care Department Operations Manual, Chapter 3, Article 5, Section 3.5.26, Break-In, Theft/Loss from Pharmacy or Medication Storage Areas

    • Health Care Department Operations Manual, Chapter 3, Article 5, Section 3.5.27, Temporary Absence of the Pharmacist

    • Health Care Department Operations Manual, Chapter 5, Article 1, Section 5.1.4, Reporting of Actual or Suspected Incidents of Fraud, Errors, and Improper Governmental Activities

    • Food and Drug Administration Drug Quality Assurance – Drug Repackagers and Drug Relabelers https://www.fda.gov/media/75182/download

    • United States Pharmacopeia, USP 32, General Notices and Requirements

    • United States Pharmacopeia, USP 797, Pharmaceutical Compounding – Sterile Preparations

  • Policy Control
    Executive Sponsor: Deputy Director, Medical Services
    Effective: 02/2008
    Revision: 05/27/2026