reglab/statecodes huggingface dataset:
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.06 - Usage Requirements for Remote Automated Medication Systems

Current through Register Vol. 51, No. 14, July 12, 2024
A. A remote
				  automated medication system may only be used if:
(1) Records concerning transactions or
				  operations are maintained in accordance with Regulation .11 of this
				  chapter;
(2) A responsible
				  pharmacist has been designated by the permit holder to supervise and manage the
				  operations of the remote automated medication system;
(3) Except for starter doses, a licensed
				  pharmacist reviews each order for medication:
(a) After the order has been entered into the
				  system; and
(b) Before the system
				  permits access to the medication;
(4) The permit holder ensures that:
(a) Patients have prompt access to pharmacy
				  services necessary for the provision of good pharmaceutical care as defined in
				  Health Occupations Article, §
												12-101, Annotated
				  Code of Maryland;
(b) The remote
				  automated medication system maintains the integrity of the information in the
				  system and protects patient confidentiality; and
(c) The remote automated medication system is
				  subject to a quality assurance program in accordance with Regulation .10 of
				  this chapter; and
(5) It
				  is designed to distribute medications in a licensed health care facility, a
				  related institution as defined in Health-General Article, §19-301,
				  Annotated Code of Maryland, or a medical facility owned and operated by a group
				  model health maintenance organization as defined in Health-General Article,
				  §19-713.6, Annotated Code of Maryland.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.07 - Stocking of Automated Medication Systems

Current through Register Vol. 51, No. 14, July 12, 2024
A. Selection of Medication for Stocking. A
				  licensed pharmacist shall verify the accuracy of medications selected for
				  stocking and replenishment of the automated medication system before the
				  medications are stocked in the system.
B. Stocking of Automated Medication System. A
				  registered pharmacy technician may stock an automated medication system
				  provided that:
(1) The pharmacy technician's
				  selection of medications is verified by a pharmacist; and
(2) The system uses positive drug
				  identification such as bar code technology.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.08 - Return of Unused Medication

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Single-Drug Unit Dose Packaging.
(1)
				  Automated medication systems that distribute medications in single-drug unit
				  dose packaging may allow for return of unused medications to the system
				  provided that:
(a) The medication is returned
				  to a designated common, secure, one-way returns bin; and
(b) A licensed pharmacist determines whether
				  the medication is in an unadulterated form.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.09 - Education and Training

Current through Register Vol. 51, No. 14, July 12, 2024
The permit holder shall ensure that individuals authorized
					 to utilize centralized, decentralized, or remote automated medication systems
					 receive initial and annual training regarding:
A. The capabilities and limitations of the
				  system;
B. Procedures for the
				  operation of the system; and
C.
				  Procedures for system downtime.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.10 - Quality Assurance Program

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  The responsible pharmacist, in consultation with the health care facility, a
				  related institution as defined in Health-General Article, §19-301,
				  Annotated Code of Maryland, or a medical facility owned and operated by a group
				  model health maintenance organization as defined in Health-General Article,
				  § 19.713.6, Annotated Code of Maryland, shall develop, maintain, and
				  review annually a quality assurance program regarding the automated medication
				  system that addresses, at minimum:
(1) A
				  testing program which includes daily accuracy sampling that verifies the
				  integrity of the system;
(2)
				  Investigation of medication errors related to the automated medication system,
				  and remedial actions taken;
(3)
				  Review of discrepancies and transaction reports to identify patterns of
				  inappropriate use and access;
(4)
				  Review of the overall functioning of the system2;
(5) Security and access:
(6) Preventative maintenance;
(7) Sanitation;
(8) Storage conditions;
(9) Inventory of drugs;
(10) Drug procurement, delivery, and
				  receipt;
(11) Record
				  keeping;
(12) Proper labeling
				  procedures; and
(13) Protocols in
				  the event of a power outage or other situation in which the services of the
				  system are interrupted, that include:
(a) A
				  plan for insuring continuity of pharmacy services to patients; and
(b) A plan for system recovery.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.11 - Record Keeping

