reglab/statecodes huggingface dataset:
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.14 - Training of Staff, Patient, and Caregiver

Current through Register Vol. 51, No. 14, July 12, 2024
A. The health care practitioner shall make
				  counseling available to the patient or primary caregiver, or both, concerning
				  proper use of compounded sterile preparations and related supplies furnished by
				  the sterile compounding facility.
B. The permit holder shall ensure that
				  sterile compounding facility personnel engaging in compounding sterile
				  preparations are trained and demonstrate competence in the safe handling and
				  compounding of compounded sterile preparations and parenteral solutions,
				  including cytotoxic agents if applicable.
C. The permit holder shall maintain records
				  of training and demonstrated competence for individual employees for 5
				  years.
D. The permit holder shall
				  ensure the continuing competence of sterile compounding facility personnel
				  engaged in compounding sterile preparations.
E. A sterile compounding facility that
				  compounds sterile preparations shall comply with the following training
				  requirements:
(1) The sterile compounding
				  facility shall establish and follow a written program of training and
				  performance evaluation designed to ensure that individuals working in the
				  designated area have the knowledge and skills necessary to perform the assigned
				  tasks properly and include at least the following:
(a) Aseptic technique with media fill
				  verification at a frequency defined by risk level as described in USP 797
				  Standards:
(i) 12 months for low and medium
				  risk; and
(ii) 6 months for high
				  risk;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.15 - Quality Assurance

Current through Register Vol. 51, No. 14, July 12, 2024
The permit holder shall ensure that the compounded sterile
					 preparation retains its potency and sterility throughout the assigned "beyond
					 use" dating period through a written quality assurance program that
					 includes:
A. A reasonable effort by
				  the pharmacist to assure that compounded sterile preparations shall be kept
				  under appropriate controlled conditions before dispensing, during transport,
				  and at the location of use by providing adequate labeling and verbal or written
				  instructions regarding proper storage and administration, as set forth by the
				  product manufacturer and established standards and literature, with each
				  compounded sterile preparation dispensed;
B. The phases of compounded sterile
				  preparation, distribution, storage, administration, and directions for use for
				  each type of preparation dispensed;
C. Environmental sampling for microbial
				  organisms in laminar air flow workstations and clean rooms is performed
				  according to methods and schedules specified by USP 797 Standards and if
				  microbial contamination is suspected, for example, in the event of positive
				  media fill verification results;
D.
				  Laminar air flow workstations, biological safety cabinets, and compounding
				  aseptic isolators certified by a trained and qualified operator;
E. Clean room and anteroom certification by a
				  trained and qualified operator according to USP 797 Standards;
F. The proper disposal in accordance with
				  accepted professional standards and applicable State and federal laws of unused
				  drugs and materials used in the preparation of compounded sterile preparations,
				  including antineoplastic agents and hazardous materials;
G. A formal written review process to report
				  and evaluate compliance with this chapter; and
H. A process that complies with applicable
				  USP 797 Standards for performing sterility checks or pyrogen testing, or both,
				  for applicable compounded sterile preparations.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.16 - Reference Library

Current through Register Vol. 51, No. 14, July 12, 2024
Minimum reference materials in a sterile compounding
					 facility shall include:
A. U.S.
				  Pharmaceutical, General Chapter 797, Pharmaceutical Compounding-Sterile
				  Preparations and other applicable reference materials in order to perform
				  sterile compounding;
B. Reference
				  materials containing drug stability and compatibility data; and
C. Reference materials concerning drug
				  interactions and incompatibility.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.17 - Minimum Requirements for Inspections

Current through Register Vol. 51, No. 14, July 12, 2024
A. The Board shall inspect pharmacies located
				  in Maryland at least annually.
B.
				  The pharmacy shall provide as part of the inspection process:
(1) Quality assurance testing
				  reports;
(2) Documentation of
				  reporting adverse events as required in Regulation .18 of this
				  chapter;
(3) Microbial testing of a
				  sampling of the sterile compounded preparations of the pharmacy if applicable
				  according to USP 797 Standards; and
(4) Any other information requested to ensure
				  compliance with USP 797 Standards.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.18 - Reporting Requirements Pharmacies

