1921 INSTITUTIONAL PHARMACIES

1921.1 An institutional pharmacy shall be managed by a pharmacist (hereafter referred to as 'Director of Pharmacy ') who is licensed to practice pharmacy in the District of Columbia.1921.2 The Director of Pharmacy shall be a full-time employee of the institutional facility in which the institutional pharmacy is located, except that the Director of Pharmacy may be a part-time employee when the pharmacy department or service is not located on site and a formal agreement exists for the provision of pharmaceutical services to the institution.1921.3 The recordkeeping requirements of this section may be met by maintaining the most recent two years of records on site and the remaining three years of records off site as long as the records can be retrieved within three (3) business days of a request.1921.4 The Director of Pharmacy shall be responsible for, at a minimum, the following:- (a) Developing or ensuring that the institutional pharmacy meets all requirements set forth under applicable federal and District of Columbia laws and regulations;

- (b) Developing or adopting, and maintaining, and making available written policies and procedures that delineate the operation and activities of the provision of pharmacy services for the institution that ensure compliance with all applicable federal and District of Columbia laws and regulations;

- (c) Ensuring that the pharmacy maintains and makes available a sufficient inventory of antidotes and other emergency drugs, both in the pharmacy and in patient care areas, as well as current antidote information, telephone numbers of regional poison control centers, and other emergency assistance organizations, and other materials and information as may be deemed necessary by the appropriate committee of the institutional facility, if any;

- (d) Ensuring the provision of the appropriate level of pharmaceutical care services to patients of the institutional facility;

- (e) Ensuring that drugs and devices are prepared for distribution safely, and accurately as prescribed;

- (f) Ensuring a sufficient supply of drugs and devices to meet the needs of the patients of the institutional facility, and other appropriate equipment for

the preparation thereof;

1. (g) Developing or ensuring the establishment of a system for the compounding, sterility assurance, quality assurance, and quality control of sterile pharmaceuticals compounded within the institutional pharmacy;
2. (h) Developing or ensuring the establishment of a system to assure that all pharmacy personnel responsible for compounding or for supervising the compounding of sterile pharmaceuticals within the pharmacy receive appropriate education and training and competency evaluation;
3. (i) Ensuring the provision of written guidelines and approval of the procedures to assure that all pharmaceutical requirements are met when any part of preparing, sterilizing, and labeling of sterile pharmaceuticals is not performed under direct pharmacy supervision;
4. (j) Developing or ensuring the establishment of a system for bulk compounding or batch preparation of drugs;
5. (k) Ensuring that the pharmacy maintains records of all transactions of the institutional pharmacy as may be required by applicable federal or District of Columbia law or regulations, and as may be necessary to maintain accurate control over and accountability for all pharmaceutical materials;
6. (l) Ensuring that the records in a data processing system are maintained in compliance with federal and District of Columbia laws and regulations;
7. (m) Ensuring the automated medication dispensing system is operated and maintained in compliance with federal and District of Columbia laws and regulations;
8. (n) Maintaining and making available metric-apothecaries weight and measure conversion tables and charts to applicable personnel;
9. (o) Maintaining and making available current reference materials on toxicology, pharmacology, bacteriology, sterilization, and disinfection;
10. (p) Preparation and sterilization of parenteral medications compounded within the institutional facility;
11. (q) Ensuring the education and training of nursing personnel concerning incompatibility and provision of proper incompatibility information when the admixture of parenteral products is not accomplished within the institutional pharmacy;

(r) Developing or ensuring the establishment and implementation of policies and procedures to ensure that discontinued and outdated drugs, and containers with worn, illegible, or missing labels are returned to the pharmacy for proper disposition, or that the Director of Pharmacy, or his or designees, make proper disposition of such drugs at the storage site;

(s) Developing or ensuring the establishment of and implementation of a recall procedure to assure the medical staff and the pharmacy staff that all drugs included on the recall are returned to the pharmacy for proper disposition;

(t) Ensuring documentation of suspected and reported adverse drug reactions to the prescriber;

(u) Ensuring the making and maintaining of reports of suspected reactions to the FDA, to the manufacturer, and to the United States Pharmacopeia, and reporting of drug product defects accordingly;

(v) Developing or ensuring the establishment of procedures for an ongoing quality assurance program of pharmaceutical services that include a mechanism for reviewing and evaluating drug related patient care, as well as an appropriate response to findings;

(w) Notifying the Director of the occurrence of any of the following:

(1) Permanent closing of the pharmacy;

(2) Change of proprietorship, management, location, or pharmacist-in-charge of the pharmacy;

(3) Any theft or loss of prescription drugs or medical devices from the pharmacy;

(4) Conviction of any employee of the pharmacy of any federal, state, or District of Columbia drug laws;

(5) Disasters or accidents resulting in damage to the pharmacy facility, or inventory;

(6) Any theft, destruction, or loss of records required to be maintained by federal or District of Columbia law or regulation;

(7) Occurrences of significant adverse drug reactions; or

(8) Illegal use or disclosure of protected patient health information; and

(x) Ensuring the making or filing of any reports required by federal or District of Columbia laws or regulations.