Current through Register Vol. 51, No. 14, July 12, 2024
A. The permit
				  holder and the responsible pharmacist shall maintain records regarding the
				  automated medication system in a readily retrievable manner for at least 5
				  years.
B. The records referred to
				  in §A of this regulation shall include:
(1) Maintenance records and service
				  logs;
(2) System failure
				  reports;
(3) Documentation of
				  patient outcomes resulting from system failures;
(4) Accuracy audits and system performance
				  audits;
(5) Copies of reports and
				  analyses generated as part of the quality assurance program, including daily
				  accuracy sampling;
(6) Reports or
				  databases related to level of access and changes in the level of access to the
				  system;
(7) Training records
				  including:
(a) Contents of the training
				  program;
(b) Dates of training
				  completion; and
(c) The identity of
				  those attending the training program;
(8) Records of destruction of medication
				  waste removed from the system, to include an independent witness signature;
				  and
(9) Transaction information as
				  follows:
(a) Transactions involving
				  medications stored in or removed, dispensed, or distributed from the
				  system;
(b) Medications dispensed
				  or distributed for a patient, which shall be recorded to include the:
(i) Identity of the particular automated
				  medication system accessed;
(ii)
				  Identification of the individual accessing the system;
(iii) Date of transaction;
(iv) Name, strength, dosage form, and
				  quantity of drug accessed; and
(v)
				  Name of the patient for whom the drug was accessed; and
(c) Records of stocking or removal of
				  medications from an automated medication system, which shall include the:
(i) Date;
(ii) Name, strength, dosage form, and
				  quantity of drug stocked or removed; and
(iii) Name, initials, or identification code
				  of the individual stocking or removing drugs from the system.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.12 - Security

Current through Register Vol. 51, No. 14, July 12, 2024
A. The responsible
				  pharmacist shall ensure the security of the automated medication
				  system.
B. In order to restrict
				  access to the automated medication system to authorized individuals, the
				  responsible pharmacist shall, at a minimum:
(1) Establish a clear process of how
				  passwords will be assigned;
(2)
				  Develop procedures that prohibit the sharing of passwords and reuse of
				  passwords;
(3) Require that the
				  system database be updated daily to remove inactive passwords; and
(4) Require remote locking mechanisms for
				  refrigerated storage associated with the system.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.13 - Laws and Compendial Standards

Current through Register Vol. 51, No. 14, July 12, 2024
The responsible pharmacist shall ensure compliance with the
					 laws and compendial standards for packaging and labeling.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.28 - Automated Medication Systems › Section 10.34.28.14 - Controlled Dangerous Substances

Current through Register Vol. 51, No. 14, July 12, 2024
Controlled dangerous substances shall only be dispensed and
					 distributed in accordance with applicable State and federal statutes and
					 regulations.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.29 - Drug Therapy Management › Section 10.34.29.01 - 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) "Amendment" means a change to:
(a) A protocol or prescriber-pharmacist
				  agreement; or
(b) The parties to
				  the prescriber-pharmacist agreement.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.29 - Drug Therapy Management › Section 10.34.29.02 - Content of Protocol

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  protocol shall:
(1) Be:
(a) Written; and
(b) Condition or disease-state specific;
				  and
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.29 - Drug Therapy Management › Section 10.34.29.03 - Content of Prescriber-Pharmacist Agreement

Current through Register Vol. 51, No. 14, July 12, 2024
A. The prescriber-pharmacist agreement shall
				  contain the following:
(1) The names and
				  signatures of the physicians, podiatrists, or certified advanced practice
				  nurses with prescriptive authority and pharmacists authorized to act under a
				  therapy management contract;
(2)
				  The locations where the pharmacists may provide therapy management
				  services;
(3) The titles of the
				  protocols to which the prescriber-pharmacist agreement pertains;
(4) The methods and time frames by which
				  documentation and routine communication will occur between the physicians,
				  podiatrists, or certified advanced practice nurses with prescriptive authority
				  and the pharmacists, including the time frames in which the pharmacist will
				  fully update the patient's record in writing;
(5) The name, address, and telephone number
				  of the party to the prescriber-pharmacist agreement who is to receive
				  correspondence from the Boards related to the prescriber-pharmacist
				  agreement;
(6) A statement that the
				  physicians, podiatrists, or certified advanced practice nurses with
				  prescriptive authority and pharmacists shall comply with all State and federal
				  laws relating to patient confidentiality; and
(7) A list of devices available to the
				  pharmacists performing under the prescriber-pharmacist agreement, which are
				  relevant to the disease-states or conditions to be managed.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.29 - Drug Therapy Management › Section 10.34.29.04 - Requirements for Participation in Drug Therapy Management

