reglab/statecodes huggingface dataset:
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.28 - Physical Plant

Current through Register Vol. 51, No. 14, July 12, 2024
A. New Center.
(1) A new center shall be designed,
				  constructed, and maintained according to applicable federal, State, and local
				  codes and regulations for building, zoning, fire, food, safety, health and
				  other related codes or ordinances, or both. The center shall also comply with
				  the requirements of the Americans with Disabilities Act of 1990,
				  42 U. S. C. §
												12101 et seq.
(2) Where possible, the center shall be
				  located at street level. If a proposed center will not be located at street
				  level, the licensee shall obtain prior approval from the Department before
				  design work proceeds.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.29 - Emergency Preparedness

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  center shall develop an emergency and disaster plan that includes policies and
				  procedures that shall be followed before, during, and after an emergency or
				  disaster, including:
(1) The safe management
				  of individuals who are receiving services at the adult medical day care center
				  when an emergency occurs;
(2)
				  Notification of families, staff and licensing authorities regarding the action
				  that will be taken concerning the safety and well-being of the
				  participants;
(3) Staff coverage,
				  organization, and assignment of responsibilities; and
(4) The continuity of operations, including
				  procedures to secure access to essential goods, equipment, and services to
				  sustain operation.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.30 - Furniture, Furnishings, and Supplies

Current through Register Vol. 51, No. 14, July 12, 2024
A. Furniture.
(1) The furniture in a center shall be:
(a) Appropriate for use by individuals with
				  disabilities;
(b) Sturdy and secure
				  so that it cannot easily tip when used for support while walking or
				  seated;
(c) Designed so that it is
				  used easily by individuals with limited agility, permitting feet to rest on the
				  floor and having armrests; and
(d)
				  Clean, safe, and in good repair.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.31 - Work Stations

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  center shall provide at least one work station for use of nurses, social
				  workers, program assistants, or other appropriate staff and
				  consultants.
B. Work stations shall
				  have sufficient storage space for records and to meet the needs of the
				  center.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.32 - Infection Control

Current through Register Vol. 51, No. 14, July 12, 2024
There shall be sufficient hand-washing facilities to ensure
					 that employees maintain adequate infection control procedures.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.33 - Food Service Area

Current through Register Vol. 51, No. 14, July 12, 2024
A Whether
				  prepared on-site or off-site, food shall:
(1)
				  Be prepared and served under sanitary conditions; and
(2) Meet the requirements of COMAR 10.15.03.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.34 - Bathrooms

Current through Register Vol. 51, No. 14, July 12, 2024
A. General
				  Requirements.
(1) Bathrooms shall be located
				  not more than 30 feet from the primary activity areas.
(2) The center shall provide at least one
				  toilet and one hand-washing sink for every 10 participants. Additional toilets
				  and hand-washing sinks may be required based upon the toileting needs of the
				  participants.
(3) Bathrooms shall
				  be accessible to individuals in compliance with the requirements of the
				  Americans with Disabilities Act of 1990.
(4) The center shall provide individual paper
				  towels, a trash receptacle, soap, and toilet paper in bathrooms at all times.
				  These supplies and equipment shall be accessible to participants at all
				  times.
(5) Space and equipment
				  shall be provided in bathrooms, to maintain privacy while cleaning or changing
				  the clothing of participants.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.35 - Laundry Facilities

Current through Register Vol. 51, No. 14, July 12, 2024
A. Laundry
				  facilities shall be available on-site for use if a participant's clothing
				  becomes soiled while he or she is at the center.
B. The area or areas where laundry facilities
				  are located shall be equipped with exhaust ventilation, secure chemical
				  storage, and dryer lint exhaust and control.
C. The center shall maintain laundry
				  facilities in a safe and sanitary manner.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.36 - Water Supply

Current through Register Vol. 51, No. 14, July 12, 2024
A. Water
				  Supply. A center shall be served by water from an approved public water supply.
				  If an approved public water supply is not available, a private water supply may
				  be used if the Department of the Environment approves the source in accordance
				  with COMAR 26.04.02.
B. Loss of
				  Water Supply. The center shall establish written emergency procedures that
				  enable the center to have water in all essential areas in the event of the loss
				  of the normal water supply.
C.
				  Adequacy of Water Pressure. The water supply shall be adequate in quantity and
				  be delivered under sufficient pressure to satisfactorily serve fixtures in the
				  center. A minimum pressure of 15 pounds per square inch shall be maintained at
				  top floor fixtures during peak demand period.
D. Water Temperature. The water heating
				  equipment shall supply adequate amounts of water as follows:
(1) Washing, bathing, and other personal use,
				  not more than 120°F or less than 100°F; and
(2) Food preparation, in conformance with
				  COMAR 10.15.03.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.37 - Plumbing and Sewage