Current through Register Vol. 51, No. 14, July 12, 2024
A pharmacy shall:
A. Document and perform routine testing as
				  required by USP 797 Standards for the appropriate risk levels of sterile
				  compounded preparations; and
B.
				  Report to the Board within 5 calendar days:
(1) Adverse events that have been discovered
				  including corrective actions taken or proposed;
(2) Deficiencies related to the sterile
				  compounding process;
(3)
				  Disciplinary actions in other states or by other state agencies;
(4) Changes in accreditation
				  status;
(5) Disciplinary actions
				  taken against a pharmacist who is an owner, operator, or employee of the
				  pharmacy; and
(6) Disciplinary
				  actions taken against any other known permit, or any other authorization, held
				  by the pharmacy permit holder.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.19 - Office Use

Current through Register Vol. 51, No. 14, July 12, 2024
Unless otherwise authorized, a person that prepares and
					 distributes sterile compounded medications for office use into, out of, or
					 within the State shall hold:
A. A
				  manufacturer's permit or other permit designated by the U.S. Food and Drug
				  Administration to ensure the safety of sterile compounded medications for
				  office use; and
B. If applicable, a
				  wholesale distributor's permit, issued by the Board under Health Occupations
				  Article, Title 12, Subtitle 6C, Annotated Code of Maryland.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.20 - Format of Prescription Transmission › Section 10.34.20.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter applies to the conveyance or transmission of
					 prescription orders from authorized prescribers to pharmacies in the
					 State.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.20 - Format of Prescription Transmission › Section 10.34.20.02 - Requirements for Prescription Validity

Current through Register Vol. 51, No. 14, July 12, 2024
A. A valid prescription shall be:
(1) Valid in the professional judgment of the
				  pharmacist responsible for filling the prescription; and
(2) Conveyed:
(a) In a manner that contains the
				  handwritten, pen-to-paper signature of the prescriber;
(b) In a manner that is transmitted to the
				  pharmacy electronically, provided that the prescription is:
(i) Transmitted via electronic intermediaries
				  that are certified by the Maryland Health Care Commission;
(ii) Received by the permit holder's
				  computer, facsimile machine, or other electronic device; and
(iii) Maintained by the permit holder in
				  accordance with Regulation .03 of this chapter; or
(c) In an oral manner where:
(i) Only a pharmacist may take an original
				  oral prescription by a voice messaging system or by phone with the pharmacist
				  reading back the prescription to the prescriber or the prescriber's agent;
				  and
(ii) The pharmacist promptly
				  reduces the oral prescription to writing.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.20 - Format of Prescription Transmission › Section 10.34.20.03 - Prescription Records

Current through Register Vol. 51, No. 14, July 12, 2024
The pharmacy permit holder shall maintain prescription
					 records in a form that:
A. Is readily
				  and accurately retrievable;
B. Is
				  maintained for at least 5 years from the date of dispensing; and
C. Protects the confidentiality and security
				  of the prescription information.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.20 - Format of Prescription Transmission › Section 10.34.20.04 - Controlled Dangerous Substances

Current through Register Vol. 51, No. 14, July 12, 2024
Transmission and dispensing of controlled dangerous
					 substances shall be in accordance with applicable State and federal statutes
					 and regulations.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.21 - Standard of Practice for Unlicensed Personnel › Section 10.34.21.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter establishes standards of practice and the
					 responsibilities of licensed pharmacists and pharmacy permit holders when using
					 unlicensed personnel in the prescription area of a pharmacy.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.21 - Standard of Practice for Unlicensed Personnel › Section 10.34.21.02 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following terms have the meanings indicated.
B. Terms Defined.
(1) "Board" means the State Board of
				  Pharmacy.
(2) "Operational support"
				  means tasks performed by:
(a) An
				  administrative clerk;
(b) A billing
				  clerk;
(c) A cashier;
(d) Delivery personnel;
(e) A file clerk;
(f) An inventory control clerk; or
(g) An individual engaged in janitorial
				  services.
(3) "Permit
				  holder" means a person or corporation or other legal entity holding a permit
				  issued by the Board to establish and operate a pharmacy.
(4) "Pharmacy" means an establishment holding
				  a permit under Health Occupations Article, §
											12-401, Annotated
				  Code of Maryland.
(5) "Prescription
				  area" means that portion of an establishment to which a pharmacy permit has
				  been issued, which contains:
(a) Prescription
				  drugs;
(b) Prescription devices;
				  and
(c) Patient records.
(6) "Supervision" means the
				  on-site provision of management, direction, oversight, and review of tasks
				  assigned to personnel.
(7)
				  "Unlicensed personnel" means individuals employed by the permit holder who
				  provide operational support in the prescription area under the supervision of a
				  licensed pharmacist.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.21 - Standard of Practice for Unlicensed Personnel › Section 10.34.21.03 - Duties of the Permit Holder

