Pharmacy Standards of Operation

PURPOSE: This rule defines terms used in the regulations of the State Board of Pharmacy and outlines the conditions necessary for the operation of a pharmacy. (1) Pharmacies must be safely operated at all times, in compliance with applicable state and federal law. Except as otherwise provided by law, pharmacies must also comply with the following: (A) Pharmacies shall not introduce or enforce any policies, procedures, systems, or practices that jeopardize, inhibit, or threaten patient safety or the safe provision of pharmacy services. A licensed pharmacist must be physically present within the confines of the dispensing area of a licensed pharmacy whenever any person other than a licensed pharmacist compounds, prepares, dispenses, or any way provides a drug, medicine, or poison pursuant to a lawful prescription or medication order. The pharmacist must be able to render immediate assistance and able to identify and correct any errors before the drug, medicine, or poison is dispensed or sold. A sign advising the public that no pharmacist is on duty must be manually or electronically posted when no pharmacist is on duty at the pharmacy. The signs must be prominently displayed on all entrance doors and the prescription counter of the pharmacy. Sign lettering must be at least two inches (2”) in height; (B) Except as otherwise provided by law, a pharmacist shall personally inspect and verify the accuracy of the final contents of any prescription or medication order and the affixed label prior to dispensing; (C) Adequate staffing and resources must be provided to allow licensees/registrants to safely and accurately provide pharmacy services. Pharmacies must be equipped with properly functioning pharmaceutical equipment for the pharmacy services performed as recognized by the latest edition of the United States Pharmacopoeia (USP) or Remington’s Pharmaceutical Sciences; (D) References/resources must be physically maintained or immediately accessible in electronic form at the pharmacy that include the following: 1. A current print or electronic edition of statutes and rules governing the pharmacy’s practice, including, but not limited to, Chapters 338 and 195, RSMo, 20 CSR 2220 and, if applicable, 19 CSR 30 governing controlled substances; 2. Generally recognized reference(s) or other peer-reviewed resource(s) that include the following items/topics: A. All drugs approved by the United States Federal Drug Administration (FDA) as appropriate to the practice site; B. Pharmacology of drugs; C. Dosages and clinical effects of drugs; and D. Patient information and counseling; (E) All Missouri and federal pharmacy licenses, permits, or registrations must be current and accurate, including the pharmacy’s name, permit classification(s), and address; (F) Individuals practicing or assisting in the practice of pharmacy must be appropriately licensed or registered with the board and appropriately trained and competent to perform assigned duties. Any person other than a pharmacist or permit holder who has independent access to legend drug stock on a routine basis in a pharmacy must be registered or licensed with the board as a pharmacy technician or intern pharmacist. Except as otherwise authorized by law, nonresident pharmacists providing pharmacy services for patients or pharmacies located in Missouri must hold a Missouri pharmacist license or must be working for a Missouri licensed pharmacy; (G) Pharmacy facilities and equipment must be maintained in a clean and sanitary condition at all times and trash must be disposed of in a timely manner. 1. Appropriate sewage disposal and a hot and cold water supply within the pharmacy must be available. The required water supply may not be located in a bathroom. 2. Waste and hazardous materials must be handled and disposed of in compliance with applicable state and federal law. 3. The pharmacy must be free from insects, vermin, and animals of any kind. Animals are not allowed in pharmacies, except for service animals as defined by the Americans with AND INSURANCE Disabilities Act (ADA); (H) Adequate security and locking mechanisms must be maintained to prevent unauthorized access to the pharmacy and to ensure the safety and integrity of drugs and confidential records. Pharmacy traffic must be restricted to authorized persons so that proper control over drugs and confidential records can be maintained at all times. Pharmacies dispensing or stocking controlled substances must comply with all federal and state controlled substance security requirements; (I) Medication and drug-related devices must be properly and accurately prepared, packaged, dispensed, distributed, and labeled under clean, and when required, aseptic conditions. Staff must wear disposable gloves when physically touching individual dosage units. Pharmacies shall not fill or refill any prescription or medication order after one (1) year from the date issued by the prescriber; (J) Offsite storage. Pharmacies may maintain storage sites or warehouse facilities for the storage of pharmaceuticals or required/confidential pharmacy records at a separate address or premises from the main pharmacy, provided the storage facility is registered with the board. To register, the pharmacy must submit the following to the board in writing: the storage facility’s address, hours of operation (if applicable), and the pharmacy permit numbers of the pharmacies that utilize the facility. No registration fee is required. 