reglab/statecodes huggingface dataset:
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.34 - Pharmacy Technicians › Section 10.34.34.07 - Standards for Pharmacy Technician Training Programs

Current through Register Vol. 51, No. 14, July 12, 2024
A. Minimum
				  Standards.
(1) Pharmacy technician training
				  programs shall, at a minimum, cover the following areas of pharmacy practice:
(a) Roles and responsibilities of the
				  pharmacy technician;
(b) Knowledge
				  of prescription medications;
(c)
				  Knowledge of strengths or dose, dosage forms, physical appearance, routes of
				  administration, and duration of drug therapy;
(d) The dispensing process;
(e) Pharmaceutical calculations;
(f) Interacting with patients;
(g) Third party prescriptions;
(h) Extemporaneous compounding;
(i) Requirements and professional standards
				  for:
(i) Preparing;
(ii) Labeling;
(iii) Dispensing;
(iv) Storing;
(v) Prepackaging;
(vi) Distributing; and
(vii) How medications are
				  administered;
(j)
				  Confidentiality;
(k) Drugs used to
				  treat the following indications:
(i)
				  Hypertension;
(ii)
				  Antihyperlipidemia;
(iii) Diabetes
				  mellitus;
(iv) Arthritis;
(v) Gastrointestinal disorders;
(vi) Asthma and allergy;
				  and
(vii) Infectious
				  diseases;
(l) Federal
				  and State laws and regulations governing the practice of pharmacy; and
(m) Knowledge of special dosing
				  considerations for pediatric and geriatric populations.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.34 - Pharmacy Technicians › Section 10.34.34.08 - Standards for Examination Approval

Current through Register Vol. 51, No. 14, July 12, 2024
The Board shall approve examinations which have:
A. Content criteria set forth in Regulation
				  .06 of this chapter;
B. A minimum
				  of 100 multiple choice questions;
C. Sufficient additional questions so that
				  the examination questions may be rotated twice a year; and
D. A passing score of 75 percent or higher.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.34 - Pharmacy Technicians › Section 10.34.34.09 - Renewal Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. The pharmacy
				  technician's registration shall expire on the last day of the birth month
				  following 1 year after initial registration.
B. Following initial registration, a pharmacy
				  technician's registration:
(1) Expires on the
				  date set by the Board unless it is renewed for an additional term;
				  and
(2) May not be renewed for a
				  term longer than 2 years.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.34 - Pharmacy Technicians › Section 10.34.34.10 - Continuing Education

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Requirements.
(1) A pharmacy technician
				  registered to practice in Maryland shall earn 20 hours of approved continuing
				  pharmaceutical education within the 2-year period immediately preceding the
				  registrant's renewal application.
(2) For the first renewal period during which
				  continuing education is mandatory for a pharmacy technician, the Board of
				  Pharmacy shall require only 10 hours of continuing education requirements.
(3) A pharmacy technician shall:
(a) Attest to the fact that the pharmacy
				  technician has completed the continuing pharmacy technician education
				  requirement on the required form; and
(b) Retain supporting documents for
				  inspection by the Board for 4 years after the date of renewal for which the
				  continuing education credits were used.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.34 - Pharmacy Technicians › Section 10.34.34.11 - Reinstatement

Current through Register Vol. 51, No. 14, July 12, 2024
A. A pharmacy
				  technician whose Maryland registration expired less than 2 years before
				  applying for reinstatement shall:
(1)
				  Complete 20 hours of continuing education; and
(2) Pay to the Board the reinstatement fee
				  established by the Board in COMAR 10.34.09.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.34 - Pharmacy Technicians › Section 10.34.34.12 - Reciprocity

Current through Register Vol. 51, No. 14, July 12, 2024
A. An
				  individual applying to register as a pharmacy technician by reciprocity shall:
(1) Submit to the Board an application on a
				  form approved by the Board;
(2)
				  Pay to the Board the fee set forth in COMAR 10.34.09; and
(3) Submit a request for a State Criminal
				  History Records check.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.35 - Infusion Pharmacy Services in an Alternate Site Care Environment › Section 10.34.35.02 - Permit Holder Responsibilities