Current through Register Vol. 51, No. 14, July 12, 2024
The permit holder shall:
A. Determine which operational support tasks
				  the pharmacist may assign unlicensed personnel to perform in the prescription
				  area;
B. Ensure that unlicensed
				  personnel:
(1) Receive appropriate training
				  for the tasks that the pharmacist assigns unlicensed personnel to perform in
				  the prescription area;
(2) Receive
				  training that will enable unlicensed personnel to understand how the provisions
				  of Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland,
				  apply to:
(a) Prescription records,
				  and
(b) The requirements for
				  confidentiality of patient specific information; and
(3) When performing tasks in the prescription
				  area, maintain proper:
(a)
				  Sanitation;
(b) Hygiene;
(c) Biohazard precautions; and
(d) Infection control; and
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.21 - Standard of Practice for Unlicensed Personnel › Section 10.34.21.04 - Duties of the Pharmacist

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  pharmacist shall provide supervision to unlicensed personnel.
B. The pharmacist may not delegate any
				  pharmacy acts to unlicensed personnel.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.21 - Standard of Practice for Unlicensed Personnel › Section 10.34.21.05 - Duties of Unlicensed Personnel

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Unlicensed personnel under the supervision of a pharmacist may perform
				  operational support which the unlicensed personnel have been trained to
				  adequately perform in the prescription area.
B. Unlicensed personnel who perform duties in
				  the prescription area shall maintain the confidentiality of patient specific
				  data in accordance with Health-General Article, Title 4, Subtitle 3, Annotated
				  Code of Maryland.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.21 - Standard of Practice for Unlicensed Personnel › Section 10.34.21.06 - Grounds for Discipline

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  pharmacist licensee may be subject to discipline if the pharmacist licensee
				  violates any provision of Regulation .04 of this chapter.
B. A permit holder may be subject to
				  disciplinary action if:
(1) The permit holder
				  fails to take reasonable safeguards to ensure compliance with the regulations
				  of the Board; or
(2) The permit
				  holder otherwise violates any of the provisions of Regulation .03 of this
				  chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.22 - Licensing of Wholesale Prescription Drug or Device Distributors › Section 10.34.22.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter applies to any person engaged in the wholesale
					 distribution of prescription drugs or devices in Maryland.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.22 - Licensing of Wholesale Prescription Drug or Device Distributors › Section 10.34.22.03-1 - Minimum Application Requirements for Virtual Manufacturers

Current through Register Vol. 51, No. 14, July 12, 2024
The information and qualification requirements for
					 obtaining a permit under Regulation .03 of this chapter, beyond that required
					 by federal law, do not apply to a virtual manufacturer that meets the following
					 requirements:
A. Provides a list of
				  drug or device products it distributes;
B. Provides a list of the NDA or ANDA numbers
				  associated with each drug it distributes;
C. Provides a list of the UDI numbers, as
				  available, associated with each device it distributes;
D. Provides the name and facility address of
				  the contract manufacturer for each drug or device product it distributes;
E. Provides verification of
				  current FDA registration for each contract manufacturing facility listed;
F. If the contract manufacturer
				  distributes into this State, provides the wholesale distributor permit number
				  for the contract manufacturer;
G.
				  If the contract manufacturer does not distribute into this State, provides name
				  and Maryland's wholesale distributor permit number for the entity that
				  physically distributes the product into this State;
H. Provides a statement affirming that the
				  virtual manufacturer does not contract the manufacture or distribution for
				  drugs or devices other than those for which it owns the NDA, ANDA, or UDI
				  numbers;
I. Provides an
				  attestation by the owner of the virtual manufacturer that it does not hold
				  product;
J. Provides a copy of
				  existing licensure from the state in which it is located, if applicable; and
K. Has valid federal licensure or
				  registration, as verified by the Board.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.22 - Licensing of Wholesale Prescription Drug or Device Distributors › Section 10.34.22.04 - Personnel