Current through Register Vol. 51, No. 14, July 12, 2024
A. Plumbing.
				  All plumbing in a center shall be installed and maintained according to all
				  applicable federal, State, and local building codes and sanitation
				  Regulations.
B. Sewage. A center
				  shall be served by an approved public sewage disposal system, if available. If
				  no approved public sewerage system is available, a private sewage disposal
				  system may be used if the Department of the Environment approves the system
				  according to COMAR 26.04.02.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.38 - Heating, Air Conditioning, and Ventilation

Current through Register Vol. 51, No. 14, July 12, 2024
A. Heating.
(1) The center shall have a properly
				  maintained and operating central heating system that is capable of maintaining
				  75°F throughout the participants' section of the building.
(2) The heating system shall comply with NFPA
				  101, Life Safety Code, which is incorporated by reference in COMAR
				  29.06.01.06, and all applicable
				  State and local codes.
(3) A center
				  may not use space heaters or portable heaters unless approved by the State or
				  local fire authority.
(4) The
				  center shall ensure that all exposed heating pipes, hot water pipes, and
				  radiators are covered or protected to prevent exposure to participants, staff,
				  and visitors.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.39 - Lighting

Current through Register Vol. 51, No. 14, July 12, 2024
A. The center shall
				  ensure that lighting levels in all areas are appropriate for the type of
				  activity.
B. Glare from windows
				  exposed to direct sunlight shall be kept at a minimum by using window coverings
				  and glare from lights shall be kept at a minimum by using shaded light
				  fixtures.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.40 - Sanitation

Current through Register Vol. 51, No. 14, July 12, 2024
A. The center shall
				  have sufficient maintenance and housekeeping personnel to assure that the
				  center is clean, orderly, attractive, and safe at all times.
B. The center shall ensure that maintenance
				  and housekeeping activities are completed on a regular basis and according to
				  generally accepted sanitation standards. Maintenance and housekeeping functions
				  may not interfere with the provision of care or the activities program of the
				  center.
C. The center shall develop
				  and implement a written plan for preventive maintenance and repair of the
				  center.
D. Insects and Rodents.
(1) The center shall:
(a) Be maintained free of insects and
				  rodents;
(b) Maintain control
				  measures to prevent infestation by insects and vermin; and
(c) Ensure that all control measures are
				  conducted using approved methods.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.41 - Safety

Current through Register Vol. 51, No. 14, July 12, 2024
A. Fire Safety. The
				  center shall comply with the provisions of:
(1) COMAR 20.06.01;
(2) NFPA 101 Life Safety Code, which is
				  incorporated by reference in COMAR
				  29.06.01.06; and
(3) All other applicable federal, State, and
				  local fire codes and Regulations.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.42 - Smoking

Current through Register Vol. 51, No. 14, July 12, 2024
A. The center shall
				  prohibit smoking in all indoor areas in accordance with COMAR
				  09.12.23.
B. If smoking is
				  permitted in exterior areas, the center shall establish and implement smoking
				  policies and procedures that minimize the risk of fire.
C. The smoking policies and procedures shall
				  include at least the following provisions:
(1) The center shall prohibit smoking in any
				  hazardous location where flammable liquids, combustible gases, or oxygen are
				  stored;
(2) The center shall
				  designate smoking areas with ashtrays of noncombustible material and safe
				  design;
(3) Participants shall be
				  supervised at all times while smoking; and
(4) If the center has an exterior designated
				  smoking area, this area may not be located at the front entrance.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.43 - Sanctions