Current through Register Vol. 51, No. 14, July 12, 2024
A. In order to enter into a therapy
				  management contract, a pharmacist:
(1) Shall
				  be licensed by and in good standing with the Board of Pharmacy;
(2) Shall possess a Doctor of Pharmacy degree
				  or equivalent training as established in §B of this regulation;
(3) May not have:
(a) A public final order by the Board of
				  Pharmacy disciplining the pharmacist's license within the 5 years immediately
				  before the application is submitted; or
(b) Limitations placed on the pharmacist's
				  license by the Board of Pharmacy in a public order;
(4) Shall possess relevant advanced training
				  as indicated by one of the following:
(a)
				  Certification as a specialist related to the disease state specified by the
				  protocol by:
(i) The Board of Pharmacy
				  Specialties;
(ii) The American
				  Society of Consultant Pharmacist's Certified Geriatric Practitioner
				  certification program; or
(iii)
				  Another credentialing body approved by the Board of Pharmacy; or
(b) Successful completion of:
(i) A residency accredited by the American
				  Society of Health-Systems Pharmacists, a body approved by the Board of Pharmacy
				  or offered by a body accredited by the Accreditation Council for Pharmacy
				  Education;
(ii) A certificate
				  program approved by the Board of Pharmacy;
(iii) A National Association of Boards of
				  Pharmacy credentialing examination; or
(iv) An examination approved by the Board of
				  Pharmacy;
(5)
				  Shall have successfully completed:
(a) 1,000
				  hours of relevant clinical experience; or
(b) 320 hours in a structured experience
				  program approved by the Board of Pharmacy; and
(6) Shall document training related to the
				  disease state specified in the protocol.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.29 - Drug Therapy Management › Section 10.34.29.05 - Guidelines for Use of Protocols

Current through Register Vol. 51, No. 14, July 12, 2024
A. On receipt of specific instructions from
				  the authorized prescriber regarding a specific patient, the pharmacist may
				  execute the authorized prescriber's specific instructions even if the
				  instructions deviate from the protocol.
B. The protocol may not prohibit the
				  pharmacist from providing other pharmaceutical services that are within the
				  pharmacist's scope of practice.
C.
				  Documentation of activities performed under a protocol or the authorized
				  prescriber's specific instructions shall be maintained in such a manner that it
				  is accessible to the:
(1) Authorized
				  prescriber, and
(2)
				  Pharmacist.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.29 - Drug Therapy Management › Section 10.34.29.06 - Therapy Management Contracts

Current through Register Vol. 51, No. 14, July 12, 2024
A. A therapy management contract shall be
				  signed by the:
(1) Authorized prescriber or
				  authorized prescribers involved in the management of the patient under a
				  prescriber-pharmacist agreement;
(2) Pharmacist or pharmacists involved in the
				  management of the patient under a prescriber-pharmacist agreement;
				  and
(3) Patient receiving care
				  under the therapy management contract.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.29 - Drug Therapy Management › Section 10.34.29.07 - Fees

Current through Register Vol. 51, No. 14, July 12, 2024
A. Scope. This
				  regulation governs authorized prescribers and pharmacists participating in drug
				  therapy management or amendment of authorized prescribers and pharmacists that
				  participate in the prescriber-pharmacist agreements relating to drug therapy
				  management.
B. Fees. The Board of
				  Pharmacy requires a fee for the prescriber-pharmacist agreement and protocol
				  application (which includes review of the qualifications of the pharmacist
				  participants) of $100 per prescriber-pharmacist agreement.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.30 - Change to Permit-Pharmacy or Wholesale Distribution Permit Holder › Section 10.34.30.01 - Application for Name Change

Current through Register Vol. 51, No. 14, July 12, 2024
The name of an individual or entity required to possess a
					 pharmacy or wholesale distribution permit may be changed on a permit if:
A. The permit holder submits a notice of name
				  change to the Board within 30 days after the name change, on a form that the
				  Board requires;
B. The permit
				  holder submits to the Board documentation verifying the name change;
				  and
C. There is no other change in
				  the individual or entity required to possess a pharmacy or wholesale
				  distribution permit including no change in controlling ownership interest, type
				  of business entity, or location.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.30 - Change to Permit-Pharmacy or Wholesale Distribution Permit Holder › Section 10.34.30.01-1 - Hours of Operation Change Requirements (Repealed)

Current through Register Vol. 51, No. 14, July 12, 2024
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.30 - Change to Permit-Pharmacy or Wholesale Distribution Permit Holder › Section 10.34.30.02 - Application for Name Change-Fee

Current through Register Vol. 51, No. 14, July 12, 2024
There is no fee for a name change under this
					 chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.30 - Change to Permit-Pharmacy or Wholesale Distribution Permit Holder › Section 10.34.30.03 - Applications for Pharmacy or Wholesale Distributor Establishment Change of Ownership