Current through Register Vol. 51, No. 14, July 12, 2024
A. The permit
				  holder shall affirm in the initial application and subsequent renewal
				  applications that personnel employed in wholesale distribution have appropriate
				  education and experience to assume responsibilities related to compliance with
				  State licensing requirements.
B.
				  Registered Agent.
(1) Each licensed wholesale
				  distributor located outside of this State that wholesale distributes
				  prescription drugs or devices in this State shall designate a registered agent
				  in this State for service of process.
(2) If any wholesale distributor is not
				  licensed in this State, service on the Director of the State Department of
				  Assessments and Taxation only shall be sufficient service.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.22 - Licensing of Wholesale Prescription Drug or Device Distributors › Section 10.34.22.06 - Minimum Requirements for the Storage and Handling of Prescription Drugs or Devices

Current through Register Vol. 51, No. 14, July 12, 2024
A. Facilities.
				  Facilities at which prescription drugs or devices are stored, warehoused,
				  handled, held, offered, marketed, or displayed shall:
(1) Be of suitable size and construction to
				  facilitate:
(a) Cleaning;
(b) Maintenance; and
(c) Proper operations;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.22 - Licensing of Wholesale Prescription Drug or Device Distributors › Section 10.34.22.08 - Due Diligence

Current through Register Vol. 51, No. 14, July 12, 2024
Wholesale distributors having transactions with persons not
					 licensed by the Board or not certified by a third party recognized by the Board
					 shall have in place policies and procedures to perform due diligence on
					 transactions that take place that include:
A. Verification of alternate
				  licensure;
B. Verification of
				  identity; and
C. Verification of
				  recent inspections by a state or third party entity recognized by the
				  Board.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.22 - Licensing of Wholesale Prescription Drug or Device Distributors › Section 10.34.22.09 - Reinstatement

Current through Register Vol. 51, No. 14, July 12, 2024
A. The wholesale
				  distributor permit shall expire on the last day of its term.
B. The Board may not reinstate the wholesale
				  distributor permit unless the applicant pays a reinstatement fee set by the
				  Board
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.22 - Licensing of Wholesale Prescription Drug or Device Distributors › Section 10.34.22.10 - Required Information and Procedures for Ceasing to Operate

Current through Register Vol. 51, No. 14, July 12, 2024
A. If a wholesale
				  distributor is located in another state, a wholesale distributor anticipating
				  ceasing to operate in Maryland shall return the permit to the Board within 10
				  days of ceasing to operate in Maryland.
B. Procedures for Wholesale Distributors
				  Located in this State for Ceasing to Operate.
(1) Notification.
(a) At least 30 days before a wholesale
				  distributor's anticipated date of ceasing to operate, the wholesale distributor
				  shall notify the Board in writing, by certified mail, return receipt requested,
				  or hand delivered to the Board's office, of the day on which the wholesale
				  distributor will cease to operate.
(b) A wholesale distributor shall:
(i) Notify drug and device suppliers that
				  supply prescription drugs and devices to the wholesale distributor, at least 30
				  days in advance of ceasing to operate, of the date that the wholesale
				  distributor will cease to operate;
(ii) Notify manufacturers, wholesale
				  distributors, licensed pharmacies and authorized prescribers that receive
				  prescription drugs and devices from the wholesale distributor, at least 30 days
				  in advance of ceasing to operate, of the date that the wholesale distributor
				  will cease to operate; and
(iii)
				  Comply with applicable federal regulations.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.22 - Licensing of Wholesale Prescription Drug or Device Distributors › Section 10.34.22.11 - Relocation

Current through Register Vol. 51, No. 14, July 12, 2024
A. At least 30 days
				  before relocation, a permit holder shall submit an application to the
				  Board.
B. If relocation is due to a
				  catastrophic event or State of Emergency, the relocation applicant shall:
(1) Notify the Board within 48 hours;
				  and
(2) Submit an application to
				  the Board within 30 days.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.23 - Pharmaceutical Services to Patients in Comprehensive Care Facilities › Section 10.34.23.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.23 - Pharmaceutical Services to Patients in Comprehensive Care Facilities › Section 10.34.23.03 - Policies and Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
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;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.23 - Pharmaceutical Services to Patients in Comprehensive Care Facilities › Section 10.34.23.04 - Personnel