Current through Register Vol. 51, No. 14, July 12, 2024
A. If the
				  Department determines that a deficiency or deficiencies exist, the Secretary
				  may impose sanctions against the licensee.
B. The Secretary may impose the following
				  sanctions, as appropriate:
(1) Direct the
				  licensee to correct the deficiencies in a specific manner or within a specific
				  time frame, or both;
(2) Require
				  the center to use the services of a management firm that is approved by the
				  Department;
(3) Mandate staffing
				  patterns that specify the number of personnel or personnel qualifications, or
				  both;
(4) Appoint a State monitor,
				  as described in Regulation .44 of this chapter;
(5) Restrict the number of participants that
				  a center may admit;
(6) Impose a
				  civil money penalty;
(7) Impose
				  emergency suspension of license; and
(8) Deny or revoke a license.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.44 - State Monitor

Current through Register Vol. 51, No. 14, July 12, 2024
A. If the
				  Department determines that a deficiency or deficiencies exist, the Department
				  may appoint a State monitor who is qualified on the basis of education and
				  experience to oversee correction of the deficiencies.
B. The duties of the State monitor shall be
				  specified in a written agreement between the Department and the State monitor
				  and shall include, but are not limited to:
(1) Conducting periodic on-site inspections
				  to assess the center's compliance with regulations of this chapter;
(2) Making recommendations to achieve
				  compliance with State regulations; and
(3) Issuing written reports to the Department
				  and the center detailing the findings of the on-site inspections and the status
				  of recommended actions that the center shall complete to achieve
				  compliance.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.45 - Mandated Staffing Pattern

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  When the Department determines that a deficiency or deficiencies exist, the
				  Department shall notify the center of the deficiency or deficiencies and may
				  either:
(1) Mandate a staffing pattern that
				  specifies the number of personnel or personnel qualifications, or both;
				  or
(2) Permit the center the
				  opportunity to correct the deficiencies by a specific date.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.46 - Admission Restriction

Current through Register Vol. 51, No. 14, July 12, 2024
A. If the
				  Secretary determines that a serious health or fire safety deficiency exists in
				  a center, the Secretary immediately may restrict new admissions to the center
				  for not more than a 30-day period.
B. Within 7 days after a request by an
				  aggrieved party, a show cause hearing shall be held before the Director of the
				  Office of Health Care Quality to show cause why the admission restriction was
				  not appropriately imposed.
C.
				  Within 21 days after admissions are restricted, the center shall take steps to
				  correct the deficiency.
D. Unless
				  the Secretary lifts the admissions restriction, within 30 days after admissions
				  are restricted, a hearing shall be held to determine whether the center has
				  taken sufficient measures to correct the deficiency.
E. If the Secretary finds that the deficiency
				  still exists, the Secretary may:
(1) Continue
				  to restrict admissions for not more than three consecutive 30-day periods;
				  or
(2) Revoke the license of the
				  center.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.47 - Civil Money Penalties

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  Secretary may impose a civil money penalty if a deficiency or an ongoing
				  pattern of deficiencies exists in a center.
B. In determining whether a civil money
				  penalty is to be imposed, the Secretary shall consider the following factors:
(1) The number, nature, and seriousness of
				  the deficiencies;
(2) The extent to
				  which the deficiency or deficiencies are part of an ongoing pattern during the
				  preceding 24 months;
(3) The degree
				  of risk to the health, life, or safety of the participants of the center that
				  is caused by the deficiency or deficiencies;
(4) The efforts made by, and the ability of,
				  the center to correct the deficiency or deficiencies; and
(5) A center's prior history of
				  compliance.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.48 - Amount of Civil Money Penalties

Current through Register Vol. 51, No. 14, July 12, 2024
A. A civil money penalty imposed under this
				  chapter for potential for more than minimal harm deficiencies may not exceed:
(1) $3,000 per instance; or
(2) $300 per day for an ongoing pattern of
				  deficiencies until the center is in compliance.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.49 - Civil Money Penalties-Hearings

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  A hearing on the appeal shall be held in accordance with the State Government
				  Article, Title 10, Subtitle 2, Annotated Code of Maryland.
B. The Secretary shall have the burden of
				  proof with respect to the imposition of the civil money penalties under this
				  chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.50 - Civil Penalties-Unlicensed Center

Current through Register Vol. 51, No. 14, July 12, 2024
A. Imposition of Penalty. The Secretary may
				  impose a civil money penalty on a person who manages or operates an unlicensed
				  center as follows:
(1) A civil money penalty
				  imposed on a person under this chapter may not exceed $10,000 for each offense;
				  and
(2) When a civil money penalty
				  is imposed, the Secretary shall issue an order which includes the:
(a) Deficiency or deficiencies on which the
				  order is based;
(b) Amount of civil
				  money penalty to be imposed; and
(c) Manner in which the amount of civil money
				  penalty was calculated.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.51 - Emergency Suspension

