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. (1) The word medicine or medicines is a word similar or of like import to the words pharmacist, pharmacy, apothecary shop, chemist shop, drug store, druggist and drugs, and no person shall carry on, conduct or transact a business under a name which contains, as part of the name, the word medicine or medicines, unless the place of business is supervised by a licensed pharmacist.

   1. (A) At all times when prescriptions are compounded in a pharmacy or other establishments holding a Missouri pharmacy permit, there shall be on duty and present in that place of business a pharmacist licensed in Missouri as provided by law. In any Class J: Shared Service pharmacy where a permit is maintained at a location for the purpose of remote dispensing as defined in 20 CSR 2220-2.900 the pharmacist may be considered on duty and present as long as all required electronic connection requirements are maintained and the pharmacist is accessible at all times to respond to patient’s or other health professionals’ inquiries or requests pertaining to drugs dispensed through the use of the automated pharmacy system. When there is no pharmacist on duty, no prescription will be compounded, dispensed or otherwise provided and the public will be advised that no pharmacist is on duty by means of signs stating this fact. The signs will be displayed prominently on the doors of all entrances and the prescription counter of the pharmacy and the signs will be composed of letters of a minimum height of two inches (2").
   2. (B) Whenever, in a pharmacy or other establishment holding a Missouri pharmacy permit, a person other than a licensed pharmacist does compound, dispense or in any way provide any drug, medicine or poison pursuant to a lawful prescription, a licensed pharmacist must be physically present within the confines of the dispensing area, able to render immediate assistance and able to determine and correct any errors in the compounding, preparation or labeling of that drug, medicine or poison before the drug, medicine or poison is dispensed or sold. In any Class J: Shared Service pharmacy where a permit is maintained at a location for the purpose of remote dispensing as defined in 20 20 CSR 2220-2

CSR 2220-2.900 the pharmacist may be considered on duty and present as long as all required electronic connection requirements are maintained and the pharmacist is accessible at all times to respond to patient’s or other health professionals’ inquiries or requests pertaining to drugs dispensed through the use of the automated pharmacy system. The pharmacist personally shall inspect and verify the accuracy of the contents of, and the label after it is affixed to, any prescribed drug, medicine or poison compounded or dispensed by a person other than a licensed pharmacist.

1. (C) No pharmacy shall be licensed under the provisions of this chapter unless it is equipped with proper pharmaceutical equipment and reference manuals. Requirements for proper equipment and references may vary between pharmacies and must insure accuracy and safety of all pharmaceutical activity.

   1. 1. Basic equipment recognized by the

latest edition of the United States Pharmacopoeia (USP), the United States Pharmacopoeia/Drug Information (USP/DI) or Remington’s Pharmaceutical Sciences shall be available for any procedures utilized in the dispensing, compounding or admixture of drugs and drug-related devices, and must maintain conformance with these publications.

1. 2. A suitable machine or electronic data

device for the numbering of all prescriptions must be maintained along with appropriate printing equipment for the production of prescription drug labels.

1. (D) Reference manuals may include any generally recognized pharmaceutical publication other than periodicals or journals. A pharmacy must maintain, at a minimum, the current or latest edition of a reference manual(s) which includes all Federal Drug Administration (FDA)-approved drugs. The following topics must be included in the reference(s) selected:

   1. 1. Pharmacology of drugs;
   2. 2. Dosages and clinical effects of drugs;

and

1. 3. Patient information.
2. (E) Pharmacies shall maintain at least one

1. (1) current edition of statutes and rules governing the pharmacy’s practice.

   1. (F) All pharmacies shall be maintained in a clean and sanitary condition at all times. Any procedures used in the dispensing, compounding and admixture of drugs or drugrelated devices must be completed under clean and, when recommended, aseptic conditions.

      1. 1. Appropriate sewage disposal and a

hot and cold water supply within the pharmacy must be available. AND INSURANCE

1. 2. Appropriate housekeeping and sanita-

tion of all areas where drugs are stored or dispensed must be maintained.