1921.5 The Director of Pharmacy shall maintain the following records for a period of five (5) years:

(a) Physician's orders;

(b) Proofs of use of Schedule II controlled substances and any other drugs requested or required;

(c) Reports of suspected adverse drug reactions;

(d) Drug distribution records from night cabinets, automated medication dispensing systems, emergency kits, and similar systems;

(e) Inventories of the pharmacy;

(f) Inventories of controlled substances;

(g) Alcohol and flammable reports; and

(h) Any other records and reports as may be required by federal or District of Columbia law and regulations.

1921.6 In the event of an adverse drug reaction, an entry reflecting the reaction shall be made on the patient's pharmacy record.

1921.7 The Director of Pharmacy, at least once a month, shall inspect the pharmacy and all areas of the institution where drugs are stored or maintained, and make appropriate written records and notations of those inspections. An inspection shall verify that:

(a) Licensed pharmacists are responsible for all drugs dispensed and all prescription orders are checked by licensed pharmacists prior to leaving the pharmacy;

(b) Ancillary pharmacy personnel are properly directed and supervised;

1. (c) Drugs requiring special storage conditions are properly stored;
2. (d) Outdated drugs are retired from stock in the institutional pharmacy or the facility it serves;
3. (e) Controlled substances which have been distributed are properly and adequately documented and recorded by pharmacy personnel;
4. (f) Emergency medication kits are adequate and in proper supply both within the pharmacy and at outside storage locations; and
5. (g) Security and storage standards are met.1921.8 The Director of Pharmacy shall be assisted by a sufficient number of additional licensed pharmacists as may be required to operate the institutional pharmacy competently, safely, and adequately to meet the needs of the patients of the facility.1921.9 Trained technical and administrative personnel may be employed in a support capacity in institutional pharmacies, provided that the support activities are performed under the supervision of a pharmacist.1921.10 Areas occupied by an institutional pharmacy shall be capable of being locked by key or combination to prevent access by unauthorized personnel.1921.11 An institutional pharmacy, or any part thereof, shall be locked in the absences of personal and direct supervision by authorized personnel.1921.12 The Director of Pharmacy shall designate in writing, by title and specific area, those persons who have access to particular areas within the pharmacy during non-business hours of the pharmacy.1921.13 Authorized persons may have access to designated areas in the institutional pharmacy, and may remove drugs in compliance with the institution's established policies and procedures.1921.14 Personnel authorized to have access to designated areas in the institutional pharmacy, shall receive thorough education and training in the proper methods of access, removal of drugs, and records and procedures required, prior to being permitted access to those areas of the pharmacy.1921.15 The Director of Pharmacy or his or her designee shall administer the education and training required by § 1921.14 of this chapter.1921.16 Removal of any drug from the pharmacy by an authorized person shall be

recorded on a suitable form showing the patient's name, identification number, room number, name of the drug, strength, amount, date, time and the signature of the authorized person. The form shall be left with the container from which the drug was removed.

1921.17 During the times that an institutional pharmacy may be unattended by a licensed pharmacist, arrangements shall be made in advance by the Director of Pharmacy for provision of drugs to the licensed medical staff and other authorized personnel of the institutional facility by use of night cabinets, automated medication dispensing systems, telepharmacy systems, or by similar means, and in emergency circumstances, by access to a designated area of the pharmacy by persons authorized to handle, manage, or administer medication. A pharmacist shall be "on call" during all absences.

1921.18 If night cabinets are used, the following procedures shall be used:

(a) In the absence of a licensed pharmacist, drugs shall be stored in a locked cabinet or other enclosure constructed and located outside of the pharmacy area, to which only specifically authorized personnel may obtain access by key or combination, and which is sufficiently secure to deny access to unauthorized persons by force or otherwise;

(b) The Director of Pharmacy, in conjunction with the appropriate committee of the institutional facility, shall develop inventory listings of those drugs to be included in night cabinets and shall ensure that:

(1) All drugs available in the cabinet or similar container are properly stored and labeled; and

(2) Only prepackaged drugs are available, in amounts sufficient for immediate therapeutic requirements;

(3) Whenever access to the cabinet occurs, written practitioners' orders and proofs-of-use are provided to the pharmacist by the start of the business the following business day;

(4) All drugs therein are inventoried no less than once per week;

(5) A complete audit of all activity concerning the cabinet is conducted no less than once per month; and

(6) Written polices and procedures are established to implement the requirements of this subsection.