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  Secretary may immediately suspend a license on finding that the public health,
				  safety, or welfare imperatively requires emergency action.
B. The Department shall deliver a written
				  notice to the center:
(1) Informing it of the
				  emergency suspension;
(2) Giving
				  the reasons for the action and the regulation or regulations with which the
				  licensee has failed to comply that forms the basis for the emergency
				  suspension; and
(3) Notifying the
				  center of its right to request a hearing and to be represented by
				  counsel.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.52 - Denial or Revocation of License

Current through Register Vol. 51, No. 14, July 12, 2024
A. Denial or Revocation of License. The
				  Secretary, for cause shown, shall notify the center of its decision to deny or
				  revoke the center's license. The denial or revocation shall be stayed if a
				  hearing is requested.
B. The
				  Department shall notify the center in writing of the following:
(1) The effective date of the denial or
				  revocation;
(2) The reason for the
				  denial or revocation;
(3) The
				  regulations with which the licensee has failed to comply that form the basis
				  for the denial or revocation;
(4)
				  That the center is entitled to a hearing if requested, and to be represented by
				  counsel;
(5) That the center shall
				  stop providing services on the effective date of the denial or revocation if
				  the center does not request a hearing;
(6) That the denial or revocation shall be
				  stayed if a hearing is requested; and
(7) That the center is required to surrender
				  its license to the Department if the denial or revocation is upheld.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.04 - Day Care for the Elderly and Adults with a Medical Disability › Section 10.12.04.53 - Hearings

Current through Register Vol. 51, No. 14, July 12, 2024
A. A request for a
				  hearing shall be filed with the Office of Administrative Hearings, with a copy
				  to the Office of Health Care Quality of the Department, not later than 30 days
				  after receipt of notice of the Secretary's action. The request shall include a
				  copy of the Secretary's action.
B.
				  A hearing requested under this chapter shall be conducted in accordance with:
(1) State Government Article, Title 10,
				  Subtitle 2, Annotated Code of Maryland;
(2) COMAR 28.02.01; and
(3) COMAR 10.01.03.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.05 - Breast Implantation › Section 10.12.05.01 - 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) "Breast implantation" means both:
(a) Breast augmentation, the procedure of
				  surgically inserting breast implants beneath a woman's natural breasts;
				  and
(b) The type of breast
				  reconstruction that involves surgically inserting a breast implant in the chest
				  area of a woman who has had a mastectomy.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.05 - Breast Implantation › Section 10.12.05.02 - Requirements for the Department of Health and Mental Hygiene

Current through Register Vol. 51, No. 14, July 12, 2024
The Department shall:
A. Provide a standardized written summary in
				  layperson's language that:
(1) Contains the
				  information on breast implantation generally contained in the package inserts
				  for breast implants, and
(2)
				  Discloses side effects, warnings, and cautions for a breast implantation
				  operation;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 12 - ADULT HEALTH › Chapter 10.12.05 - Breast Implantation › Section 10.12.05.03 - Requirements for Physicians

