# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 23 — Pharmaceutical Services to Patients in Comprehensive Care Facilities

**Authority:** Health Occupations Article, §§12-205, 12-301, 12-401, 12-403, 12-501, 12-503, 12-504, 12-505, 12-506, and 12-6B-01, Annotated Code of Maryland

**Administrative History:** Effective date: October 7, 1996 (23:20 Md. R. 1424)

**Administrative History:** Chapter revised effective June 1, 2011 (38:11 Md. R. 671)

**Administrative History:** Regulation .03E amended effective September 16, 2013 (40:18 Md. R. 1479)

**Administrative History:** Regulation .07D, E amended effective April 2, 2012 (39:6 Md. R. 408)

**Administrative History:** Regulation .08B amended effective April 2, 2012 (39:6 Md. R. 408)

**Administrative History:** Regulation .09G amended effective September 16, 2013 (40:18 Md. R. 1479)

#### Regulation .01 Scope.

*COMAR 10.34.23.01*

This chapter applies to pharmacies and licensed pharmacists serving comprehensive care facilities as defined in Regulation .02 of this chapter, except for pharmacies providing only emergency services for these facilities.

#### Regulation .02 Definitions.

*COMAR 10.34.23.02*

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

  (1) “Chart order” means a lawful order entered on the chart or a medical record of a patient of a comprehensive care facility by an authorized prescriber or the authorized prescriber’s designated agent for a drug or device.

  (2) Comprehensive Care Facility.

    (a) “Comprehensive care facility” means a facility which admits patients suffering from disease, disabilities, or advanced age, requiring medical service and nursing service rendered by or under the supervision of a registered nurse.

    (b) “Comprehensive care facility” does not mean an establishment which provides only:

      (i) Acute care; or

      (ii) Assisted living care.

  (3) “Emergency drug kit” means a container or electronic storage system containing medications which:

    (a) May be required for the emergency need of a patient; and

    (b) Are not available from an authorized source in a timely manner.

  (4) “Interim box” means a container or an electronic system holding minimal quantities of medications:

    (a) Agreed upon by the comprehensive care facility’s pharmaceutical services committee, as defined in COMAR 10.07.02.15; and

    (b) Intended to expedite immediate initiation of emergency or nonemergency dosing until the pharmacy is able to provide a regular supply.

  (5) “Licensed pharmacist” means a pharmacist who is licensed by the Board to practice pharmacy.

  (6) “Packaging” means the process by which a medication is:

    (a) Removed from a:

      (i) Non-patient specific manufacturer’s original container; or

      (ii) Patient specific container directly received from another pharmacy licensed in Maryland or operated by the government of the United States provided that the manufacturer’s name is present on the container; and

    (b) Placed into a new container by a licensed pharmacist or registered pharmacy technician under the supervision of a pharmacist.

  (7) “Pharmaceutical services” means the care within practice standards, laws, regulations, and guidelines which is afforded by a licensed pharmacist to the patients of a comprehensive care facility.

  (8) “Pharmacy” means a holder of a pharmacy permit issued by the Board, located either on the premises of or outside the comprehensive care facility and which provides pharmaceutical services to patients in a comprehensive care facility.

  (9) “Pharmacy area” means that portion of the licensed pharmacy where medication and other products requiring a prescription by federal or State law are stored and where the prescriptions are compounded or prepared.

  (10) “Registered pharmacy technician” means an individual who is registered with the Board to perform delegated pharmacy acts.

  (11) “Verbal order” means a directive that is orally communicated to a licensed pharmacist to accept a prescription order by a person who is authorized to communicate a prescription.

  (12) “Written order” means a directive that is directly written by an authorized prescriber or a transcription of an order from an authorized prescriber by a person authorized to transcribe an order.

#### Regulation .03 Policies and Procedures.

*COMAR 10.34.23.03*

The permit holder shall establish and operate under a policies and procedures manual which:

A. Complies with this chapter;

B. Defines the scope and method of pharmacy services provided to the patients of the comprehensive care facility;

C. Determines when personnel may have access to the pharmacy area;

D. Provides for the safe and efficient dispensing and delivery of pharmaceutical products as outlined in this subtitle;

E. Includes:

  (1) Labeling requirements and distribution methods for medication provided in a single container, slot, blister package, or other method of delivering an entire single dosing unit; and

  (2) The conditions in which an interim box may be replenished or prepared, delivered, and stored by the comprehensive care facility in accordance with Regulation .09 of this chapter;

F. Is provided to:

  (1) The personnel of the pharmacy;

  (2) The comprehensive care facility; and

  (3) Upon request, an agent of the Board; and

G. Is in a form that is:

  (1) Written or electronic; and

  (2) Readily retrievable.