1921.19 Whenever any drug is not available from floor supplies, night cabinets, automated medication dispensing systems, telepharmacy systems, or by similar means, and the drug is required to treat the immediate needs of a patient whose health would otherwise be jeopardized, the drug may be obtained from the pharmacy in accordance with the following requirements:- (a) One (1) supervisory registered professional nurse, and only one (1), in any given eight (8) hour shift is responsible for obtaining drugs from the pharmacy. The responsible nurse shall be designated in writing by the appropriate committee of the institutional facility. The responsible nurse may, in times of emergency, delegate this duty to another licensed registered nurse;

- (b) The responsible nurse shall, prior to being permitted to obtain access to the pharmacy, receive thorough education and training in the proper methods of access, removal of drugs, and records and procedures; and

- (c) The Director of Pharmacy or his or her designee shall administer the education and training required in subsection (b) of this section.1921.20 Removal of any drug from the pharmacy by an authorized nurse shall be recorded on a suitable form showing the patient's name, room number, name of the drug, strength, amount, date, time and the signature of the nurse. The form shall be left with the container from which the drug was removed.1921.21 Investigational drugs shall be stored in and dispensed from the pharmacy only by a pharmacist. All information with respect to investigational drugs shall be maintained in the pharmacy.1921.22 For an institutional facility that does not have an institutional pharmacy, drugs may be provided for use by authorized personnel by emergency kits located at the facility, provided the following requirements are met:- (a) The pharmacist-in-charge at the provider pharmacy shall determine, in consultation with the medical and nursing staff of the facility, which drugs and what quantity of those drugs should be included in the emergency kit and prepare the kit for use only by those persons licensed or authorized to administer drugs;

- (b) The emergency kit shall contain the drugs required to meet the immediate therapeutic needs of patients and which are not available from any other authorized source in sufficient time to prevent risk of harm to patients by delay resulting from obtaining such drugs from such other sources;

1. (c) The emergency kit shall be sealed with a tamper evident seal, and stored in a secured area to prevent unauthorized access by force or otherwise, and to ensure a proper environment for preservation of the drugs inside the kit;
2. (d) The exterior of the emergency kit shall be labeled so as to clearly indicate that it is an emergency drug kit and that it is for use in emergencies only. The label shall contain a listing of the drugs contained in the kit, including the name, strength, quantity, and expiration date of the contents, and the name, address, and telephone number of the pharmacy who prepared the kit;
3. (e) All drugs contained in an emergency kit shall be labeled with the necessary information required by the medical staff of the institutional facility to prevent misunderstanding or risk of harm to the patients;
4. (f) Drugs shall be removed from emergency kits only pursuant to a valid written or verbal order by an authorized prescriber;
5. (g) Whenever an emergency kit is opened, the provider pharmacist shall be notified and the pharmacist shall restock and reseal the kit as soon as possible, but not more than seventy-two (72) hours after notification. In the event the kit is opened in an unauthorized manner, the pharmacist and other appropriate personnel of the facility shall be notified;
6. (h) The expiration date of an emergency kit shall be the earliest date of expiration of any drug supplied in the kit. Upon the occurrence of the expiration date, the provider pharmacist shall replace the expired drug; and
7. (i) The provider pharmacist shall, in conjunction with the medical staff of the institutional facility, develop and implement written policies and procedures to ensure compliance with the provisions of this subsection, and other applicable federal and District of Columbia laws and regulations.1921.23 Drugs shall be dispensed from the institutional pharmacy only pursuant to the valid prescription order of an authorized practitioner.1921.24 The Director of Pharmacy shall maintain a listing, including signatures, of those practitioners who are authorized to issue orders to the institutional pharmacy.1921.25 Drugs brought into an institutional facility by a patient shall not be administered unless they can be identified by the pharmacist and the quantity and quality of the drug assured.

