Mississippi Administrative Code › Title 30 - Professions and Occupations › Part 3001 - MISSISSIPPI PHARMACY PRACTICE REGULATIONS › Article XXIX - REGULATIONS GOVERNING INSTITUTIONAL PHARMACY

Current through June 25, 2024
1.
			 APPLICABILITY: The following rules and regulations are applicable to all
			 pharmacies classified and authorized by permit to operate as institutional
			 pharmacies. All rules, regulations and laws which pertain to the practice of
			 pharmacy in the retail setting shall be applied to those aspects of
			 institutional practice which handle, prepare and dispense medications for use
			 outside the confines of the institution, except that none shall be construed to
			 prohibit the extension of a formulary system to outpatient dispensing.
2. REGISTRATION: No institutional
			 pharmacy shall be operated before it has been registered with the Mississippi
			 Board of Pharmacy and received an Institutional Permit in conformity with the
			 requirements of ARTICLE VI of the regulations of the Mississippi Board of
			 Pharmacy.
3. PERSONNEL:
A. Director. The Director of Pharmacy shall
			 be responsible for the safe and efficient distribution, control, and
			 accountability for drugs. The responsibilities of the director shall include
			 being responsible for and developing policies and procedures for the following:
(1) Preparation of sterile medications
			 prepared within the institutional facility;
(2) Admixture of parenteral products;
(3) Compounding of drugs,
			 solutions, ointments, lotions, etc.;
(4) To assure that no legend medication shall
			 be stored in patient care areas except upon the approval of the Director of
			 Pharmacy;
(5) Establishment of
			 specifications for procurement of all materials, including drugs, chemicals and
			 biologicals, subject to approval of the appropriate committee of the
			 institutional facility;
(6)
			 Participation in the development of a formulary for the institutional facility
			 where applicable;
(7) Dispensing
			 of all drugs dispensed within the institutional facility;
(8) Filling and labeling of all containers
			 from which drugs are to be administered;
(9) Maintenance of a sufficient inventory of
			 antidotes and other emergency drugs, both in the Pharmacy and in-patient care
			 areas, together with current antidote information, telephone numbers of
			 regional poison control centers and other emergency assistance organizations,
			 and such other materials and information as may be deemed necessary by the
			 appropriate committee of the institutional facility, if any;
(10) Maintenance of records of all
			 transactions of the institutional pharmacy as may be required by applicable
			 law, state and federal, and as may be necessary to maintain accurate control
			 and accountability for all pharmaceutical materials;
(11) Be responsible for "controlled
			 substances" within the institution from the time of purchase until they have
			 been administered to the patient; although individual pharmacists involved in
			 handling controlled substances share responsibility for control of these drugs;
(12) Assure that all drugs shall
			 be stored in areas within the institutional pharmacy and satellite storage
			 areas to provide proper sanitation, temperature, light, ventilation, moisture
			 control, segregation and security; that alcohol and flammables shall be stored
			 in areas separate and apart from areas used for storage, compounding or
			 dispensing; that disinfectants and drugs for external use are stored separately
			 and apart from drugs for internal use or ingestion; that outdated or other
			 unusable drugs are identified and stored in a manner that will prevent their
			 distribution or administration prior to disposition; that emergency drugs are
			 in adequate and proper supply at designated locations;
(13) Assure that all areas occupied by the
			 institutional pharmacy shall be capable of being locked to prevent unauthorized
			 access, and that all areas where drugs are stored or dispensed shall be locked
			 in the absence of pharmacy personnel;
(14) An institutional pharmacy shall have
			 sufficient floor space allocated to it to assure that drugs are prepared in
			 sanitary, well-lit and enclosed places;
(15) All drugs dispensed by an institutional
			 pharmacy intended for in-patient use shall be dispensed in appropriate
			 containers and shall be adequately labeled so as to identify, at a minimum,
			 brand or generic name, strength, acceptable route(s) of administration (only if
			 other than oral). The institution will maintain a system with control numbers
			 that will allow for recall of medication products. When a formulary is
			 maintained, a system shall be implemented to cross reference brand name and
			 generic products, and parenteral products that contain added drugs shall be
			 labeled with a distinctive supplementary label indicating the name and amount
			 of the drug added, expiration time, and name of person responsible for
			 compounding the admixture, and all drugs dispensed by an institutional pharmacy
			 for outpatient consumption shall comply with ARTICLE XIV;
(16) Insure that discontinued and outdated
			 drugs are returned to the pharmacy for proper disposition together with
			 containers with worn, illegible or missing labels. The director or his designee
			 shall properly dispose of such drugs;
(17) Drugs shall be dispensed from the
			 institutional pharmacy only upon receipt of a written or oral order or a direct
			 copy thereof. These may be in the form of carbon, NCR or electronically
			 transmitted orders (facsimile or computer generated). Orders shall be reviewed
			 by a pharmacist before the medication is initially dispensed except in
			 emergencies or when a pharmacist is unavailable. Medication orders must be
			 reviewed by a pharmacist within 24 hours or as soon thereafter as possible.
			 This regulation shall not be construed to prevent the distribution of drugs for
			 floor stock. Medication orders shall contain: patient name and room number,
			 drug name, strength, dosage, directions for use, date and the signature of the
			 practitioner or an authorized representative;
(18) Ensure that all requirements of the
			 Controlled Substances Act of 1970 and the requirements set forth in the
			 regulations of the Mississippi Board of Pharmacy in the purchasing, storing,
			 distribution, dispensing, record keeping and disposal of controlled substances
			 are met throughout the institution. The director or his designee shall
			 establish policies and procedures for the control of these drugs at all times,
			 including those instances when drugs are stored in surgery departments, nursing
			 stations, ambulatory clinics, diagnostic laboratories, etc. Periodic (at least
			 monthly) inspections of the proper storage of these drugs in other areas of the
			 institution is required and deficiencies must be corrected.
When controlled substances are stored in areas of the
				institution outside the pharmacy, the director shall assure that these drugs
				are inaccessible to unauthorized personnel.
Records of the administration of controlled substances shall
				be maintained for a period of not less than two years. Documentation of
				administration shall include the patient's name, medication, dosage,
				prescriber, the name of the person administering the drug and the date and time
				of administration.
A perpetual inventory shall be maintained on Schedule II
				controlled drugs. A perpetual inventory may be maintained on Schedule III, IV
				and V controlled drugs. If a perpetual inventory is not maintained on Schedule
				III, IV and V controlled drugs in the pharmacy, there must be the capability of
				a computer generated audit trail. Inventory audits shall be performed on a
				routine (at least daily) basis at all areas where controlled drugs are stocked
				outside the pharmacy. Records of periodic audits shall be maintained and made
				available for inspection by an agent of the Mississippi Board of Pharmacy; and
(19) Employment of
			 pharmacy technicians as required to operate such pharmacy competently, safely
			 and adequately to meet the needs of the patients of the institution; that no
			 pharmaceutical services shall be provided by pharmacy technicians unless
			 supervised by a pharmacist. It has been determined by the Board that three (3)
			 technicians on duty performing technician related work directly related to the
			 dispensing of medications are sufficient for each licensed pharmacist on
			 duty.