1. 3. Animals, except for service animals

as defined by the Americans with Disabilities Act (ADA), are not allowed in pharmacies.

1. (G) The temperature of the facility where drugs are stored must be maintained thermostatically within temperature requirements as provided for by the manufacturer or the latest edition of the USP. Adequate refrigeration must be available to insure enough storage space for drugs requiring refrigeration or freezing and under temperatures adequate to maintain the drug products as recommended by the manufacturer, the latest edition of the USP, or both. Drugs and drug-related devices must be stored separately from food and other items.
2. (H) Pharmacies must maintain adequate security in order to deter theft of drugs by personnel or the public. Sufficient alarm systems or locking mechanisms must be in place if the pharmacy is located in a facility into which the public has access and the pharmacy’s hours of operation are different from those of the remainder of the facility.

3. (I) Pharmacies which maintain storage sites or warehouse facilities for the storage of pharmaceuticals at a separate address or premises from the main pharmacy that holds a pharmacy permit shall register those sites as storage facilities of the licensed pharmacy. Information required for proper registration of a storage facility shall include the address of the facility, hours of operation (if applicable), pharmacy permit numbers of the pharmacies that it services, and a certified statement that the facility is used for the sole purpose of distributing drugs only within its own pharmacy operations.

   1. 1. Records must be maintained at these

facilities to guarantee security, storage and accountability of all drugs and drug-related devices under proper conditions.

1. 2. All storage and warehouse locations

will be considered facilities of a pharmacy pursuant to section 338.240, RSMo and shall be subject to inspection by the board as defined in section 338.150, RSMo.

1. 3. No fee will be charged by the board

for registering a facility as defined in subsection (1)(I) of this rule.

1. (J) Pharmacies that maintain storage sites or warehouse facilities for the storage of confidential pharmacy records at a separate address or premises from the main pharmacy that holds a pharmacy permit shall register those sites as storage facilities of the licensed pharmacy. Information required for proper registration of a storage facility shall include the address of the facility, hours of operation (if applicable), pharmacy permit numbers of the pharmacies that it services, and a statement that the facility is used for the sole purpose of storing records within its own pharmacy operations.

   1. 1. All storage and warehouse locations

must maintain adequate security including an alarm system. Any breach in security must be documented and reported in writing via facsimile, email communication, or letter to the board within fifteen (15) days of the breach of confidentiality.

1. 2. All storage and warehouse locations

will be considered facilities of a pharmacy pursuant to section 338.240, RSMo and shall be subject to inspection by the board as defined in section 338.150, RSMo.

1. 3. No fee will be charged by the board

for registering a facility as defined in subsection (1)(J) of this rule.

1. 4. All storage and warehouse locations

must comply with 19 CSR 30-1.

1. 5. No records less than two (2) years old

may be stored offsite.

1. 6. All storage and warehouse locations

storing confidential pharmacy records must make records retrievable within two (2) business days when requested by the board or its representatives.

1. (K) All pharmacists will be required to have a photo of themselves not smaller than two inches by two inches (2" × 2") in the upper right-hand corner of the current renewal licenses. This photo and license renewal shall be conspicuously exposed in the pharmacy or drug store or place of business in which the pharmacist is employed as required by law.
2. (L) Pharmacists regularly working as relief persons for more than one (1) store shall have in their possession proper identification of their pharmacy licensure.
3. (M) Pharmacy operations must be conducted at all times under the supervision of a properly designated pharmacist-in-charge. When a licensed pharmacist leaves the employment of a pharmacy where s/he has been pharmacist-in-charge, s/he immediately shall notify the executive director of the board of the termination of his/her services in the pharmacy. Likewise, the holder of the permit shall notify the executive director of the board of the termination of the services and give the name of the new licensed pharmacist-in-charge.
4. (N) Pharmacists are responsible to inform the executive director of the board in the case of changed address. Any mail or communications returned to the executive director’s office marked Unknown, Incorrect Address, and the like, will not be sent out a second time until the correct address is sent in.
5. (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.