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  standardized written summary provided by the Department shall be provided to
				  the woman by the physician as soon as possible but not later than 5 days before
				  a physician performs a breast implantation operation.
B. The physician may provide the standardized
				  written summary less than 5 days before performing breast reconstruction with
				  breast implants only when the following conditions have been met:
(1) The woman's breast cancer surgery is
				  scheduled to take place within 5 days of the time she initially consults with a
				  breast cancer surgeon;
(2) The
				  woman decides to have breast implant reconstruction at the same time as the
				  breast cancer surgery;
(3) At the
				  time of the woman's initial visit with the physician who will perform the
				  breast implant reconstruction, that physician:
(a) Gives the woman the Department's
				  standardized written summary;
(b)
				  Has the patient sign the statement provided by the Department acknowledging
				  receipt of the summary; and
(c)
				  Informs the woman of the relative advantages and disadvantages of having breast
				  implant reconstruction at the same time as cancer treatment;
(4) The woman decides to waive the
				  5-day minimum waiting period and signs the waiver provided by the Department;
				  and
(5) A copy of this signed
				  waiver, along with a copy of the signed acknowledgment of receipt form, is
				  placed in the patient's medical record which is used by the
				  physician.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.01 - Dispensing of Prescription Drugs by a Licensee › Section 10.13.01.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter defines the parameters under which a licensee
					 may dispense prescription drugs in accordance with Health Occupations Article,
					 §
										12-102, Annotated
					 Code of Maryland.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.01 - Dispensing of Prescription Drugs by a Licensee › Section 10.13.01.02 - 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 Board of Dental
				  Examiners, the Board of Physicians, or the Board of Podiatric Medical
				  Examiners.
(2) Final Check.
(a) "Final check" means the verification of
				  the accuracy and completeness of a filled prescription order by the permit
				  holder before the drug is dispensed to the patient.
(b) "Final check" includes the assumption of
				  responsibility for the filled prescription, including verifying the:
(i) Appropriateness of the dose;
(ii) Accurate expiration date;
(iii) Accuracy of the drug dispensed;
(iv) Strength of the drug
				  dispensed;
(v) Labeling that
				  complies with Health Occupations Article, §
													12-505, Annotated
				  Code of Maryland; and
(vi)
				  Appropriateness of the container in which the drug is dispensed, including
				  child-proof containers where applicable.
(3) "Licensee" means the dentist, physician,
				  or podiatrist who is licensed by the appropriate Board to practice in
				  Maryland.
(4) "Personally preparing
				  and dispensing" means the licensed dentist, physician, or podiatrist:
(a) Is physically present on the premises
				  where the prescription is filled; and
(b) Performs a final check of the
				  prescription before it is dispensed to the patient
(5) "Public interest" means the dispensing of
				  prescription drugs by a licensee to a patient when a pharmacy is not
				  conveniently available to the patient.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.01 - Dispensing of Prescription Drugs by a Licensee › Section 10.13.01.03 - Application for Dispensing Permit

Current through Register Vol. 51, No. 14, July 12, 2024
A. The licensee shall complete an application
				  on a form approved by the appropriate Board and pay a fee in accordance with
				  the fee schedule for:
(1)Physicians at COMAR
				  10.32.01.12;
(2) Podiatrists at COMAR 10.40.03;
				  or
(3) Dentists at COMAR
				  10.44.20.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.01 - Dispensing of Prescription Drugs by a Licensee › Section 10.13.01.04 - Dispensing Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  licensee shall submit an application to the appropriate Board on the form that
				  the Board requires.
B. A licensee
				  may not dispense prescription drugs until a written permit is received from the
				  appropriate Board, except that a written permit is not required in order to
				  dispense starter dosages or samples provided without charge.
C. A licensee shall personally prepare and
				  dispense prescription drugs.
D.
				  Except as provided in Health Occupations Article, §
										12-102(c)(2)
				  (iii), Annotated Code of Maryland, and §S of this regulation, a licensee
				  shall dispense prescription drugs only to the patients of the
				  licensee.
E. A licensee shall comply with the labeling
				  requirements set forth in Health Occupations Article, §
										12-505, Annotated
				  Code of Maryland.
F. A licensee
				  shall comply with the child resistant packaging requirements set forth in
				  Health-General Article, Title 22, Subtitle 3, Annotated Code of
				  Maryland
G. A licensee shall comply
				  with drug recalls.
H. A licensee
				  shall record the dispensing of the prescription drug on the patient's
				  chart.
I. A licensee may not have a
				  substantial financial interest in a pharmacy.
J. A licensee shall, except for starter
				  dosages or samples provided without charge, provide the patient with a written
				  prescription.
K. A licensee shall
				  maintain for at least 5 years:
(1) A separate
				  file for Schedule II prescriptions; and
(2) Another file for other prescriptions.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.01 - Dispensing of Prescription Drugs by a Licensee › Section 10.13.01.05 - Inspection Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  Board of Dental Examiners, the Board of Physicians, and the Board of Podiatric
				  Medical Examiners shall report annually to the Office of Controlled Substances
				  Administration the names and addresses of its licensees who:
(1) Are authorized to personally prepare and
				  dispense prescription drugs; and
(2) Have reported to the appropriate Board
				  that they have personally prepared and dispensed prescription drugs within the
				  previous year.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.01 - Dispensing of Prescription Drugs by a Licensee › Section 10.13.01.06 - Failure to Comply with Dispensing Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A licensee who fails to comply with the requirements
					 governing dispensing of prescription drugs shall have the dispensing permit
					 revoked and be subject to disciplinary action by the appropriate licensing
					 board.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.02 - Purchase and Distribution of Prescription Drugs and Devices › Section 10.13.02.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter applies to the purchasing and distribution of
					 prescription drugs and devices by the Department for public health
					 purposes.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.02 - Purchase and Distribution of Prescription Drugs and Devices › Section 10.13.02.02 - 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) "Adulterated" means a drug or device
				  where:
(a) Any part of the drug or device is
				  filthy, putrid, or a decomposed substance; or
(b) The drug or device was produced,
				  prepared, packed, or held under unsanitary conditions that reasonably would be
				  expected to have:
(i) Contaminated the drug or
				  device with filth; or
(ii) Caused
				  the drug or device to be injurious to health.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.02 - Purchase and Distribution of Prescription Drugs and Devices › Section 10.13.02.03 - Personnel