1921.26 The Director of Pharmacy shall develop or ensure the establishment and implementation of policies and procedures to ensure that if drugs brought into an institutional facility by a patient are not to be administered, that they are properly returned to an adult member of the patient's immediate family.1921.27 Prescription drug orders for use by inpatients of the facility shall contain the following information:- (a) Patient name, identification number, and room number;

- (b) Drug name;

- (c) Drug strength;

- (d) Directions for use and route of administration;

- (e) Date and physician's signature, or signature of his or her authorized representative; and

- (f) The words 'Patient May Use Own Medications' when the prescription drug order is being written for drugs brought into the institution by the patient pursuant to § 1921.25.1921.28 Prescription drug orders for use by outpatients shall, in addition to the information items required by § 1921.27, contain the patient's address, the facility's address, and DEA registration number, if applicable.1921.29 Drugs dispensed for use by inpatients of an institutional facility, whereby the drug is not in the possession of the ultimate user prior to administration, shall be dispensed in appropriate containers and adequately labeled to meet the following requirements:- (a) The label of a single-unit package of an individual-dose or unit-dose system of packaging of drugs shall include:

- (1) The generic, chemical, or brand name of the drug;

- (2) The route of administration, if other than oral;

- (3) The strength and volume, where appropriate,

- (4) The control number or lot number, and expiration date;

(5) Identification of the repackager by name or by license number and shall be clearly distinguishable from the rest of the label; and

(6) Special storage conditions, if required.

(b) When a multiple-dose drug distribution system (i.e. blister cards) is utilized, including dispensing of single unit packages, the drugs shall be dispensed in a container to which is affixed a label containing the following information:

(1) Identification of the dispensing pharmacy;

(2) The patient's name;

(3) The date of dispensing;

(4) The generic, chemical, or brand name of the drug dispensed; and

(5) The drug strength.

1921.30 All drugs dispensed to inpatients for self administration, and all drugs dispensed to ambulatory or outpatients, shall contain a label affixed to the container indicating:

(a) The name and address of the pharmacy dispensing the drug;

(b) The name of the patient for whom the drug is prescribed; or, if the patient is an animal, the name of the owner, name of the animal, and the species of the animal;

(c) The name of the prescribing practitioner;

(d) Such directions as may be stated on the prescription drug order;

(e) The date of dispensing;

(f) Any cautions which may be required by federal or District of Columbia law,

(g) The serial number or prescription number of the prescription drug order;

(h) The name or initials of the dispensing pharmacist;

(i) The generic, chemical, or brand name of the drug dispensed;

(j) The strength, dosage, and quantity of the drug dispensed;

(k) The name of the manufacturer or distributor of the drug; and

(l) The expiration date.

1921.31 Beginning six (6) months after the effective date of these regulations, pharmacies engaged in the practice of compounding and dispensing of any drugs shall comply with the standards set forth in the current published edition of USP General Chapters 795, 797, and 800 relevant to the type of compounding and dispensing undertaken.

1921.32 [REPEALED]

1921.33 In addition to existing labeling requirements, parenteral product labels shall include:

(a) Telephone number of the pharmacy;

(b) Name and concentrations of all ingredients contained in the parenteral product, including primary solution;

(c) Instructions for storage and handling; and

(d) A label for all cytotoxic agents which shall state: "Chemotherapy - Dispose of Properly".

1921.34 Pharmacies engaged in the practice of compounding and dispensing of parenteral solutions shall have on the premises, or readily accessible, a patient record for each patient being treated with parenteral therapy. In addition to existing recordkeeping requirements, the following records shall be maintained in the pharmacy:

(a) Records of the furnishing of all prescriptions and medical supplies;

(b) Progress notes documenting contact with the patient or physician relative to parenteral therapy; and

(c) Other data relevant to parenteral therapy.

1921.35 [REPEALED]

1921.36 The Director of pharmacy shall ensure that all pharmacists engaging in compounding parenteral solutions have training or have demonstrated previous

training in the safe handling and compounding of parenteral solutions, including cytotoxic agents.

1921.37 Beginning six (6) months after the effective date of these regulations, pharmacies providing parenteral services shall have written policies and procedures for the disposal of infectious materials, materials containing cytotoxic residues, and all preparations and waste that may be produced or used in compounding or the final product. The procedures shall include cleanup of spills and shall conform with applicable District of Columbia and federal law and regulations as well as the current published editions of USP General Chapters 795, 797, and 800 as applicable.

1921.38 The pharmacist or their designated individual is responsible for developing and maintaining a quality assurance program that insures a clean and sanitary environment for the preparation of sterile products and ensures that the parenteral products that are produced are sterile. The pharmacist or their designated individual is required to develop and implement a training program to be completed by all sterile compounders under their supervision concerning the implementation of the quality assurance program. Documentation of these activities, including, but not limited to, a written training program and tests used to demonstrate familiarity of the quality assurance program requirements, shall be available to the Director.

1921.39 [REPEALED]

1921.40 [REPEALED]

1921.41 [REPEALED]

SOURCE: Final Rulemaking published at 38 DCR 6734, 6753 (November 8, 1991); as amended by Notice of Final Rulemaking published at 55 DCR 270 (January 11, 2008); as amended by Notice of Final Rulemaking published at 57 DCR 10518 (November 12, 2010); as amended by Final Rulemaking published at 69 DCR 002763 (April 1, 2022).