6. (P) When required by section 338.013(10), RSMo, to report technician disciplinary action, the pharmacy must notify the board in writing within fifteen (15) days of the action. The notification must include:

   1. 1. The name and permit number of

pharmacy;

1. 2. Name of person making the notifica-

tion;

1. 3. Name of technician;
2. 4. Technician registration number;
3. 5. Date of action; and
4. 6. Reason for action.
5. (Q) Pharmacists must inform the executive director of the board of any change in their employment address. The notification of an employment change must be provided in writing to the board no later than fifteen (15) days following any effective change.

1. (2) Every pharmacy shall designate as its primary means of record keeping either a manual system which provides for the consecutive numbering of hard copy prescriptions and complies with the provisions of section (3) of this rule or an electronic system which complies with the provisions of 20 CSR 2220- 2.080. The designated record system shall be used to record the pharmacy’s dispensing of all drugs, medicines and poisons.

2. (3) A pharmacy using a record keeping system other than an electronic system meeting the requirements of 20 CSR 2220-2.080 to record its dispensing of drugs, medicines and poisons shall provide a method of recording all of the following information concerning the refill of any prescription medication on the back or reverse side of every prescription order:

   1. (A) The date the drug, medicine or poison was dispensed;
   2. (B) The dispensing pharmacist’s initials; and
   3. (C) The amount of drug, medicine or poison dispensed to the patient if different from the amount on the face of the prescription order.

3. (4) Each licensed pharmacy shall maintain at least three (3) separate files of prescriptions and they shall be as follows:

   1. (A) All prescriptions for controlled drugs listed in Schedules I and II shall be maintained in a separate prescription file;
   2. (B) All prescriptions for controlled drugs listed in Schedules III, IV and V shall be maintained in a separate prescription file; and
   3. (C) All other prescriptions for noncontrolled drugs shall be maintained in a separate prescription file(s).
4. (5) Pharmacies shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of legend drugs. Said records shall be maintained for two (2) years and be readily retrievable upon request by the board or its representatives.
5. (6) Drugs and devices that are maintained as part of the pharmacy inventory or are being processed for dispensing or other distribution purposes must be physically separated at all times from articles, supplies or other drugs that are for employee personal use or that are outdated, distressed, misbranded or adulterated. An area separate from drug storage must be used to store quarantined, nonusable substances. Areas used for this type of drug storage must be clearly identified. Any prescription drugs that are present in a licensed pharmacy but are for the personal use of pharmacy personnel must be labeled in accordance with section 338.059, RSMo.
6. (7) All records required by Chapters 195 and 338, RSMo or divisions 20 CSR 2220 and 19 CSR 30 shall be available for photocopying or electronic duplication by a board of pharmacy representative.
7. (8) Except as provided for in section 21 U.S.C. section 353(d)(1)(A)–(C), (d)(2)(A)(i)–(ii), (d)(2)(B)(i)–(iv), and (d)(3)(A)(i)–(ii) of the Federal Food, Drug and Cosmetic Act, drug samples shall not be maintained in pharmacies.

8. (9) 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.

   1. (A) The list of drugs that may be possessed by a home health or hospice agency without a license or permit, as defined in section (9), is as follows:

      1. 1. Injectable dosage forms of sodium

chloride and water;

1. 2. Irrigation dosage forms of sodium

chloride and water that carry a federal prescription only restriction;

1. 3. Injectable dosage forms of heparin

and alteplase in concentrations that are indicated for maintenance of venous access devices;

1. 4. Injectable dosage forms of diphenhy-

dramine and epinephrine;

1. 5. Vaccines indicated for public health

needs, such as influenza, pneumonia, hepatitis A and hepatitis B; and

1. 6. Tuberculin test material.

2. (B) The agency shall have a policy and procedure that addresses at least the following:

   1. 1. Specific drugs authorized to be pos-

sessed by the agency and the nurse;

1. 2. Indications for use of the drugs pos-

sessed;

1. 3. Receiving physicians’ orders for

administration of the drugs;

1. 4. Leaving drugs with the patient for

routine care procedures;

1. 5. Conditions for storage and transport

of the drugs by the agency and the nurse; and

1. 6. Quantity of drugs possessed by the

agency and the nurse.