Current through Register Vol. 51, No. 14, July 12, 2024
A. The Secretary
				  shall designate one or more Department employee representatives to be
				  responsible for the purchase and distribution of prescription drugs and devices
				  for public health purposes.
B. A
				  designated Department representative shall:
(1) Be a merit or contractual employee of the
				  Department employed full time in a managerial level position;
(2) Be aware of and knowledgeable about the
				  policies and procedures pertaining to the purchase and distribution of
				  prescription drugs and devices for public health purposes, including applicable
				  State and federal laws;
(3) Be
				  actively involved in, and aware of, the daily operation of the Department's
				  purchasing and distribution of prescription drugs and prescription
				  devices;
(4) Be responsible for:
(a) Storage and handling as set forth in
				  Regulation .04 of this chapter;
(b)
				  Record-keeping requirements as set forth in Regulation .06 of this chapter;
				  and
(c) Making records available
				  for inspection; and
(5)
				  Meet the following qualifications:
(a) Is 21
				  years old or older;
(b) Except for
				  an authorized absence such as sick leave or vacation leave, is physically
				  present at the Department during regular business hours;
(c) Does not have any convictions for a
				  violation of any federal, State, or local laws relating to wholesale or retail
				  prescription drug distribution or distribution of controlled substances;
				  and
(d) Does not have any
				  convictions for a felony under federal, State, or local laws.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.02 - Purchase and Distribution of Prescription Drugs and Devices › Section 10.13.02.04 - Storage and Handling

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Storage Facility. A designated Department representative shall store, hold, or
				  handle prescription drugs and devices in a facility that:
(1) Is constructed to facilitate:
(a) Cleaning; and
(b) Maintenance;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.02 - Purchase and Distribution of Prescription Drugs and Devices › Section 10.13.02.05 - Quarantine, Destruction, and Return of Prescription Drugs and Devices

Current through Register Vol. 51, No. 14, July 12, 2024
A. A designated
				  Department representative shall quarantine and physically separate prescription
				  drugs and devices that are outdated, damaged, deteriorated, misbranded, or
				  adulterated from other prescription drugs and devices until the quarantined and
				  separated prescription drugs and devices are destroyed or returned to their
				  supplier for disposal.
B. A
				  designated Department representative shall identify, mark, quarantine, and
				  physically separate from other prescription drugs and devices those
				  prescription drugs and devices whose immediate or sealed outer or sealed
				  secondary containers have been opened or used, until the prescription drugs and
				  devices are either destroyed or returned to their supplier for
				  disposal.
C. Prescription Drugs.
(1) If the conditions under which a
				  prescription drug has been returned by a local health department or a health
				  care provider cast doubt on the prescription drug's safety, identity, strength,
				  quality, or purity, then a designated Department representative shall destroy
				  the prescription drug or return the prescription drug to the supplier, unless
				  examination, testing, or other investigation proves that the prescription drug
				  meets appropriate standards of safety, identity, strength, quality, and
				  purity.
(2) In determining whether
				  the conditions under which a prescription drug has been returned by a local
				  health department or a health care provider cast doubt on the prescription
				  drug's safety, identity, strength, quality, or purity, a designated Department
				  representative shall consider, at a minimum, the:
(a) Conditions under which the prescription
				  drug has been held, stored, or shipped before or during the return of the
				  prescription drug; and
(b)
				  Condition of the prescription drug and its container, carton, or labeling, as a
				  result of storage or shipping.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.02 - Purchase and Distribution of Prescription Drugs and Devices › Section 10.13.02.06 - Record Keeping

