Missouri Code of State Regulations › Title 20 - DEPARTMENT OF COMMERCE AND INSURANCE › Division 2220 - State Board of Pharmacy › Chapter 2 - General Rules › Section 20 CSR 2220-2.010 - Pharmacy Standards of Operation

Current through Register Vol. 49, No. 14, July 15, 2024
PURPOSE: This amendment updates standards of
				  operation requirements for all pharmacies permitted by the
				  Board.
(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, non-resident 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
				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 licensees/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-in-charge 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.