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.23 - Pharmaceutical Services to Patients in Comprehensive Care Facilities › Section 10.34.23.05 - Physical Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.23 - Pharmaceutical Services to Patients in Comprehensive Care Facilities › Section 10.34.23.06 - Medication and Device Distribution and Pharmaceutical Services

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.23 - Pharmaceutical Services to Patients in Comprehensive Care Facilities › Section 10.34.23.07 - Medication Packaging

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.23 - Pharmaceutical Services to Patients in Comprehensive Care Facilities › Section 10.34.23.08 - Labeling of Patient Medications

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.23 - Pharmaceutical Services to Patients in Comprehensive Care Facilities › Section 10.34.23.09 - Drug Control and Accountability

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.23 - Pharmaceutical Services to Patients in Comprehensive Care Facilities › Section 10.34.23.10 - Quality Management

Current through Register Vol. 51, No. 14, July 12, 2024
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.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.24 - Record of Drug Inventory Acquisition › Section 10.34.24.01 - Purpose

Current through Register Vol. 51, No. 14, July 12, 2024
The purpose of this chapter is to establish the minimum
					 requirements for drug acquisition records to be maintained by pharmacy permit
					 holders.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.24 - Record of Drug Inventory Acquisition › Section 10.34.24.02 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
A. This chapter
				  applies to all pharmacy permit holders in this State.
B. This chapter applies to the acquisition of
				  all prescription medication drug inventories.
C. This chapter applies to a pharmacy's
				  acquisition of drug inventory from all sources including, but not limited to,
				  pharmacies, distributors, and manufacturers, and through all means including,
				  but not limited to, purchases, barter or exchange, free goods, rebates, and
				  replacement products.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.24 - Record of Drug Inventory Acquisition › Section 10.34.24.03 - Minimum Requirements for Maintenance of Drug Acquisition Records

Current through Register Vol. 51, No. 14, July 12, 2024
A. A pharmacy
				  permit holder shall maintain records of all drug inventory
				  acquisitions.
B. The records
				  maintained shall include:
(1) The name and
				  principal address of the source of the drugs;
(2) The identity and quantity of the drugs
				  received; and
(3) The date the
				  drugs were received.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.24 - Record of Drug Inventory Acquisition › Section 10.34.24.04 - Violation and Inspection

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  pharmacy permit holder shall make the drug inventory acquisition records
				  required under this chapter available for inspection upon request by any
				  federal, state, or local law enforcement agent, or any other duly authorized
				  agent of the Board of Pharmacy or the Division of Drug Control, within 72 hours
				  of the request.
B. A pharmacy
				  permit holder shall produce and maintain the records required under this
				  chapter for drug acquisitions for all acquisitions except those replaced within
				  7 days.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.25 - Delivery of Prescriptions › Section 10.34.25.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter governs the manner in which a Maryland
					 licensed pharmacy delivers filled prescriptions for individual patients by
					 United States Postal Service, common carrier, or delivery service to an address
					 within the State.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.25 - Delivery of Prescriptions › Section 10.34.25.02 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following terms have the meaning indicated.
B. Terms Defined.
(1) "Delivery" means to send a prescription
				  medication from a pharmacy by the United States Postal Service, common carrier,
				  or delivery system to an address within the State.
(2) Depot.
(a) "Depot" means a location where filled
				  prescriptions are stored before delivery to the intended patient or the
				  intended patient's authorized agent.
(b) "Depot" does not include:
(i) A licensed health care
				  facility;
(ii) A prescriber's
				  office;
(iii) The prescription area
				  of a pharmacy as defined by COMAR
				  10.34.05.01B;
(iv) The United States Postal Service or
				  common carrier's warehouse; or
(v)
				  A multiple family residence.
(3) "Patient" means the individual or
				  companion animal for whom a prescription is written and to whom a prescription
				  medication will be administered.
(4) "Patient profile" means a record of
				  dispensing activity maintained by a pharmacist for a specific
				  patient.
(5) "Residence" means the
				  street address at which a patient resides.
(6) "Storage" means the maintenance of a
				  supply of medication before receipt of the medication by the patient or an
				  agent authorized by the patient.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.25 - Delivery of Prescriptions › Section 10.34.25.03 - Requirements for Packaging and Delivery of Prescription Medication

