Use this SOP to control, secure, prepare, administer, document, and dispose of medications and medication-related supplies safely. Besa Health keeps only approved emergency medications onsite. All other prescriptions are sent electronically or otherwise transmitted to the patient’s preferred pharmacy.

📚 Resources Needed

  • Current approved emergency medication inventory

  • Locked MA Room and locked medication storage

  • Medication expiration and disposal log

  • Emergency medication administration record and the patient’s medical record

  • Sharps containers, biohazardous waste containers, and hazardous-waste tracking documents

  • Temperature-monitoring equipment for any medication that requires controlled storage

  • Current manufacturer package inserts and storage instructions

⚠ Clinic Scope

  • Only approved emergency medications are maintained or provided onsite.

  • Besa Health does not routinely dispense take-home medications, drug samples, over-the-counter medications, therapeutic formula, vaccines, or controlled substances.

  • All patient prescriptions are sent to the patient’s preferred pharmacy. Staff must confirm and document the preferred pharmacy before transmitting a prescription.

  • Besa Health does not operate an onsite pharmacy.

  • Requirements in this SOP that address controlled substances, routine dispensing, samples, vaccines, or an onsite pharmacy are conditional safeguards. They must be implemented before any such service or product is introduced.

✅ Before You Start

  • Confirm the medication appears on the approved emergency medication inventory and has not expired.

  • Confirm the order, patient, medication, dose, route, frequency, amount, allergies, and authorized administrator.

  • Check the original container, manufacturer’s label, lot number, expiration date, storage condition, and container integrity.

  • Do not use any medication that is expired, contaminated, adulterated, improperly labeled, improperly stored, or of questionable sterility.

  • Keep the patient under continuous staff observation during an emergency. Never leave a patient or customer alone during an emergency.

🚀 Tips & Tricks

  • Use the earliest-expiring medication first when all other clinical factors are equal.

  • Keep emergency medications in their original containers and off the floor.

  • Complete the monthly inventory and expiration review at the same time each month.

  • Quarantine questionable medication immediately and label it clearly so it cannot be used.

📘 Instructions

Step 1: Confirm Scope And Route Prescriptions

  • Only approved emergency medications may be stored or administered onsite. Do not create an onsite supply of routine patient medications.

  • Send every non-emergency patient prescription to the patient’s preferred pharmacy. Confirm the pharmacy name and location with the patient and document the selected pharmacy in the medical record.

  • Do not provide take-home stock, drug samples, over-the-counter medication, infant formula, therapeutic formula, vaccines, or controlled substances under the current clinic scope.

  • Do not sell, charge, or bill a Medi-Cal member for drugs or sample medications, consistent with California Business and Professions Code, Article 13, section 4193.

Step 2: Secure Emergency Medications And Supplies

  • Store all emergency medications in the locked MA Room, which is restricted to authorized staff. Maintain this secured storage in accordance with California Business and Professions Code section 4172.

  • Store prescription products, over-the-counter products if ever approved, drug samples if ever approved, hypodermic needles and syringes, medical sharps, and prescription pads in a lockable cabinet or room within the clinic.

  • Treat the term all drugs as including samples and over-the-counter drugs, consistent with the Medical Board interpretation reflected in 22 CCR sections 75032 and 75033.

  • Keep medication storage secured at all times unless there is no access by unauthorized persons and authorized clinic personnel remain in the immediate area.

  • Provide keys or access credentials only to staff authorized by the physician, consistent with 16 CCR, Chapter 2, Division 13, section 1356.3. At all other times, lock medications, medication supplies, and hazardous substances.

  • Controlled substances, if ever introduced, must remain locked at all times.

Step 3: Maintain Inventory Access And Distribution Records

  • Maintain a current list of every emergency medication and formula approved for clinic use. Include the expiration date and disposal method for each item. If Besa ever provides drug or formula distribution services, this written SOP governs the safe and effective distribution, control, storage, use, and disposition of those products.

  • Complete and retain a monthly medication expiration and inventory review.

  • When an emergency medication is administered, document the patient’s name, medication name, dose, route, frequency, amount given, date and time, lot number, manufacturer, expiration date, ordering provider, and authorized person who administered or dispensed it.