#### Regulation .04 Personnel.

*COMAR 10.34.23.04*

A. Director of Pharmacy. The permit holder shall appoint a licensed pharmacist as director of pharmacy who is:

  (1) Licensed to engage in the practice of pharmacy in Maryland;

  (2) Knowledgeable in, and thoroughly familiar with, the specialized functions of comprehensive care facility pharmaceutical services;

  (3) Responsible for and in full and actual charge of the pharmacy and its personnel;

  (4) Responsible for the operations of the pharmacy and for compliance with the requirements of Health Occupations Article, Title 12, Annotated Code of Maryland, and the regulations promulgated under that title;

  (5) Responsible for reviewing the policies and procedures manual of the pharmacy annually and revising it as necessary;

  (6) On site full time; and

  (7) Responsible for only one comprehensive care pharmacy.

B. Staff.

  (1) The permit holder:

    (a) May employ registered pharmacy technicians as required to provide pharmaceutical services to the patients of the comprehensive care facilities; and

    (b) Shall provide policies and procedures that specify the duties that may be performed by registered pharmacy technicians under the supervision of a licensed pharmacist and the duties that may be performed only by a licensed pharmacist.

  (2) The permit holder may employ unlicensed personnel to provide operational support as defined in COMAR 10.34.21.02B.

#### Regulation .05 Physical Requirements.

*COMAR 10.34.23.05*

A. Storage. The director of pharmacy or designee shall ensure that medications and supplies within the pharmacy are properly stored according to the manufacturer’s specifications and State and federal laws and regulations with respect to:

  (1) Sanitation;

  (2) Temperature;

  (3) Light;

  (4) Ventilation;

  (5) Moisture control;

  (6) Segregation; and

  (7) Security.

B. Equipment and Materials.

  (1) The director of pharmacy or designee shall ensure that the pharmacy contains appropriate:

    (a) Equipment;

    (b) Supplies; and

    (c) Physical facilities for proper compounding, preparation, and dispensing of medications as outlined in COMAR 10.34.19.

  (2) The director of pharmacy or designee shall ensure that the pharmacy contains appropriate reference materials to enable personnel to prepare and dispense medications properly as outlined in COMAR 10.34.07.

C. Security.

  (1) The director of pharmacy or designee shall ensure that no individual enters the pharmacy area unless a licensed pharmacist is on duty.

  (2) The permit holder and the director of pharmacy or designee shall ensure compliance with COMAR 10.34.05.

#### Regulation .06 Medication and Device Distribution and Pharmaceutical Services.

*COMAR 10.34.23.06*

A. The director of pharmacy or designee shall be responsible for the safe and efficient dispensing, delivery, control of, and accountability for medications and devices dispensed or distributed by the permit holder.

B. The director of pharmacy or designee shall work in cooperation with the professional staff of the comprehensive care facility in:

  (1) Meeting the responsibilities set forth in §C of this regulation; and

  (2) Ordering, storing, and accounting for pharmaceutical materials.

C. The director of pharmacy or designee shall be responsible for, at a minimum:

  (1) The preparation of medications compounded in the pharmacy as applicable;

  (2) The proper preparation, storage, and distribution of compounded sterile preparations according to  COMAR 10.34.19 to the extent that the functions are performed at the pharmacy;

  (3) The packaging and labeling of medications;

  (4) Records of transactions of the pharmacy as may be required by applicable law and as may be necessary to maintain accurate control over and accountability for pharmaceuticals, including patient medication profiles;

  (5) Participation in those aspects of the comprehensive care facility's quality assurance improvement program which relate to pharmaceutical care and effectiveness; and

  (6) Implementation of the policies and decisions of the appropriate committee or committees of the comprehensive care facility related to these regulations and to other regulations of the facility.

#### Regulation .07 Medication Packaging.

*COMAR 10.34.23.07*

A. A licensed pharmacist shall verify the:

  (1) Selection of medication to be packaged; and

  (2) Completed packaging of medication performed by registered pharmacy technicians for the following:

    (a) Accuracy;

    (b) Completeness;

    (c) Appropriateness; and

    (d) Compliance with the U.S. Food and Drug Administration and current United States Pharmacopeia approved packaging.

B. The licensed pharmacist shall ensure that labeling of the medication container includes the:

  (1) Brand or generic name of the medication;

  (2) Strength of the medication, if appropriate;

  (3) Name of the pharmacy;

  (4) Expiration date of the medication.

C. Unless the licensed pharmacist has reason to reduce the time period, the expiration date of the medication is the lesser of:

  (1) 12 months from the date of packaging;

  (2) The manufacturer's or distributor's listed expiration date; or

  (3) The maximum time period allowed for the specific packaging used for the medication.