Current through Register Vol. 51, No. 14, July 12, 2024
The permit holder shall:
A. Develop and maintain a policy and
				  procedure manual which establishes the pharmacy's policies and standard
				  operating procedures related to the provision of infusion therapy
				  services;
B. Ensure that an annual
				  review of the policy and procedure manual is performed by a qualified clinician
				  or clinicians to assure that the policies and procedures meet the current
				  standards of practice and regulatory requirements;
C. Ensure that there is a process to verify
				  the name, address, and contact information of the licensed authorized
				  prescriber of record before initiation of therapy;
D. Establish and maintain a training program
				  which includes, but is not limited to, the requirements set forth in Regulation
				  .07 of this chapter;
E. If the
				  infusion pharmacy is performing sterile compounding, ensure compliance with
				  COMAR 10.34.19;
F. If the infusion
				  pharmacy outsources sterile compounding to another pharmacy, confirm that the
				  secondary pharmacy is appropriately licensed and in compliance with COMAR
				  10.34.04 and COMAR 10.34.19;
G.
				  Assign a supervising pharmacist to provide oversight of the facility and
				  operations as specified in Regulation .03 of this chapter;
H. Ensure adequate supervision to unlicensed
				  personnel;
I. Limit access to the
				  infusion pharmacy area to authorized personnel;
J. Secure the facility and patient records in
				  compliance with federal and State laws and regulations; and
K. Develop and implement a written
				  performance improvement program as set forth in Regulation .08 of this
				  chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.35 - Infusion Pharmacy Services in an Alternate Site Care Environment › Section 10.34.35.03 - Supervising Pharmacist Responsibilities

Current through Register Vol. 51, No. 14, July 12, 2024
The supervising pharmacist or the supervising pharmacist's
					 designee shall ensure compliance with:
A. State and federal regulations;
B. Infusion pharmacy practice standards:
(1) As set forth in this chapter;
				  and
(2) As established by
				  nationally recognized professional organizations and accrediting bodies as
				  appropriate;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.35 - Infusion Pharmacy Services in an Alternate Site Care Environment › Section 10.34.35.04 - Pharmacist Responsibilities

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  pharmacist in an infusion pharmacy shall adhere to the policies and procedures
				  set forth in Regulation .06 of this chapter.
B. A pharmacist shall:
(1) Provide infusion therapy services in
				  accordance with:
(a) Orders issued by a
				  licensed authorized prescriber of record; and
(b) Where applicable, protocols issued by a
				  licensed authorized prescriber of record.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.35 - Infusion Pharmacy Services in an Alternate Site Care Environment › Section 10.34.35.05 - Support Personnel

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Pharmacy Technicians.
(1) A pharmacist working
				  in an infusion pharmacy may delegate pharmacy acts to a pharmacy technician in
				  accordance with COMAR 10.34.34.
(2)
				  A pharmacy technician working in an infusion pharmacy may not perform delegated
				  pharmacy acts as set forth in COMAR
				  10.34.34.03B.
(3) A pharmacy technician working
				  in an infusion pharmacy shall:
(a) Communicate
				  immediately to the pharmacist reported changes in:
(i) Patient condition;
(ii) Patient medication list; and
(iii) Allergies; and
(b) Obtain pharmacist approval before
				  processing refills.
(4)
				  A pharmacy technician working in an infusion pharmacy may not:
(a) Except as provided in COMAR 10.34.34,
				  accept or transcribe a new or change verbal order from an licensed authorized
				  prescriber of record or the licensed authorized prescriber of record's
				  agent;
(b) Perform the clinical
				  assessment of a patient;
(c)
				  Communicate clinical matters except as required in §A(3)(a) of this
				  regulations;
(d) Provide
				  therapy-related direction to a patient or caregiver; and
(e) Create a patient care plan specific to a
				  patient's therapy.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.35 - Infusion Pharmacy Services in an Alternate Site Care Environment › Section 10.34.35.06 - Minimum Requirements for Policies and Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
The policies and procedures shall:
A. Be congruent with State regulations and
				  standards of care from accrediting bodies and professional organizations;
				  and
B. Address:
(1) Personnel:
(a) Training and Orientation;
(b) Duties; and
(c) Qualifications;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.35 - Infusion Pharmacy Services in an Alternate Site Care Environment › Section 10.34.35.07 - Training Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Personnel shall be trained in the following areas where appropriate:
(1) Patient rights and
				  responsibilities;
(2) Patient
				  safety;
(3) Performance improvement
				  program;
(4) Universal precautions
				  which are incorporated by reference in COMAR
				  10.06.01.01B
				  -1;
(5) Warehouse and equipment
				  orientation;
(6) Waste
				  management;
(7) Handling hazardous
				  substances;
(8) Policies and
				  procedures;
(9) Recognizing signs
				  of patient abuse and neglect;
(10)
				  Recognizing signs of IV drug abuse;
(11) Customer service and cultural
				  sensitivity training;
(12)
				  Emergency policies and procedures which support the continuum of patient care
				  during natural or manmade disasters; and
(13) Patient confidentiality and the Health
				  Insurance Portability and Accountability Act, 45 CFR Parts 160 and
				  164.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.35 - Infusion Pharmacy Services in an Alternate Site Care Environment › Section 10.34.35.08 - Performance Improvement Program