  • If the clinic ever distributes a drug or formula, maintain a patient distribution log containing the patient’s name, drug or formula name, lot number, manufacturer, quantity distributed, expiration date, and prescriber or dispenser. If medication samples are ever approved, label each sample or write prescribing information directly on the package, maintain a sample log, and document the medication name and strength, instructions for use, and quantity or duration of therapy in the patient’s chart.

  • Enter every drug or formula dispensed or administered in the patient’s medical record.

Step 4: Prepare Medications Safely

  • Draw up medication only in a designated clean medication-preparation area that is not adjacent to a sink, water source, or another potential source of contamination.

  • Clean and disinfect the medication-preparation area regularly and whenever contamination occurs.

  • Do not prepare multidose vials in an exam room, treatment room, procedure room, or other patient-care area.

  • Follow the manufacturer’s package insert and the applicable medication-administration SOP.

Step 5: Store Medications Under Required Conditions

  • Store medications separately from food, laboratory specimens, human specimens, cleaning supplies, and any item that may cause contamination.

  • If a vaccine storage unit ever must contain other medications or sealed laboratory or human specimens, place those items in sealed containers on separate shelves below the vaccines.

  • Separate medications by route of administration, especially ophthalmic and otic products and internal and external preparations.

  • Maintain the temperature, humidity, and light conditions required to preserve each product’s identity, strength, quality, and purity.

  • Do not allow room temperature in a medication-storage area to exceed 30°C or 86°F.

  • Keep medications off the floor and in their original containers with the manufacturer’s label preserved.

  • A drug or device is adulterated if it contains a filthy, putrid, or decomposed substance or was prepared, packed, or held under unsanitary conditions. Treat any product held under conditions that may introduce filth or make it injurious to health as contaminated.

Step 6: Administer And Document Emergency Medications

  • Only a physician or other licensed professional lawfully authorized to dispense medication, including an NP, CNM, RN, or PA acting on the order of a physician or surgeon, may dispense medication.

  • Medical assistants, office managers, and receptionists do not dispense drugs.

  • Medical assistants may perform only the medication-administration tasks allowed by law, their documented training, a specific written or standing order, and the separate Medication Administration By Medical Assistant SOP.

  • Document every administered medication in the patient’s medical record, including the medication name, dose, route, frequency, amount given, date, time, and clinical response.

  • Continue emergency response and observation. Do not leave the patient alone.

Step 7: Check Expiration Dates And Dispose Of Medication

  • The manufacturer’s expiration date must appear on every drug and formula label. Treat any prescription drug without an expiration date as expired.

  • When a drug requires reconstitution at dispensing, its label must state expiration information for both the reconstituted and unreconstituted product.

  • Check all medications, including emergency medications and any future vaccine, sample, infant formula, or therapeutic formula, for expiration at least monthly.

  • Do not distribute, dispense, or administer an expired medication.

  • Return outdated medication to the manufacturer for disposal or place it in the approved biohazardous-waste stream for pickup by a registered hazardous-waste transporter, as applicable.

  • Do not dispose of outdated medication through a sink, toilet, drain, or other public waterway.

  • Unused medications are treated as toxic waste under 40 CFR Part 261 and must follow the clinic’s hazardous and medical waste procedure.

Step 8: Follow Multidose Vial And Prefilled Syringe Rules

  • Discard a medication vial whenever sterility is compromised or questionable.

  • Date any multidose vial when it is opened or first accessed. Discard it within 28 days unless the manufacturer specifies a shorter or longer period.

  • For a multidose vaccine that does not require reconstitution, remaining doses may be administered through the manufacturer’s printed expiration date unless the manufacturer states otherwise. The CalOptima protocol lists polio, meningococcal polysaccharide vaccine, PPSV, TIV, IPV, and yellow fever as examples.

  • Discard an entered TUBERSOL vial after 30 days in use. Never use it after expiration.

  • Do not routinely prefill syringes. Similar-looking vaccines or medications can lead to administration errors.

  • Discard an unused syringe that staff prefilled if it is not used on the same day.