D. Packaged from the Manufacturer’s Original Container. The pharmacy may use a lot number and expiration date assigned by the pharmacy instead of the distributor or manufacturer information in a master log if kept with respect to drugs that are packaged within the pharmacy facility from the original manufacturer’s container which includes the:

  (1) Name of the drug;

  (2) Strength;

  (3) Manufacturer;

  (4) Lot number assigned by the pharmacy;

  (5) Lot number assigned by the distributor or manufacturer;

  (6) Quantity packaged;

  (7) Expiration date as defined in §C of this regulation;

  (8) Manufacturer's expiration date;

  (9) Date of packaging;

  (10) Name of pharmacy technician packaging; and

  (11) Name and initials of verifying licensed pharmacist.

E. Packaged from Another Pharmacy. The licensed pharmacist may package patient specific medication received from another pharmacy licensed in Maryland or operated by the government of the United States provided that:

  (1) The licensed pharmacist determines that the medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the time it was dispensed by the original pharmacy and received by the packaging pharmacy;

  (2) The licensed pharmacist packages and dispenses all at one time the entire quantity of the prescription medications received from another pharmacy for packaging;

  (3) The manufacturer’s name is present on the container received from the other pharmacy; and

  (4) The licensed pharmacist maintains a master log that includes the following information:

    (a) Name of the drug;

    (b) Lot number assigned by the packaging pharmacy;

    (c) Strength;

    (d) Manufacturer;

    (e) Name, address, and telephone number of the original dispensing pharmacy;

    (f) Prescription number for the original dispensing pharmacy;

    (g) Quantity packaged;

    (h) Expiration date as assigned by the original dispensing pharmacy;

    (i) Date of packaging;

    (j) Name of pharmacy technician packaging;

    (k) Name and initials of verifying licensed pharmacist; and

    (l) Name of the patient.

#### Regulation .08 Labeling of Patient Medications.

*COMAR 10.34.23.08*

A. The director of pharmacy or designee shall ensure that medications dispensed by the pharmacy and intended for use within the comprehensive care facility are dispensed in appropriate containers and are labeled with the:

  (1) Name and address of the pharmacy;

  (2) Date of dispensing;

  (3) Prescription number assigned by the pharmacy;

  (4) Name of the patient;

  (5) Name, quantity, and strength of the drug;

  (6) Name of the prescriber;

  (7) Expiration date of the drug;

  (8) Required precautionary information regarding controlled substances; and

  (9) Further cautionary information as may be required or desirable for proper use of the medication.

B. The director of pharmacy or designee shall ensure that medication provided per dosing period in a single container, slot, blister package, any other method of delivering an entire single dosing unit, or as part of a multi-dose dispensing package is labeled with at least the following:

  (1) Drug name;

  (2) Drug strength;

  (3) Name of manufacturer;

  (4) Name of the patient;

  (5) Lot number; and

  (6) Expiration date.

C. The director of pharmacy or designee shall be responsible for the safe and efficient dispensing, delivery, control of, and accountability for medications and devices dispensed or distributed by the permit holder.

D. The director of pharmacy or designee shall work in cooperation with the other professional staff of the comprehensive care facility in meeting the responsibilities set forth in §B of the regulation and in ordering, storing, and accounting for pharmaceutical materials.

E. Compounded Sterile Preparations. When compounding sterile preparations a licensed pharmacist or a registered pharmacy technician under the licensed pharmacist’s supervision, shall comply with the compounding and labeling requirements of COMAR 10.34.19.

#### Regulation .09 Drug Control and Accountability.

*COMAR 10.34.23.09*

A. The director of pharmacy or designee shall develop a process for the pharmacy to be notified of medications which have been discontinued.

B. Medications may be accepted for return if:

  (1) The returned medication is properly labeled and properly sealed in the manufacturer’s package or an individually labeled unit dose of a drug or a device;

  (2) The licensed pharmacist determines that the returned medication has been handled in a manner which preserves the strength, quality, purity, and identity of the drug or device during an interim period between the sale of the drug or device and its return to the pharmacy; and

  (3) The permit holder otherwise complies with COMAR 10.34.10.07.

C. Discontinued Medications — Controlled Dangerous Substances.

  (1) Except as provided in §§B(2) and C(2) of this regulations, drugs classified as Schedule II, Schedule III, Schedule IV, and Schedule V may not be returned to the inventory of the pharmacy.

  (2) Schedule III, Schedule IV, and Schedule V medications may be returned to inventory of a pharmacy when the pharmacy uses a distribution system that classifies medications as pharmacy inventory until the utilization of the medication by the patient.