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  The performance improvement program shall consist of:
(1) A committee which:
(a) Consists of representation of personnel
				  and varied areas of job responsibility; and
(b) Is responsible for analysis of data,
				  reporting trends and corrective actions; and
(c) Meets at least quarterly;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.35 - Infusion Pharmacy Services in an Alternate Site Care Environment › Section 10.34.35.09 - Discontinuation of Infusion Therapy

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  If not addressed in the initial order, the infusion pharmacy shall verify an
				  end of therapy order.
B. The
				  infusion pharmacist shall:
(1) Communicate
				  with the licensed authorized prescriber of record or agent of the prescriber of
				  record to verify:
(a) An end of therapy
				  order, if not addressed in the initial order; and
(b) Parenteral infusion access device
				  disposition, including orders for removal or line maintenance; and
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.35 - Infusion Pharmacy Services in an Alternate Site Care Environment › Section 10.34.35.10 - Reference Materials

Current through Register Vol. 51, No. 14, July 12, 2024
A. An
				  infusion pharmacy shall maintain an adequate reference library to enable it to
				  prepare and dispense infusion therapy properly.
B. In addition to the requirements of COMAR
				  10.34.07.03B, an
				  infusion pharmacy's reference library shall include:
(1) Material Safety Data Sheets
				  (MSDSs);
(2) IV compatibility
				  references;
(3) Stability and
				  extended stability references;
(4)
				  Websites and electronic references authored by established medical publishers
				  recognized within the field of infusion pharmacy practice as a supplement to
				  its printed library;
(5) Pediatric
				  dosing reference, if applicable; and
(6) Appropriate clinical references for the
				  population served.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.36 - Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes › Section 10.34.36.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter applies to pharmacies and licensed pharmacists
					 serving assisted living programs or group homes as defined in Regulation .02 of
					 this chapter, except for pharmacies providing only emergency services for
					 assisted living programs or group homes.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.36 - Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes › Section 10.34.36.02 - 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) Assisted Living Program.
(a) "Assisted living program" means a
				  residential or facility-based program that provides housing and supportive
				  services, supervision, personalized assistance, health-related services, or a
				  combination of these services 24 hours a day, 7 days a week, to meet the needs
				  of individuals who are unable to perform, or who need assistance in performing,
				  the activities of daily living or instrumental activities of daily living, in a
				  way that promotes optimum dignity and independence for the
				  individuals.
(b) "Assisted living
				  program" does not include:
(i) A nursing home
				  or comprehensive care facility, as defined under Health-General Article,
				  §19-301, Annotated Code of Maryland;
(ii) A State facility, as defined under
				  Health-General Article, §10-101, Annotated Code of Maryland;
(iii) A program licensed or approved by the
				  Department under Health-General Article, Title 7 or Title 10, Annotated Code of
				  Maryland;
(iv) A hospice care
				  program licensed by the Department under Health-General Article, Title 19,
				  Annotated Code of Maryland;
(v)
				  Services provided by family members;
(vi) Services provided by a licensed
				  residential service agency or licensed home health agency in an individual's
				  own home; or
(vii) A Certified
				  Adult Residential Environment Program that is certified by the Department of
				  Human Resources under Article 88A, § 140, Annotated Code of
				  Maryland.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.36 - Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes › Section 10.34.36.03 - 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 residents of the assisted living program or group
				  home;
C. Determines under what
				  circumstances 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 assisted living
				  program;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.36 - Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes › Section 10.34.36.04 - Personnel