Current through Register Vol. 51, No. 14, July 12, 2024
A. Submit
				  an initial application and fee for a pharmacy or wholesale distributor permit,
				  as applicable; and
B. Submit and
				  comply with the requirements of closing and opening operations as set forth in:
(1) COMAR 10.34.14, for pharmacies;
				  and
(2) Health Occupations Article,
				  §
											12-6C-05(d),
				  Annotated Code of Maryland, and COMAR
				  10.34.22.10, for wholesale
				  distributors.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.30 - Change to Permit-Pharmacy or Wholesale Distribution Permit Holder › Section 10.34.30.04 - Applications for Pharmacy or Wholesale Distributor Establishment Change of Location

Current through Register Vol. 51, No. 14, July 12, 2024
A. Permits
				  issued to operate a pharmacy or engage in wholesale distribution, whether
				  located in the State or outside the State, are:
(1) Not transferable; and
(2) Specific to the establishment location
				  that has undergone an opening inspection by the Board.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.30 - Change to Permit-Pharmacy or Wholesale Distribution Permit Holder › Section 10.34.30.05 - Change of Information Provided in Applications

Current through Register Vol. 51, No. 14, July 12, 2024
Notwithstanding any other reporting requirements, a permit
					 holder shall provide written notification to the Board at least 30 days prior
					 to any change in information in its application provided to the Board, to
					 include:
A. Change in hours of
				  operation; or
B. Change in the
				  physical structure of the establishment, to include any:
(1) Deviation from the floor plan submitted
				  by the permit holder as part of the application; or
(2) Other change that may affect the security
				  or storage conditions of prescription drugs or devices.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.30 - Change to Permit-Pharmacy or Wholesale Distribution Permit Holder › Section 10.34.30.06 - Incomplete Applications

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  Board may hold an incomplete initial or reinstatement application for a
				  license, registration, or permit for up to one year from the date of receipt.
B. After 1 year from the date of
				  receipt, the Board shall close a pending application that is incomplete.
C. If an application has been
				  closed under §B of this regulation, the applicant shall submit a new
				  application fee and otherwise comply with all applicable license, registration,
				  or permit requirements.
D. If an
				  applicant presents extenuating circumstances to the Board, the Board may, in
				  its sole discretion, extend the 1-year application completion period.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.31 - Dispensing or Distributing at a Setting That Does Not Possess a Pharmacy Permit › Section 10.34.31.01 - Settings

Current through Register Vol. 51, No. 14, July 12, 2024
A. If a setting
				  otherwise complies with State and federal laws, a pharmacist may request Board
				  approval to dispense or distribute at a setting that does not possess a
				  pharmacy permit if:
(1) The dispensing or
				  distribution occurs while the pharmacist is providing drug therapy management
				  services in:
(a) The office of a licensed
				  physician;
(b) A clinic;
				  or
(c) A medical facility;
				  or
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.31 - Dispensing or Distributing at a Setting That Does Not Possess a Pharmacy Permit › Section 10.34.31.02 - Pharmacist Approval

Current through Register Vol. 51, No. 14, July 12, 2024
A. Before
				  a pharmacist may dispense or distribute at a setting that does not hold a
				  pharmacy permit under Regulation .01A(1) of this chapter, the pharmacist shall
				  submit to the Board a request for approval signed by the pharmacist, which
				  includes:
(1) The name and license number of
				  the pharmacist;
(2) The scope of
				  services to be provided by the pharmacist at the nonpharmacy setting;
(3) The name and address of the nonpharmacy
				  setting where the pharmacist intends to dispense or distribute; and
(4) A statement indicating the pharmacist's
				  criminal history, if any.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.31 - Dispensing or Distributing at a Setting That Does Not Possess a Pharmacy Permit › Section 10.34.31.03 - Grounds for Denial

Current through Register Vol. 51, No. 14, July 12, 2024
The Board may deny a pharmacist's request for approval
					 under Regulation .02 of this chapter if the:
A. Pharmacist has:
(1) A pending or final disciplinary action
				  before the Board; or
(2) A criminal
				  history; or
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.31 - Dispensing or Distributing at a Setting That Does Not Possess a Pharmacy Permit › Section 10.34.31.04 - Change in Information