Current through Register Vol. 51, No. 14, July 12, 2024
A designated Department representative shall:
A. Establish and maintain inventories and
				  records of transactions regarding the receipt and distribution or other
				  disposition of prescription drugs and devices;
B. Include the following information in the
				  records required under §A of this regulation:
(1) The source of a prescription drug or
				  device, including the:
(a) Name and principal
				  address of the seller or transferor; and
(b) Address of the location from which a
				  prescription drug or device was shipped;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.03 - Guidelines for Co-Prescribing Opioid Overdose Reversal Drugs › Section 10.13.03.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter applies to all licensed health care
					 practitioners who may prescribe an opioid overdose reversal drug to an
					 individual who:
A. May be at an
				  elevated risk of experiencing an opioid overdose including, but not limited to,
				  an individual who:
(1) Is receiving an opioid
				  for chronic pain;
(2) Is receiving
				  an opioid and a prescription for a benzodiazepine; or
(3) Has an opioid use disorder; or
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.03 - Guidelines for Co-Prescribing Opioid Overdose Reversal Drugs › Section 10.13.03.02 - 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) "Co-prescribed" means, with respect to an
				  opioid overdose reversal drug, the practice of prescribing the drug in
				  conjunction with an opioid prescription for a patient at an elevated risk of
				  overdose.
(2) "Department" means
				  the Maryland Department of Health.
(3) "Monitored prescription drug" means a
				  prescription drug that contains a Schedule II, Schedule III, Schedule IV, or
				  Schedule V controlled dangerous substance designated under Criminal law
				  Article, Title 5, Subtitle 4, Annotated Code of Maryland.
(4) "Opioid overdose reversal drug" means a
				  drug that:
(a) Rapidly reverses the
				  respiratory depressant effects of an opioid medication; and
(b) Is approved by the federal Food and Drug
				  Administration for the treatment of a known or suspected opioid
				  overdose.
(5)
				  "Prescribing licensed health care provider" means an individual who is
				  authorized by law to prescribe a monitored prescription drug.
(6) "Riskfactor" means a characteristic,
				  condition, behavior, or any variable that increases the likelihood of
				  developing a disease or injury.
(7)
				  "Secretary" means the Secretary of the Maryland Department of Health.
(8) Targeted Patient Population.
(a) "Targeted patient population" means an
				  individual likely to experience or witness an opioid overdose.
(b) "Targeted patient population" includes,
				  but is not limited to, an individual who:
(i)
				  Is being prescribed opioids for acute, if appropriate, or chronic
				  pain;
(ii) Is being treated for an
				  opioid use disorder;
(iii) Is
				  receiving a prescription for an opioid and a benzodiazepine; or
(iv) Resides or spends time with an
				  individual who is prescribed opioids, misuses opioids, or has an opioid use
				  disorder.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.03 - Guidelines for Co-Prescribing Opioid Overdose Reversal Drugs › Section 10.13.03.03 - General Provisions

Current through Register Vol. 51, No. 14, July 12, 2024
A. When
				  determined appropriate by the prescribing licensed health care provider,
				  targeted patient populations may be co-prescribed an opioid overdose reversal
				  drug, if the individual is at an elevated risk of experiencing an opioid
				  overdose by virtue of belonging to one or more categories of the targeted
				  patient population.
B.
				  Responsibilities of the Prescribing licensed Health Care Provider.
(1) Risk Monitoring.
(a) It is suggested that the licensed health
				  care provider routinely assess patients for their risk of being likely to
				  experience or witness an opioid overdose.
(b) The prescriber may utilize additional
				  sources of information for determining a patient's opioid overdose risk
				  including, but not limited to:
(i) Checking
				  the Maryland Prescription Drug Monitoring Program;
(ii) Reviewing medical records; and
(iii) Soliciting family input, if
				  appropriate.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.03 - Guidelines for Co-Prescribing Opioid Overdose Reversal Drugs › Section 10.13.03.04 - Additional Guidelines