Current through Register Vol. 51, No. 14, July 12, 2024
A. The permit
				  holder shall appoint a responsible pharmacist who shall:
(1) Be 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;
(2) Be
				  responsible for reviewing the policies and procedures manual of the pharmacy
				  annually and revising it as necessary;
(3) Be responsible for the safe and efficient
				  dispensing, delivery, and control of, and be accountable for, medications and
				  devices dispensed or distributed by the pharmacy;
(4) Work in cooperation with the other
				  professional staff of the assisted living program or group home in meeting the
				  responsibilities set forth in Regulation .06 of this chapter and in ordering,
				  storing, and accounting for pharmaceutical materials; and
(5) Develop a process for the pharmacy to be
				  notified of medications which have been discontinued.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.36 - Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes › Section 10.34.36.05 - Physical Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Storage. The permit holder 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) Segregation; and
(6) Security.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.36 - Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes › Section 10.34.36.06 - Medication and Device Distribution and Pharmaceutical Services

Current through Register Vol. 51, No. 14, July 12, 2024
A. The responsible
				  pharmacist shall be accountable for, at a minimum:
(1) The preparation of medications compounded
				  in the pharmacy as applicable;
(2)
				  The proper preparation, storage, and distribution of compounded sterile
				  preparations according to COMAR 10.34.19 to the extent that the functions are
				  performed at the pharmacy;
(3) The
				  packaging and labeling of medications;
(4) Records of transactions of the pharmacy
				  as may be required by applicable law and as may be necessary to maintain
				  accurate control over and accountability for pharmaceuticals;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.36 - Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes › Section 10.34.36.07 - 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 10.34.36 - Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes › Section 10.34.36.08 - Labeling of Resident Medications

Current through Register Vol. 51, No. 14, July 12, 2024
A. A licensed pharmacist shall ensure that
				  medications dispensed by the pharmacy and intended for use within an assisted
				  living program or group home 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 resident, patient, or consumer, as appropriate;
(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;
(9) Directions for use as set forth in the:
(a) Medication administration record;
				  and
(b) Prescriber's orders;
				  and
(10) Further
				  cautionary information as may be required or necessary for proper use of the
				  medication.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.36 - Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes › Section 10.34.36.09 - Drug Control and Accountability

Current through Register Vol. 51, No. 14, July 12, 2024
A. 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) A licensed pharmacist determines that
				  procedures are in place 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 10.34.36 - Pharmaceutical Services to Residents in Assisted Living Programs and Group Homes › Section 10.34.36.10 - Quality Management

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  responsible pharmacist, in cooperation with the appropriate committee of the
				  assisted living program, shall develop procedures for an ongoing quality
				  management program that includes a mechanism for reviewing and evaluating
				  pharmaceutical services as defined in this chapter and COMAR
				  10.07.14.29 where
				  appropriate.
B. The responsible
				  pharmacist, in cooperation with the appropriate committee of the group home, if
				  applicable, may develop 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 10.34.37 - Pharmacy Permit Holder Requirements - Wholesale Distribution and Nonresident Pharmacy Operations › Section 10.34.37.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter establishes requirements for a pharmacy
					 licensed by the Maryland Board of Pharmacy that:
A. Engages in wholesale distribution;
				  or
B. Operates as a nonresident
				  pharmacy.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.37 - Pharmacy Permit Holder Requirements - Wholesale Distribution and Nonresident Pharmacy Operations › Section 10.34.37.02 - Pharmacies Issued a Waiver Permit