  • Discard a manufacturer-prefilled syringe that has been activated by removing the cap or attaching a needle if it remains unused at the end of the clinic day.

  • If one vaccine type is being used in a special setting such as a community influenza clinic, no more than 10 syringes may be filled in advance. The same person who fills them must administer them as soon as possible.

Step 9: Follow Controlled Substance Standards If Scope Changes

  • Besa Health does not currently store or dispense controlled substances. Do not bring a controlled substance into clinic stock without written leadership approval, required registration, and implementation of every control below.

  • Store controlled substances separately from other drugs in a securely locked, substantially constructed cabinet in accordance with 21 CFR 1301.75.

  • Treat Schedule I, II, III, IV, and V substances listed in California Health and Safety Code sections 11053–11058 as controlled substances. The CalOptima protocol notes that they do not require double locking, but they must remain securely locked. Its PCP-office examples are Valium, testosterone, Belsomra, Viberzi, Lyrica, and DayVigo.

  • Limit authorized access to physicians, dentists, podiatrists, physician assistants, licensed nurses, and pharmacists, and to the absolute minimum number of specifically authorized employees.

  • When maintenance staff, nonemployee maintenance personnel, business guests, or visitors must enter or pass through a controlled-substance storage area, an employee specifically authorized in writing must adequately observe the area.

  • Maintain a dose-by-dose controlled-substance log containing the provider’s DEA number, medication name, original quantity, dose, date, patient name, authorized dispenser’s name, and number of doses remaining.

Step 10: Follow Vaccine Storage Standards If Scope Changes

  • Besa Health does not currently provide routine vaccines. Before vaccine services begin, approve a written Vaccine Management Plan covering routine and emergency management and implement the following requirements.

  • For Vaccines for Children providers, maintain a written plan to protect vaccines during a power outage or refrigerator or freezer malfunction. Identify an alternate doctor’s office, clinic, hospital, or pharmacy. Never store vaccines in a private residence.

  • Train staff to verbalize the response to an out-of-range temperature. Contacting the Vaccines for Children program or the manufacturer is an acceptable response step.

  • Refrigerate vaccines immediately upon receipt and follow each package insert.

  • A diluent does not require refrigeration when the vaccine will be administered immediately after the diluent is added.

  • Do not store vaccines in refrigerator or freezer doors, on floors, in vegetable bins, or under or near cooling vents, except as permitted for MMR and varicella-containing vaccines.

  • Keep refrigerated vaccines at 2–8°C or 36–46°F. Examples include DTaP, Td, Tdap, hepatitis A, hepatitis B, IPV, pneumococcal, rotavirus, Hib, inactivated influenza, FluMist, MCV, HPV, recombinant zoster, and combinations of these vaccines.

  • Store varicella and MMRV vaccines at –15°C or 5°F or colder and protect them from light. MMR may be refrigerated or frozen; the VFC recommendation cited by CalOptima is to store MMR in the freezer with MMRV. Never freeze vaccine diluents.

  • Use purpose-built refrigerator-only or freezer-only units, or standalone household units dedicated to biologics, for temporary and long-term storage.

  • Prevent accidental disconnection by applying Do Not Disconnect labels and by avoiding surge protectors with on/off switches.

  • Never use a dormitory-style or bar-style combined refrigerator and freezer to store vaccines.

  • Document refrigerator and freezer temperatures at least daily and twice daily for VFC providers.

  • Use a digital data logger with a buffered probe, active external display, continuous monitoring and recording, and calibration at least every two years.

  • Keep a backup monitoring device available for emergency transport and whenever the primary logger is being calibrated.

Step 11: Provide VIS And Use CAIR If Vaccine Scope Changes

  • Before administering a vaccine, present and offer the patient the most recent Vaccine Information Statement and offer a copy.

  • Document the date the VIS was provided or presented and offered, and document the VIS publication date. Follow the federal six-month transition allowance stated in the CalOptima protocol unless current law or CDC instructions require earlier use.

  • Obtain current VIS documents from state or local health departments, the CDC, or the Vaccines for Children program. The CalOptima protocol also lists the CDC Immunization Hotline at 800-232-2522.