1. Adequate security and storage conditions must be maintained at these facilities to guarantee the security and integrity of records, medication, and drug-related devices. At a minimum, storage facilities must maintain a functioning alarm system. Any breach in security must be documented and reported to the board electronically or in writing within fifteen (15) days of the breach. 2. Medication stored at an offsite storage facility pursuant to this subsection may only be used by a pharmacy for the sole purpose of distributing drugs solely within its own pharmacy operations. A drug distributor license is required if an offsite storage facility is used to store/distribute medication for multiple pharmacies, regardless of pharmacy ownership. 3. No record less than two (2) years old may be stored offsite. Patient records stored at an offsite facility must be retrievable within two (2) business days of a request from the board or its authorized designee. 4. Storage and warehouse locations will be considered facilities of a pharmacy pursuant to section 338.240, RSMo, and will be subject to inspection by the board pursuant to section 338.150, RSMo; (K) If the pharmacy is located in a facility that is accessible to the public and the pharmacy’s hours of operation are different from those of the remainder of the facility, ceilings and walls must be constructed of a substantial material so that the pharmacy permit area is separate and distinct from the remainder of the facility. Drop down ceilings or other openings that would allow unauthorized access into the pharmacy are not allowed; (L) Licensee/Registrant Identification and Signage. 1. All board licensees and registrants must wear an identification badge or similar identifying article that identifies their name and title when practicing or assisting in the practice of pharmacy (e.g., pharmacist, pharmacy technician, intern pharmacist). 2. The licenses/registrations for all pharmacists, technicians, and intern pharmacists regularly working in the pharmacy must be maintained in a central location on the premises of the pharmacy. Individual licenses/registrations must have a photo attached that is not smaller than two by two inches (2” x 2”). The required licenses/registrations must be immediately retrievable during an inspection or available to the public if requested. Licensees or registrants regularly working for more than one (1) pharmacy, temporarily working as a relief pharmacist outside of their regular pharmacy work location, or practicing pharmacy at a non-pharmacy location must have proper identification of their pharmacy license in their possession while practicing or assisting in the practice pharmacy (e.g., wallet card, current online verification). 3. A sign must be physically or electronically posted at the pharmacy indicating that the pharmacy is licensed and regulated by the Missouri Board of Pharmacy along with the board’s current address, telephone number, and primary email address. The board will provide the required sign at no cost. Alternatively, licensees may post an electronic copy of the required sign, provided the size and type of the electronic sign and lettering equals or exceeds the board issued sign and the electronic sign is constantly visible by the public during the pharmacy’s normal business hours. The required sign must be prominently posted in close proximity to the pharmacy in a manner and location that is easily viewable and readable by the public; (M) All board licensed pharmacies must be under the supervision of a pharmacist-in-charge designated with the board who holds a current and active Missouri pharmacist license. The pharmacist-in-charge must be actively engaged in pharmacy activities at the pharmacy and must be physically present at the pharmacy for a sufficient amount of time as needed to effectively supervise pharmacy activities and ensure pharmacy compliance. For pharmacies located outside of Missouri, the designated pharmacist-in-charge must hold a current and active pharmacist license in the state where the pharmacy is located. 1. In the event the pharmacist-in-charge designated with the board changes, the pharmacy may not continue operations until a new pharmacist-in-charge is named, except as otherwise authorized by this rule. A change of pharmacist-in-charge application must be submitted to the board with the applicable fee within fifteen (15) calendar days after a new pharmacist-incharge is designated. A controlled substance inventory must be taken at or immediately prior to a pharmacist-in-charge change as required by 20 CSR 2220-2.090. 2. If a new pharmacist-in-charge cannot be immediately designated after a pharmacist-in-charge change despite reasonable diligence, the pharmacy may appoint an interim supervising pharmacist for a period not to exceed thirty (30) days. The interim supervising pharmacist must meet the requirements of this rule and file a statement on a form approved by the board agreeing to be responsible for pharmacy compliance while serving as the interim supervising pharmacist. A documented controlled substance inventory must be taken when the interim supervising pharmacist is designated. Written notification of the interim supervising pharmacist designation must be immediately provided to the board at the board’s electronic mail address or via facsimile on a form approved by the board along with the required interim supervising pharmacist form; and (N) Licensees and registrants must maintain a current mailing address on file with the board. Licensees/registrants must notify the board electronically or in writing of any change in their mailing or employment address, within fifteen (15) days following the change; (O) When a pharmacy permit holder knows or should have known, within the usual and