Current through Register Vol. 51, No. 14, July 12, 2024
A. A pharmacy that is issued a waiver permit
				  by the Board under Health Occupations Article, §
										12-403(c),
				  Annotated Code of Maryland, may engage in wholesale distribution, provided
				  that:
(1) The waiver pharmacy only engages in
				  wholesale distribution with another pharmacy; and
(2) The wholesale distribution business does
				  not exceed 5 percent of the waiver pharmacy's annual sales.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.37 - Pharmacy Permit Holder Requirements - Wholesale Distribution and Nonresident Pharmacy Operations › Section 10.34.37.03 - Requirements for Wholesale Distribution

Current through Register Vol. 51, No. 14, July 12, 2024
A. General Requirements.
(1) A full service pharmacy may conduct
				  wholesale distribution provided that the wholesale distribution business does
				  not exceed 5 percent of the full service pharmacy's annual sales.
(2) A full service pharmacy may conduct
				  wholesale distribution:
(a) With another
				  pharmacy; or
(b) With a wholesale
				  distributor, if the full service pharmacy reports to the Board within a week,
				  on a form approved by the Board, of the full service pharmacy's wholesale
				  distribution to a wholesale distributor.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.38 - Pharmacy Interns › Section 10.34.38.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
A. This chapter
				  applies to applicants for registration as pharmacy interns and to registered
				  pharmacy interns.
B. This chapter
				  does not apply to pharmacy students:
(1) In a
				  school of pharmacy sanctioned experiential learning program; or
(2) Registered as pharmacy technicians with
				  the Board performing delegated pharmacy acts.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.38 - Pharmacy Interns › Section 10.34.38.02 - 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) "Direct supervision"
				  means that a licensed pharmacist is physically available, notwithstanding
				  appropriate breaks, on-site and in the prescription area or in an area where
				  pharmacy services are provided to supervise the practice of pharmacy and
				  delegated pharmacy acts.
(3)
				  "Pharmacy student" means an individual who is enrolled as a student in a school
				  or college of pharmacy:
(a) Accredited by the
				  Accreditation Council for Pharmacy Education; or
(b) Having precandidate or candidate status
				  by the Accreditation Council for Pharmacy Education.
(4) "Registered pharmacy intern" means an
				  individual who is registered with the Board to practice pharmacy under the
				  direct supervision of a pharmacist
(5) "Registration" means in this chapter,
				  unless the context requires otherwise, a registration issued by the Board to
				  practice pharmacy under the direct supervision of a licensed pharmacist
(6) "Supervision" means reviewing
				  the work, guiding and directing the activities, and monitoring the performance
				  of an individual.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.38 - Pharmacy Interns › Section 10.34.38.03 - Prohibited Pharmacy Acts

Current through Register Vol. 51, No. 14, July 12, 2024
A registered pharmacy intern may not:
A. Delegate a pharmacy act;
B. Perform a final verification of a
				  prescription drug or device before dispensing;
C. Perform any act that has not been
				  authorized by the supervising pharmacist;
D. Represent themselves as a pharmacist;
E. Dispense prescription
				  medications when the pharmacist is not in the pharmacy;
F. Be present in the pharmacy when the
				  pharmacist is not physically available onsite;
G. Act within the parameters of a therapy
				  management contract as provided under Health Occupations Article, Subtitle 6A,
				  Annotated Code of Maryland;
H
				  Independently compound prescriptions; or
I Accept the return of prescription drugs or
				  devices directly from a patient
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.38 - Pharmacy Interns › Section 10.34.38.04 - General Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Each registered pharmacy intern shall:
(1)
				  Display the pharmacy intern's registration in the office or place of business
				  in which the pharmacy intern is practicing pharmacy under the direct
				  supervision of a licensed pharmacist; or
(2) Have the registration on the pharmacy
				  intern's person available for viewing.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.38 - Pharmacy Interns › Section 10.34.38.05 - Limitation on Supervision