Current through Register Vol. 51, No. 14, July 12, 2024
The Secretary may make the following additional clinical
					 guidance available on the Department's website:
A. Any available opioid overdose reversal
				  drug formulations, corresponding prescribing templates, and any standing order
				  for these drugs; and
B. Any other
				  applicable information deemed necessary by the Secretary.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.04 - Emergency Use Auto-Injectable Epinephrine Program › Section 10.13.04.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter applies to employees of food service,
					 recreation, or wellness facilities on the premises of an institution of higher
					 education as defined in Education Article, §
										10-101, Annotated Code of
					 Maryland, and employees of food service facilities, as defined in COMAR
					 10.15.03, who voluntarily participate in the Program.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.04 - Emergency Use Auto-Injectable Epinephrine Program › Section 10.13.04.02 - 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) "Affiliated individual" means an
				  individual who is 18 years old or older who has been designated in writing by a
				  participating facility to serve either as a health supervisor or as a
				  certificate holder.
(2) "Agent"
				  means an individual who:
(a) Is 18 years old
				  or older;
(b) Has successfully
				  completed, at the expense of the participating facility, an emergency
				  epinephrine educational training program approved by the Department;
				  and
(c) Is designated in writing by
				  a certificate holder to administer auto-injectable epinephrine in an emergency
				  situation.
(3)
				  "Anaphylaxis" means a sudden, severe, and potentially life-threatening allergic
				  reaction that occurs when an individual is exposed to an allergen.
(4) "Applicant" means an individual applying
				  for a Certificate for Emergency Epinephrine.
(5) "Auto-injectable epinephrine" means a
				  portable, disposable drug delivery device that contains a premeasured single
				  dose of epinephrine that is used to treat anaphylaxis in an emergency
				  situation.
(6) "Certificate for
				  emergency epinephrine" means a certificate issued by the Maryland Department of
				  Health to an individual employed or designated by a participating facility to
				  obtain, store, and administer auto-injectable epinephrine.
(7) "Certificate holder" means an individual
				  who is authorized by the Maryland Department of Health to obtain, store, and
				  administer auto-injectable epinephrine to be used in an emergency
				  situation.
(8) "Department" means
				  the Maryland Department of Health.
(9) "Eligible institution" means an
				  institution of higher education that has a food service facility or a
				  recreation and wellness facility on the premises and that otherwise meets the
				  requirements of this chapter.
(10)
				  "Food service facility" has the meaning stated in COMAR 10.15.03.
(11) "Health supervisor" means an individual
				  who:
(a) Provides health services for a
				  participating facility; and
(b) Is
				  licensed by the State as a:
(i)
				  Physician;
(ii) Certified nurse
				  practitioner; or
(iii) Registered
				  nurse.
(12)
				  "Participating facility" means a recreation or wellness facility at an eligible
				  institution or a food service facility, including a food service facility at an
				  eligible institution, in the State that voluntarily participates in the
				  Program.
(13) "Successfully
				  completed" means to pass a written examination with a grade of 75 percent or
				  higher.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.04 - Emergency Use Auto-Injectable Epinephrine Program › Section 10.13.04.03 - Emergency Epinephrine

Current through Register Vol. 51, No. 14, July 12, 2024
A. An
				  individual may apply, on a form prescribed by the Department, for a certificate
				  for emergency epinephrine, which shall be valid for up to 1 year if the
				  applicant:
(1) Is employed by a participating
				  facility;
(2) Is 18 years old or
				  older; and
(3) Has successfully
				  completed, at the expense of the participating facility, an emergency
				  epinephrine educational training program approved by the
				  Department.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.05 - AIDS Education Program for Persons Convicted of Drug/Sex-Related Crimes (Repealed) › Section 10.13.05.01 - Scope (Repealed)

Current through Register Vol. 51, No. 14, July 12, 2024
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.05 - AIDS Education Program for Persons Convicted of Drug/Sex-Related Crimes (Repealed) › Section 10.13.05.02 - Definitions (Repealed)

Current through Register Vol. 51, No. 14, July 12, 2024
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 3 › Subtitle 13 - DRUGS › Chapter 10.13.05 - AIDS Education Program for Persons Convicted of Drug/Sex-Related Crimes (Repealed) › Section 10.13.05.03 - Responsibilities of the Department (Repealed)

Current through Register Vol. 51, No. 14, July 12, 2024