D. A compounded sterile preparation may not be returned to the inventory of a pharmacy.

E. Drugs requiring refrigeration may not be returned to the inventory of a pharmacy.

F. Emergency Drug Kit.

  (1) The director of pharmacy or designee shall ensure that the emergency drug kit is secured with a tamper-evident seal or electronic security system which will indicate the opening of the kit.

  (2) Labeling. The director of pharmacy or designee shall ensure that the emergency drug kit meets the following specifications:

    (a) The exterior of the emergency drug kit is labeled to indicate clearly and unmistakably that it is an emergency drug kit and that it is for use in emergencies only;

    (b) The exterior of the emergency drug kit is labeled to indicate the:

      (i) Names of the drugs contained in the emergency drug kit;

      (ii) Strengths of the drugs contained in the emergency drug kit;

      (iii) List of contents with expiration dates, with the date of the first item to expire in bold print; and

      (iv) The quantity of each drug contained in the emergency drug kit; and

    (c) Medications contained in the emergency drug kit are labeled with the:

      (i) Name of the drug;

      (ii) Strength of the drug;

      (iii) Expiration date of the drug;

      (iv) Lot number of the drug; and

      (v) Other information required by the medical staff.

  (3) Replacement of Medications.

    (a) A licensed pharmacist or licensed pharmacist's designee shall replace the emergency drug kit or replenish used or expired drugs contained in the emergency drug kit within 72 hours of notification of use or expiration.

    (b) A licensed pharmacist shall perform the final check on the contents of the emergency drug kit.

G. Interim Box.

  (1) An interim box may be provided by the pharmacy and kept at the comprehensive care facility if comprehensive care facility policies and procedures address an interim box and the pharmacy complies with these policies and procedures.

  (2) A licensed pharmacist shall perform the final check on the contents of the interim box.

H. Prescriber Orders.

  (1) A licensed pharmacist shall dispense medications from the pharmacy only upon receipt of a valid written prescription, chart order, or verbal order from an authorized prescriber.

  (2) A chart order shall be considered a prescription drug order provided that the prescription drug order contains:

    (a) The full name of the patient;

    (b) The date of issuance;

    (c) The name, strength, and dosage form of the drug prescribed;

    (d) The name, type, and specifications of any device;

    (e) The directions for use;

    (f) If written, the authorized prescriber’s signature or the signature of the authorized prescriber’s agent (including the name of the authorized prescriber);

    (g) If electronically transmitted, prescription requirements as described in COMAR 10.34.20; and

    (h) If verbal, the name of the prescriber and the prescriber’s agent, if applicable.

  (3) A written order may be received by the pharmacy by facsimile, electronic transmission, or as the original physician order.

  (4) The licensed pharmacist shall document immediately a verbal order in writing.

  (5) A licensed pharmacist may receive a verbal order:

    (a) By telephone with the licensed pharmacist reading back the prescription to the prescriber or the prescriber’s agent; or

    (b) By a voice messaging system.

I. Controlled Dangerous Substances.

  (1) Drug Accountability. The permit holder shall ensure that personnel employed by the pharmacy abide by the laws and regulations as defined in Health-General Article, Title 27, Annotated Code of Maryland, and COMAR 10.19.03.

  (2) Storage and Security. The permit holder shall establish effective procedures for storage and security of Schedule II controlled dangerous substances including limitation of access to these drugs in the pharmacy to licensed pharmacists and registered pharmacy technicians.

J. Drug Recalls. The director of pharmacy or designee shall develop and implement a recall procedure that can be readily activated to ensure that drugs which have been recalled are returned to the pharmacy, sequestered, and handled as appropriate to the level of the recall.

K. Adverse Drug Reactions.

  (1) The director of pharmacy or designee shall participate on the appropriate committee of the comprehensive care facility to establish procedures to report and record adverse drug reactions.

  (2) The director of pharmacy or designee shall ensure the procedures established include, at a minimum:

    (a) The reporting of significant adverse drug reactions to the attending prescriber or designee and other parties as specified by the committee of the comprehensive care facility; and

    (b) The recording in writing of an adverse reaction on the patient’s chart at the time it is reported.

L. Records and Reports. The director of pharmacy or designee shall maintain records and reports as may be required by law, this chapter, and the policies of the comprehensive care facility.

#### Regulation .10 Quality Management.

*COMAR 10.34.23.10*

The director of pharmacy or designee, in cooperation with the pharmaceutical services committee of the comprehensive care facility, shall be responsible for developing procedures for an ongoing quality management program that includes a mechanism for reviewing and evaluating pharmaceutical services as defined in this chapter.