Current through Register Vol. 51, No. 14, July 12, 2024
A licensed pharmacist may not directly supervise more than
					 two registered pharmacy interns at one time.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.38 - Pharmacy Interns › Section 10.34.38.06 - Registration Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. An
				  applicant shall be an individual who:
(1) Is
				  currently enrolled and has completed 1 year of professional pharmacy education
				  in a doctor of pharmacy program:
(a)
				  Accredited by the Accreditation Council for Pharmacy Education; or
(b) Having precandidate or candidate status
				  by the Accreditation Council for Pharmacy Education;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.38 - Pharmacy Interns › Section 10.34.38.07 - Renewal Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  pharmacy intern's registration shall expire on the last day of the birth month
				  following 1 year after initial registration.
B. Except as provided in §C of this
				  regulation, the Board shall send to each registrant, at least 1 month before a
				  registration expires, a renewal notice by first-class mail to the last known
				  address of the registrant.
C. If
				  requested by a registrant, the Board shall send to the registrant, at least two
				  times within the month before a registration expires, a renewal notice by
				  electronic means to the last known electronic address of the registrant.
D. If a renewal notice sent by
				  electronic means under §C of this regulation is returned to the Board as
				  undeliverable, the Board shall send to the registrant a renewal notice by
				  first-class mail to the last known address of the registrant.
E. A renewal notice sent under this
				  regulation shall state:
(1) The date on which
				  the current registration expires;
(2) The date by which the renewal application
				  must be received by the Board for the renewal to be issued and mailed before
				  the registration expires; and
(3)
				  The amount of the renewal fee.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.39 - Pharmacist Administration of Self-Administered Drugs › Section 10.34.39.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter does not limit or affect the right of an
					 individual to practice a health occupation that the individual is authorized to
					 practice.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.39 - Pharmacist Administration of Self-Administered Drugs › Section 10.34.39.03 - Requirements to Administer Self-Administered Drugs

Current through Register Vol. 51, No. 14, July 12, 2024
A. A licensed pharmacist shall attest that
				  the pharmacist has the appropriate training in administration of
				  self-administered drugs that consists of instruction on:
(1) Ear drops;
(2) Eye drops;
(3) Inhalation therapies;
(4) Intramuscular injections;
(5) Intranasal therapies;
(6) Subcutaneous injections; and
(7) Topical therapies.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.39 - Pharmacist Administration of Self-Administered Drugs › Section 10.34.39.04 - Record Keeping

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  pharmacist shall document in the patient record the administration of a
				  self-administered drug that includes the following information:
(1) Name of the drug;
(2) Dosage administered;
(3) Site of administration;
(4) Date and time of administration;
				  and
(5) Any instructions provided
				  to the patient.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.40 - Pharmacists Prescribing Contraceptives › Section 10.34.40.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter does not limit or otherwise affect the right
					 of an individual to practice pharmacy or any other health occupation that the
					 individual is authorized to practice.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.40 - Pharmacists Prescribing Contraceptives › Section 10.34.40.02 - 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 Maryland Board of
				  Pharmacy.
(2) "Contraceptives"
				  means contraceptive medications and self-administered contraceptive devices
				  approved by the U.S. Food and Drug Administration.
(3) "Pharmacist" means an individual who
				  practices pharmacy under the Health Occupations Article, §
											12-101, Annotated
				  Code of Maryland.
(4) "Pharmacy"
				  means an establishment holding a permit under Health Occupations Article,
				  §
											12-401, Annotated
				  Code of Maryland.
(5) "Practicing
				  pharmacy" has the same meaning stated in Health Occupations Article, §
											12-101(x),
				  Annotated Code of Maryland.
(6)
				  "Primary care practitioner" means a licensed health care practitioner who:
(a) Provides an individual's primary care
				  services; and
(b) Is the primary
				  coordinator of health care services for the individual.
(7) "Reproductive health care practitioner"
				  means a licensed health care practitioner who provides an individual's
				  reproductive health services.
(8)
				  "Visitsummary" means:
(a) A written record of
				  either the contraceptives dispensed or a brief explanation as to why
				  contraceptives were not prescribed;
(b) Written information about the importance
				  of seeing the patient's primary care practitioner or reproductive health care
				  practitioner to obtain recommended tests and screenings; and
(c) A copy of the patient's completed
				  Self-Screening Risk Assessment Questionnaire.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.40 - Pharmacists Prescribing Contraceptives › Section 10.34.40.03 - Requirements to Prescribe Contraceptives