customary standards of conduct governing the operation of a pharmacy as defined in Chapter 338, RSMo, that an employee, licensed or unlicensed, has violated the pharmacy laws or rules, the permit holder shall be subject to discipline under Chapter 338, RSMo. (2) Drug Storage. Drugs must be properly stored and maintained in a thermostatically controlled area within temperature and humidity requirements as provided in the Food and Drug Administration approved drug product labeling or the United States Pharmacopeia (USP). (A) Temperatures in drug storage areas must be recorded and reviewed at least once each day the pharmacy is in operation. Alternatively, a continuous temperature monitoring system may be used if the system maintains ongoing documentation of temperature recordings that alerts a pharmacist when temperatures are outside of the required range and provides the amount of variance. (B) No outdated, misbranded, or adulterated drugs or devices may be dispensed, distributed, or maintained within the pharmacy’s active inventory, including prescription and related nonprescription items. Outdated, misbranded, or adulterated medication and medication for personal employee use must be quarantined in an area that is clearly identified and physically separate from medication maintained for dispensing, distribution, or other pharmacy use. Drugs for the personal use of pharmacy staff or personnel must be labeled in accordance with section 338.059, RSMo, or as otherwise required by law. (C) Food and beverage items that are not in their original, sealed manufacturer packaging must be stored separately from medication and medication-related devices. Open food or beverages used in compounding or intended for patient use with medication may be stored in the same area as drugs and drug-related devices, provided the items must be separated from other inventory and sanitary conditions are maintained at all times. (D) Appropriate lighting, ventilation, and humidity must be maintained in areas where drugs are stored and dispensed. Medication may not be stored on the floor. (E) Drug samples shall not be maintained in or dispensed by pharmacies, except as otherwise authorized by state and federal law, including, but not limited to, 21 U.S.C. section 353 and the federal Prescription Drug Marketing Act of 1987. (3) Record Keeping. Pharmacy records must be accurately maintained in compliance with applicable state and federal law. Records required by Chapters 195 and 338, RSMo, or divisions 20 CSR 2220 and 19 CSR 30 shall be available for inspection, photographing, or duplication by a board representative. (A) Pharmacies must maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of legend drugs. Each pharmacy shall designate either a primary manual or electronic record keeping system which will be used to record the dispensing of all prescriptions and medication orders. Poison sales may be recorded in a separate manual log. Except as otherwise authorized or required by law, at least three (3) separate files of prescriptions/ medication orders must be maintained: 1. A separate file for Schedule I and II controlled substances; 2. A separate file for Schedules III, IV, and V controlled substances; and 3. A separate file(s) for all other prescriptions/medication orders. (B) Distribution records. Unless otherwise authorized by law or the board, pharmacies shall maintain inventories and records of all legend drugs received and distributed that include: 1. The date of the transaction/distribution; 2. Product name, strength, and quantity; 3. The names of the parties; 4. The sender’s address or, for drugs distributed by the pharmacy, the receiver’s address; and 5. Any other information required by state or federal law. (C) Unless otherwise provided by law, records required by Chapter 338 or 20 CSR 2220 that do not have a specified retention time must be kept for two (2) years and readily retrievable at the request of the board or the board’s authorized designee. Records maintained at a pharmacy must be produced immediately or within two (2) hours of a request from the board or the board’s authorized designee, or by making a computer terminal available to the inspector for immediate use to review the records requested. Records not maintained at a pharmacy must be produced within three (3) business days of a board request. (4) Mandatory Reporting. Licensees, registrants, and permit holders must notify the board of any adverse action by another licensing state, jurisdiction, or government agency against the licensee/registrants/permit holder as required by section 338.075, RSMo, within fifteen (15) days of such action. Additionally, pharmacies must notify the board within fifteen (15) days of any final disciplinary action taken against a pharmacist, intern pharmacist, or pharmacy technician for conduct that might have led to disciplinary action under section 338.055, RSMo, or resignation of a licensee/registrant in lieu of such final disciplinary action. The notification must be provided in writing or electronically and include: (A) The pharmacy’s name and permit number; (B) Name and contact information for person making the notification; (C) The licensee’s or registrant’s name and license/registration number; (D) Date of action; and (E) Reason for action. (5) A home health or hospice agency licensed or certified according to Chapter 197, RSMo, or any licensed nurses of such agency, may possess drugs in the usual course of business of such agency without being licensed as a pharmacist or a pharmacy. (A) The following legend drugs/devices may be possessed by a home health or hospice agency