Current through Register Vol. 51, No. 14, July 12, 2024
A. Packaging.
				  Prescription medications delivered under this chapter to individuals in the
				  State shall be:
(1) Enclosed in a container
				  that reveals to the patient any tampering of the container that occurred during
				  delivery or storage;
(2) Packaged
				  in a shipping container in a manner that does not indicate that the contents
				  are medications;
(3) Packaged in a
				  manner that indicates:
(a) The name and
				  address of the patient or authorized agent; and
(b) Any special storage conditions or
				  requirements; and
(4)
				  Packaged to contain:
(a) Written information
				  regarding the prescription drug or device which is considered significant in
				  the professional judgment of the pharmacist;
(b) A local or toll-free telephone number for
				  the pharmacy; and
(c) Notification
				  to the patient if the appearance of the patient's medication has changed from
				  the patient's last refill.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.25 - Delivery of Prescriptions › Section 10.34.25.04 - Depots

Current through Register Vol. 51, No. 14, July 12, 2024
A pharmacy may not knowingly deliver prescription
					 medications to a depot, or establish or cooperate in the establishment of a
					 depot.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.25 - Delivery of Prescriptions › Section 10.34.25.05 - Record Keeping

Current through Register Vol. 51, No. 14, July 12, 2024
A. If a patient
				  authorizes delivery of prescription medication to an agent at a location other
				  than the pharmacy, or the patient's residence, the pharmacist shall document
				  the authorization:
(1) On the
				  prescription;
(2) In the patient
				  profile; or
(3) In another record
				  maintained in the pharmacy and established for this purpose.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.26 - Patient Safety Improvement › Section 10.34.26.01 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following terms have the meanings indicated.
B. Terms Defined.
(1) "High-alert medication" means a
				  medication with:
(a) A significant potential
				  for involvement in a mediation error due to the medication's name, packaging,
				  appearance, dosing, or other characteristics of the agent; or
(b) A high potential for causing serious harm
				  or injury if used incorrectly.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.26 - Patient Safety Improvement › Section 10.34.26.02 - Patient Education

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  pharmacy permit holder shall establish methods to provide patients with
				  information regarding the patient's role and responsibility in preventing
				  medication errors in a manner that is reasonably likely to convey the
				  information to the patient, and if applicable, the patient's health care agent
				  or surrogate decision maker, under Health-General Article, Title 5, Subtitle 6,
				  Annotated Code of Maryland, and that is in addition to any other patient
				  counseling or information required to be given by other laws and
				  regulations.
B. The information in
				  §A of this regulation shall be provided to the patient before or at the
				  time the drug or device is presented to the patient.
C. Exception. If the patient is an inpatient
				  at a health care facility, the information in §A of this regulation shall
				  be:
(1) Provided directly to a patient and,
				  if applicable, a patient's health care agent or surrogate decision maker before
				  discharge; or
(2) Available in a
				  conspicuous location on the institution's premises where the patient and, if
				  applicable, the patient's health care agent or surrogate decision maker, are
				  reasonably likely to have an opportunity to review the information.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.26 - Patient Safety Improvement › Section 10.34.26.03 - Pharmacy Staff Education

Current through Register Vol. 51, No. 14, July 12, 2024
As part of a pharmacy permit holder's ongoing quality
					 assurance program, the pharmacy permit holder shall:
A. Ensure that each member of the pharmacy
				  staff involved in the medication delivery system receive at least once a year,
				  education regarding the role and responsibility of pharmacy staff in preventing
				  medication errors; and
B. Maintain
				  records for a minimum of 2 years:
(1)
				  Verifying completion of education referred to in §A of this regulation;
				  and
(2) Demonstrating the content
				  of the education.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.26 - Patient Safety Improvement › Section 10.34.26.04 - Ongoing Quality Assurance Program

Current through Register Vol. 51, No. 14, July 12, 2024
A. A pharmacy permit holder shall establish
				  and maintain an ongoing quality assurance program to:
(1) Identify, investigate, and promote the
				  prevention of medication errors; and
(2) Establish protocols and procedures to
				  minimize the potential for medication errors.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.27 - Compelling Purpose Disclosure › Section 10.34.27.01 - Disclosure for Compelling Public Purpose