Current through Register Vol. 51, No. 14, July 12, 2024
A. Board Responsibilities. The Board shall
				  develop and adopt the following items, in consultation with stakeholders to be
				  determined by the Board:
(1) A self-screening
				  risk assessment questionnaire that a patient shall complete before a pharmacist
				  may prescribe contraceptives for a patient;
(2) A standard procedure contraceptive
				  algorithm which the pharmacist shall use to perform a patient assessment for
				  purposes of determining:
(a) Whether to
				  prescribe contraceptives; and
(b)
				  Which contraceptive options to prescribe;
(3) A notification form to be submitted by a
				  pharmacist before prescribing contraceptives; and
(4) Other forms and procedures for:
(a) The prescription of contraceptives;
				  and
(b) Referral to a primary care
				  or reproductive health care practitioner for treatment.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.40 - Pharmacists Prescribing Contraceptives › Section 10.34.40.04 - Training Program Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
At a minimum, a Board-approved training program shall
					 contain the following elements:
A. An
				  overview of contraceptive medications and self-administered contraceptive
				  devices;
B. An overview of the
				  self-screening risk assessment questionnaire;
C. An overview of the standard procedure
				  contraceptive algorithm; and
D. An
				  overview of the U.S. Medical Eligibility Criteria for Contraceptive Use and
				  other Center for Disease Control guidance on contraception.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.40 - Pharmacists Prescribing Contraceptives › Section 10.34.40.05 - Record Keeping

Current through Register Vol. 51, No. 14, July 12, 2024
For a minimum of 5 years, a pharmacy whose pharmacists
					 prescribe contraceptives shall maintain documentation, in electronic or other
					 form, which includes:
A. The type of
				  contraceptive prescribed, and dosage, if applicable, or the basis for not
				  prescribing a contraceptive;
B. The
				  name, address, and date of birth of the patient;
C. The name of the pharmacist who prescribed
				  the contraceptive or determined a contraceptive would not be
				  prescribed;
D. The date the
				  contraceptive was prescribed or that the patient was advised that a
				  contraceptive would not be prescribed;
E. A copy of the patient's visit
				  summary;
F. A copy of the patient's
				  self screening risk assessment questionnaire; and
G. The name and address of the:
(1) Patient's primary care practitioner or
				  reproductive health care practitioner, if provided by the patient; or
(2) Family planning provider or licensed
				  clinician who provides reproductive health care services referred by the
				  pharmacist, if the patient does not have a primary care practitioner or
				  reproductive health care practitioner.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.40 - Pharmacists Prescribing Contraceptives › Section 10.34.40.06 - Continuing Education Requirement

Current through Register Vol. 51, No. 14, July 12, 2024
A pharmacist who prescribes contraceptives in Maryland
					 shall earn 1 hour of Board-approved continuing pharmaceutical education related
					 to contraception before the pharmacist's license renewal
					 date.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.41 - Administration of a Maintenance Injectable Medication › Section 10.34.41.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter does not limit or otherwise affect the right
					 of an individual to practice pharmacy or any other health occupation that the
					 individual is authorized to practice.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.41 - Administration of a Maintenance Injectable Medication › Section 10.34.41.02 - 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) "Authorized prescriber" means a
				  practitioner licensed and authorized under Health Occupations Article,
				  Annotated Code of Maryland, to prescribe prescription drugs.
(2) "Board" means the Maryland Board of
				  Pharmacy.
(3) Maintenance
				  Injectable Medication.
(a) "Maintenance
				  injectable medication" means a medication that:
(i) Is administered by injection other than
				  intravenously;
(ii) Except as
				  authorized for a self-administered drug pursuant to Health Occupations Article,
				  §
													12-509, Annotated
				  Code of Maryland, is not a biological product; and
(iii) Treats a chronic need, condition, or
				  disorder.
(b)
				  "Maintenance injectable medication" includes, but is not limited to, a
				  medication for:
(i) The treatment of a
				  psychiatric disorder;
(ii) The
				  treatment of a substance use disorder;
(iii) Contraception; and
(iv) Vitamins.
(4) "Pharmacist" means an individual who
				  practices pharmacy under Health Occupations Article, §
											12-101, Annotated
				  Code of Maryland.
(5) "Practicing
				  pharmacy" has the meaning stated in Health Occupations Article, §
											12-101(x),
				  Annotated Code of Maryland.
(6)
				  "Primary care practitioner" means a licensed health care practitioner who
				  provides an individual's primary care services and is the primary coordinator
				  of health care services for the individual.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.41 - Administration of a Maintenance Injectable Medication › Section 10.34.41.03 - Requirements to Administer a Maintenance Injectable Medication-Pharmacist's Responsibilities