1. (C) The nurse must have a physician’s authorization, such as an individual patient order, protocol or standing order, to administer the drugs.
2. (D) When the patient or the patient’s representative has been instructed, verbally and in writing, in the performance of routine care procedures, up to a two (2)-week supply of sodium chloride, water, and heparin may be left with the patient for these procedures. 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.
3. (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. Refrigerator units used by the agency for storing drugs shall not be used for storing nondrug items.
4. (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.

1. (10) Class I: Consultant Pharmacies as defined in 20 CSR 2220-2.020(9)(I) and approved by the board to be located within a residence shall be required to address and comply with the following minimum standards of practice:

   1. (A) Location Requirements—

      1. 1. The pharmacy must be located in a

separate room that provides for a door with 20 CSR 2220-2

suitable lock;

1. 2. Sufficient storage for securing confi-

dential documents and any hardware used in accessing a central pharmacy by electronic connection must be provided;

1. 3. Ceiling and walls must be constructed

of plaster, drywall, brick or other substantial substance that affords a design that makes the room separate and distinct from the remainder of the domicile. Drop down ceilings that allow access into the room are not allowed;

1. 4. All locations must be inspected and

have approval by the board prior to the initiation of services; and

1. 5. Patients are not allowed in the phar-

macy.

1. (B) Documentation—

   1. 1. Maintain a current policy and proce-

dure manual that is attested by the signature and date of review of the pharmacist-incharge to its accuracy. All pharmacists working at the pharmacy shall be required to sign the manual attesting to their review and understanding of all policies and procedures in force;

1. 2. Maintain documentation that the per-

mit holder has provided training to all personnel on all operations associated with the pharmacy;

1. 3. The permit holder must complete an

audit to ensure compliance with pharmacy policy and procedures and this regulation at a minimum of twice per year, through physical visits by representatives of the permit holder. Audit results must be maintained by the permit holder for a period of three (3) years; and

1. 4. If the pharmacist is working under a

contract for the permit holder, a copy of the contract shall be available during an inspection.

1. (C) Security—Records and Internet—

   1. 1. All electronic data processing systems

must meet all applicable state and federal confidentiality laws and regulations;

1. 2. Data processing systems must utilize

sufficient security software;

1. 3. Any breach in the security of the sys-

tem must be documented and reported to the board of pharmacy within seven (7) days of the breach of confidentiality. Such documentation shall be available during an inspection.

1. (D) Licensure and Inspection—

   1. 1. Each location must maintain and dis-

play a current Class I permit. The permit holder for this permit must be the pharmacy the individual pharmacist is employed by or contracted with;

1. 2. Routine inspections for in-state phar-

macies shall be arranged ahead of time. Notification by the inspector to the permit holder will be provided a minimum of seventy-two AND INSURANCE

1. (72) hours ahead of the scheduled inspection. The permit holder must arrange for a designated representative to be present that is not a resident of the location under inspection;

   1. 3. A pharmacy located outside the state

must maintain a pharmacist-in-charge with a current and active pharmacist license with the state of Missouri;

1. 4. The audits required in paragraph

(10)(B)3. shall be available for review during the inspection; and

1. 5. The pharmacy shall provide copies of

inspections completed by the state in which they are located if such inspections are required within seven (7) business days of the inspection date.

AUTHORITY: sections 338.140, 338.240, and 338.280, RSMo 2000 and sections 338.010 and 338.210, RSMo Supp. 2007.* 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. **

*Original authority: 338.010, RSMo 1939, amended 1951, 1989, 1990, 2007; 338.140, RSMo 1939, amended 1981, 1989, 1997; 338.210, RSMo 1951, amended 2001; 338.240, RSMo 1951; and 338.280, RSMo 1951, amended 1971, 1981. **Pursuant to Executive Orders 20-04 and 20-10, 20 CSR 2220- 2.010, subsections (1)(A) and (1)(B) was suspended from March 20, 2020 through June 15, 2020.