Current through Register Vol. 51, No. 14, July 12, 2024
The custodian of records may find that a compelling public
					 purpose warrants disclosure of information in a certification, licensing, or
					 investigative file, regardless of whether there has been a request for the
					 information, if the information concerns:
A. Possible criminal activity and is
				  disclosed to a federal, state, or local law enforcement or prosecutorial
				  official or authority;
B. A
				  possible violation of law and is disclosed to a federal, state, or local
				  authority that has jurisdiction over the individual whose conduct may be a
				  violation and the information disclosed is limited to information relevant to
				  the possible violation by that individual; or
C. Conduct by an individual that the
				  custodian of records reasonably believes may pose a risk to the public health,
				  safety, or welfare, and is disclosed to a law enforcement authority,
				  administrative official, or agency that regulates the individual, or to a
				  hospital or other health care facility where the individual has
				  privileges.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.27 - Compelling Purpose Disclosure › Section 10.34.27.02 - Other Disclosures

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter does not prohibit or limit the ability of the
					 Board to disclose general licensing information as provided in State Government
					 Article, §
										10-617(h),
					 Annotated Code of Maryland, or any information that the Board may otherwise
					 disclose by law.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter defines the parameters under which a permit
					 holder may allow the use of automated medication systems to facilitate the
					 dispensing and distribution of medication.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.02 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following terms have the meanings indicated.
B. Terms Defined.
(1) "Automated medication system" means a
				  centralized, decentralized, or remote robotic or computerized device and that
				  device's components designed to:
(a)
				  Distribute medications in a licensed health care facility, a related
				  institution as defined in Health-General Article, §19-301, Annotated Code
				  of Maryland, or a medical facility owned and operated by a group model health
				  maintenance organization as defined in Health-General Article, §19-713.6,
				  Annotated Code of Maryland; or
(b)
				  Prepare medications for final dispensing by a licensed pharmacist.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.03 - Limitation on Privileges to Administer

Current through Register Vol. 51, No. 14, July 12, 2024
In this chapter, "privileges to administer medication" does
					 not include privileges created by delegation from a licensed health care
					 professional to an unlicensed health care professional.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.04 - Usage Requirements for Centralized Automated Medication Systems

Current through Register Vol. 51, No. 14, July 12, 2024
A. An automated
				  medication system may only be used if:
(1)
				  Records concerning transactions or operations are maintained in accordance with
				  Regulation .11 of this chapter;
(2)
				  A responsible pharmacist has been designated by the permit holder to supervise
				  and manage the operations of the centralized automated medication system;
				  and
(3) The permit holder ensures
				  that:
(a) Patients have prompt access to
				  pharmacy services necessary for the provision of good pharmaceutical care as
				  defined in Health Occupations Article, §
												12-101, Annotated
				  Code of Maryland;
(b) The
				  centralized automated medication system maintains the integrity of the
				  information in the system and protects patient confidentiality; and
(c) The centralized automated medication
				  system is subject to a quality assurance program in accordance with Regulation
				  .10 of this chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.05 - Usage Requirements for Decentralized Automated Medication Systems

Current through Register Vol. 51, No. 14, July 12, 2024
A. A decentralized
				  automated medication system may only be used if:
(1) Records concerning transactions or
				  operations are maintained in accordance with Regulation .11 of this
				  chapter;
(2) A responsible
				  pharmacist has been designated by the permit holder to supervise and manage the
				  operations of the automated medication system;
(3) Except for starter doses, a licensed
				  pharmacist reviews each order for medication:
(a) After the order has been entered into the
				  system; and
(b) Before the system
				  permits access to the medication;
(4) The permit holder ensures that:
(a) Patients have prompt access to pharmacy
				  services necessary for the provision of good pharmaceutical care as defined in
				  Health Occupations Article, §
												12-101, Annotated
				  Code of Maryland;
(b) The
				  decentralized automated medication system maintains the integrity of the
				  information in the system and protects patient confidentiality; and
(c) The decentralized automated medication
				  system is subject to a quality assurance program in accordance with Regulation
				  .10 of this chapter; and
(5) It is designed to distribute medications
				  in a licensed health care facility, a related institution as defined in
				  Health-General Article, §19-301, Annotated Code of Maryland, or a medical
				  facility owned and operated by a group model health maintenance organization as
				  defined in Health-General Article, §19-713.6, Annotated Code of
				  Maryland.