identified in this section without a pharmacy license or permit: 1. Injectable dosage forms of sodium chloride and water; 2. Irrigation dosage forms of sodium chloride and water that carry a federal prescription only restriction; 3. Injectable dosage forms of heparin and alteplase in concentrations that are indicated for maintenance of venous access devices; 4. Injectable dosage forms of diphenhydramine and epinephrine; 5. Vaccines indicated for public health needs; and 6. Tuberculin test material. (B) The agency shall have policies and procedures that address— 1. Specific drugs authorized to be possessed by the agency and the nurse; 2. Indications for use of the drugs possessed; 3. Receiving orders from an authorized prescriber for drug administration; 4. Leaving drugs with the patient for routine care AND INSURANCE procedures; 5. Conditions for storing and transporting of the drugs by the agency and the nurse; and 6. Quantity of drugs possessed by the agency and the nurse. (C) The nurse must have authorization from an authorized prescriber, such as an individual patient order, protocol or standing order, to administer the drugs. (D) Up to a two- (2-) week supply of sodium chloride, water, and heparin may be left with the patient provided the patient or the patient’s representative has been instructed verbally or in writing on how to perform the procedure. Drugs left with the patient shall be labeled with instructions for use. A record shall be made of all drugs left with the patient in the patient’s medical record. Drugs left with the patient may not be returned to the agency. (E) Drugs may be stored at the agency or transported by the nurse, and shall be stored or transported at all times in accordance with the manufacturer’s storage requirements. Except as otherwise authorized by subsection (2)(C) of this rule, refrigerator units used by the agency for storing drugs shall not be used for storing non-drug items. (F) All drugs must be received from a licensed pharmacy or drug distributor. The quantity of drugs possessed by an agency shall be limited to that necessary to meet the needs of the agency’s patient population for two (2) weeks. (6) In addition to the other requirements of this rule, a Class I pharmacy within a residence must be located in a physically separate room that has a door with a suitable lock. Patients are not allowed in a Class I pharmacy located within a residence. Class I pharmacies may be inspected by the board as authorized by law, including Class I pharmacies located in a residence. The permit holder must arrange for a designated representative to be present for inspection, if requested by the board. Other than a Class I pharmacy, no pharmacy permit will be issued to a location that is located in a residence regardless of zoning. (7) Except as otherwise authorized by law, a licensee, permittee, or registrant of the board must cooperate with any investigation or inspection conducted by or on the board’s behalf. Cooperation includes responding fully and promptly to questions, providing copies of records as requested, executing releases for records as requested, allowing photographs or digital image capture of any facility licensed or permitted by the board, and appearing at interviews, hearings, or meetings scheduled by the board or the board’s authorized designee. (8) Exemptions. At its discretion, the board may grant an exemption to the facility requirements of this rule for a time period designated by the board if such exemption is not contrary to law and the exemption will provide equal or greater protection of the public safety, health, or welfare. Exemption requests must be submitted in writing and identify the specific exemption requested, the grounds for exemption, the requested exemption length, and proposed procedures or safeguards for protecting the public safety, health, or welfare if the exemption is approved. AUTHORITY: sections 338.240 and 338.280, RSMo 2016, and sections 338.010, 338.140, and 338.210, RSMo Supp. 2021.* This rule originally filed as 4 CSR 220-2.010. Original rule filed July 18, 1962, effective July 28, 1962. Amended: Filed Nov. 9, 1966, effective Nov. 19, 1966. Amended: Filed Oct. 27, 1970, effective Nov. 6, 1970. Amended: Filed Dec. 31, 1975, effective Jan. 10, 1976. Amended: Filed May 21, 1979, effective Nov. 12, 1979. Amended: Filed April 14, 1982, effective July 11, 1982. Amended: Filed April 16, 1985, effective Sept. 27, 1985. Amended: Filed Nov. 4, 1985, effective March 13, 1986. Amended: Filed Dec. 15, 1987, effective April 28, 1988. Amended: Filed Oct. 12, 1988, effective March 11, 1989. Amended: Filed Jan. 30, 1991, effective July 8, 1991. Amended: Filed Jan. 27, 1995, effective Sept. 30, 1995. Amended: Filed June 29, 1999, effective Jan. 30, 2000. Amended: Filed March 15, 2000, effective Sept. 30, 2000. Amended: Filed July 24, 2001, effective Feb. 28, 2002. Amended: Filed Feb. 18, 2003, effective Sept. 30, 2003. Amended: Filed May 13, 2005, effective Oct. 30, 2005. Moved to 20 CSR 2220-2.010, effective Aug. 28, 2006. Amended: Filed Aug. 21, 2006, effective April 30, 2007. Amended: Filed Feb. 6, 2008, effective Aug. 30, 2008. ** Amended: Filed Jan. 20, 2022, effective Aug. 30, 2022. *Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007, 2009, 2011, 2014, 2017, 2018, 2019, 2021; 338.140, RSMo 1939, amended 1981, 1989, 1997, 2011, 2019; 338.210, RSMo 1951, amended 2001, 2011, 2020; 338.240, RSMo 1951, amended 2011; and 338.280, RSMo 1951, amended 1971, 1981. **Pursuant to Executive Order 21-07, 20 CSR 2220-2.010, subsections (1)(A) and (1)(B) was suspended from March 20, 2020 through August 5, 2021.