Current through Register Vol. 51, No. 14, July 12, 2024
A. Upon
				  completion of all requirements established by the Board in this chapter, and
				  after review of all relevant information, a pharmacist may administer a
				  maintenance injectable medication.
B. In order to administer a maintenance
				  injectable medication, a pharmacist shall:
(1) Utilize and follow the Board-approved
				  procedure set forth in Regulation .07 of this chapter to administer a
				  maintenance injectable medication;
(2) Refer a patient for additional care to
				  the patient's primary care practitioner or the authorized prescriber, if
				  necessary;
(3) Provide the patient
				  and the authorized prescriber with a copy of the visit summary, including a
				  written record of the maintenance injectable medication that was
				  administered;
(4) Document the
				  encounter and maintain records pursuant to Regulation .05 of this chapter;
				  and
(5) Notify the authorized
				  prescriber that the medication was administered to the specific patient and any
				  relevant information about the patient's condition.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.41 - Administration of a Maintenance Injectable Medication › Section 10.34.41.04 - Training Program Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Except as provided in §C of this regulation, a pharmacist shall
				  successfully complete a Board-approved training program for the administration
				  of injectable maintenance medications prior to administering injectable
				  maintenance medications.
B. At a
				  minimum, a Board-approved training program consists of the following elements:
(1) Administration of a maintenance
				  injectable medication;
(2)
				  Management of the patient populations served by a pharmacist;
(3) Knowledge of the specific maintenance
				  injectable medications that a pharmacist may administer; and
(4) Current guidelines relating to the
				  specific patient populations served by a pharmacist and the specific
				  maintenance injectable medications that a pharmacist may administer, if
				  applicable.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.41 - Administration of a Maintenance Injectable Medication › Section 10.34.41.05 - Record Keeping

Current through Register Vol. 51, No. 14, July 12, 2024
A. A pharmacy
				  that staffs a pharmacist that administers a maintenance injectable medication
				  shall maintain the records of a minor patient, including the information listed
				  in §B of this regulation, until the minor patient attains the age of
				  majority plus 3 years or for 5 years after the record was made, whichever is
				  later.
B. For a minimum of 5 years,
				  except for records related to minors, a pharmacy that staffs a pharmacist that
				  administers a maintenance injectable medication shall maintain documentation,
				  in electronic or other form, including:
(1)
				  The type and dose of maintenance injectable medication administered;
(2) The name, address, and date of birth of
				  the patient;
(3) The name of the
				  pharmacist who administered the maintenance injectable medication;
(4) The date that the maintenance injectable
				  medication was administered;
(5) A
				  copy of the patient's visit summary, including any pertinent details about the
				  patient's condition; and
(6) The
				  name and address of the authorized prescriber of the maintenance injectable
				  medication.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.41 - Administration of a Maintenance Injectable Medication › Section 10.34.41.06 - Patient Information and Consent

Current through Register Vol. 51, No. 14, July 12, 2024
A. A pharmacist that administers a
				  maintenance injectable medication shall:
(1)
				  Obtain a paper or electronic consent form signed by the patient, or the
				  patient's legal guardian, that authorizes the pharmacist to administer the
				  maintenance injectable medication;
(2) Provide the patient, or the patient's
				  legal guardian, with a copy of the consent form for future reference upon
				  request;
(3) Provide the patient,
				  or the patient's legal guardian, and the authorized prescriber with a copy of
				  the visit summary, including a written record of the maintenance injectable
				  medication that was administered; and
(4) Notify the patient of the need to attend
				  any upcoming appointments the patient has scheduled with the prescriber for
				  additional care.