  • Participate in the California Immunization Registry or the applicable local registry as required by CalOptima. Staff must be able to use the registry to access a member’s immunization record even when the clinic does not administer vaccines.

  • If Besa begins administering immunizations, report member-specific immunization information periodically to the registry established in the contractor’s service area as part of the Statewide Immunization Information System. Report after the member’s initial health assessment and after every other health-care visit in which an immunization is provided.

  • Complete reporting in accordance with all applicable state and federal laws.

Step 12: Follow Dispensing Labeling And Pharmacy Rules If Scope Changes

  • Besa Health does not operate an onsite pharmacy and does not routinely dispense patient medications. All patient prescriptions continue to go to the patient’s preferred pharmacy.

  • If dispensing is ever approved, comply with all state and federal laws and allow only lawfully authorized licensed personnel to dispense on a physician’s or surgeon’s order.

  • Preserve every label and keep medication in its original container.

  • Use only a clean, intact container with a secure closure.

  • Label any dispensed drug container with the provider’s name, patient’s name, drug name, dose, frequency, route, quantity dispensed, manufacturer’s name, and lot number.

  • A commercial controlled-substance container must display the symbol for its schedule.

  • If an onsite clinic-owned pharmacy is ever established, display the California State Board of Pharmacy license onsite. A licensed pharmacist must monitor drug distribution and medication-dispensing and storage procedures.

  • Any pharmacy dispensing controlled substances must be registered with the DEA and licensed by the California State Board of Pharmacy.

Step 13: Label Hazardous Substances And Track Disposal

  • Follow current Cal/OSHA safety practices and 29 CFR 1910.1030.

  • Do not remove the manufacturer’s label from a bag, bottle, box, can, cylinder, or other container while hazardous material or residue remains.

  • When biohazardous waste is prepared for offsite transport, use containers that comply with United States Department of Transportation requirements.

  • Require the registered medical-waste transporter to maintain a completed tracking document and provide a copy to Besa Health as the medical-waste generator.

  • Label every portable hazardous-chemical container and each secondary container used to transfer or prepare a hazardous substance with the substance identity, a hazard warning using words, pictures, or symbols, and the preparation or transfer date.

🛠 Troubleshooting

A Prescription Was Sent To The Wrong Pharmacy

  • Confirm the patient’s preferred pharmacy and whether the prescription was received or filled.

  • Notify the prescribing clinician and correct the prescription using the approved clinical workflow. Document the correction and patient communication.

An Emergency Medication Is Expired Damaged Or Questionable

  • Remove it from usable stock immediately, label it Do Not Use, and place it in the designated quarantine area.

  • Replace the item promptly and dispose of it through an approved manufacturer-return or hazardous-waste process.

Medication Storage Is Unlocked Or Accessed By An Unauthorized Person

  • Secure the area immediately, preserve relevant records, notify the supervising clinician or clinic leader, and reconcile the inventory.

  • Document the event and follow the applicable safety or incident-reporting procedure.

Storage Temperature Is Out Of Range

  • Do not use affected medication until the manufacturer or appropriate program confirms whether it remains usable.

  • Quarantine the product, record the temperature and duration, notify the clinic leader, and follow the emergency storage plan.

A Controlled Substance Vaccine Sample Or Routine Medication Arrives

  • Do not add it to clinic stock or administer or distribute it under the current Besa scope.

  • Secure it from unauthorized access, notify clinic leadership, and arrange lawful return, transfer, or disposal. Complete all required program controls before any future use.

✅ Completion Check

  • Only approved emergency medications are stored onsite in the locked MA Room.

  • Every patient prescription was sent to the patient’s documented preferred pharmacy.

  • The medication was verified, stored, prepared, administered, and documented correctly.

  • The monthly inventory and expiration check is current.

  • Expired, compromised, or unused medication was quarantined and disposed of through an approved method, never through public waterways.

  • Controlled-substance, vaccine, sample, routine-dispensing, and onsite-pharmacy services remain inactive unless all conditional requirements are implemented.

  • No patient or customer was left alone during an emergency.

References