Current through Register Vol. 51, No. 14, July 12, 2024
If any of the information set forth in Regulation .02 of
					 this chapter changes during the effective period of the Board's
					 approval:
A. The pharmacist shall
				  immediately advise the Board in writing of the change; and
B. The change in information may cause the
				  Board to withdraw or modify the Board's approval of the nonpharmacy
				  setting.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.31 - Dispensing or Distributing at a Setting That Does Not Possess a Pharmacy Permit › Section 10.34.31.05 - Approval During Catastrophic Health Emergency

Current through Register Vol. 51, No. 14, July 12, 2024
In the event of a catastrophic health emergency proclaimed
					 by the Governor under Article 41, §2-202, Annotated Code of Maryland, or
					 by the Secretary under Health-General Article, §18-902, Annotated Code of
					 Maryland, assignment of a pharmacist to a location by the State constitutes
					 application and approval under Regulation .02 of this
					 chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.31 - Dispensing or Distributing at a Setting That Does Not Possess a Pharmacy Permit › Section 10.34.31.06 - Governing Laws

Current through Register Vol. 51, No. 14, July 12, 2024
A. Except as
				  provided in §B of this regulation, a pharmacist approved by the Board to
				  dispense or distribute at a nonpharmacy setting shall comply with the Health
				  Occupations Article, Title 12, Annotated Code of Maryland.
B. A pharmacist approved by the Board to
				  dispense or distribute at a nonpharmacy setting shall comply with the labeling,
				  storage, and record keeping requirements governing the nonpharmacy
				  setting.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.31 - Dispensing or Distributing at a Setting That Does Not Possess a Pharmacy Permit › Section 10.34.31.07 - Term and Renewal

Current through Register Vol. 51, No. 14, July 12, 2024
A. Unless
				  otherwise determined by the Board, the Board's approval of a pharmacist's
				  request to dispense or distribute at a setting that does not possess a pharmacy
				  permit is in effect until the expiration of the pharmacist's license.
B. The pharmacist shall request renewal of
				  the Board's approval when renewing the pharmacist's license.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.31 - Dispensing or Distributing at a Setting That Does Not Possess a Pharmacy Permit › Section 10.34.31.08 - Pharmacy Rendered Inoperable

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  If a pharmacy for which a permit is issued is destroyed or otherwise rendered
				  inoperable, a pharmacist may dispense or distribute from a temporary site if
				  the permit holder:
(1) Obtains approval from
				  the Board before continuing pharmacy operations from a temporary site;
				  and
(2) Ensures that the temporary
				  pharmacy site complies with State and federal laws.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.32 - Pharmacist Administration of Vaccinations › Section 10.34.32.01 - 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 10.34.32 - Pharmacist Administration of Vaccinations › Section 10.34.32.03 - Requirements to Administer Vaccinations

Current through Register Vol. 51, No. 14, July 12, 2024
A. Registration.
(1) A licensed pharmacist shall submit a
				  registration to the Board on the form that the Board requires.
(2) The registration form shall include
				  verification from the licensed pharmacist of the following:
(a) Successful completion of a certification
				  course approved by the Board of Pharmacy that includes the current guidelines
				  and recommendations of the Centers for Disease Control and Prevention regarding
				  vaccinations; and
(b) Possession of
				  an active certification in basic cardiopulmonary resuscitation obtained through
				  in-person classroom instruction.
(3) A registration authorizing a licensed
				  pharmacist to administer vaccinations expires with the expiration of the
				  license to practice pharmacy unless the licensed pharmacist has completed:
(a) Four hours of continuing education
				  credits related to vaccinations; and
(b) All other requirements for licensure
				  renewal.
(4) A licensed
				  pharmacist may not administer vaccinations until the licensed pharmacist
				  receives a written confirmation from the Board accepting the licensed
				  pharmacist's registration.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.32 - Pharmacist Administration of Vaccinations › Section 10.34.32.04 - Training Program Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
In order to administer vaccinations, the Board shall assure
					 that any course that it approves contains at a minimum the following
					 elements:
A. Responses to an emergency
				  situation as a result of the administration of a vaccination;
B. Administration of intramuscular and
				  subcutaneous injections and intranasal vaccination;
C. Record-keeping and reporting requirements;
				  and
D. Advisory Committee on
				  Immunization Practices and Centers for Disease Control guidelines for
				  vaccines.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.32 - Pharmacist Administration of Vaccinations › Section 10.34.32.05 - Record Keeping

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  pharmacy permit holder shall maintain documentation in the pharmacy from which
				  the vaccine was administered for a minimum of 5 years that includes:
(1) The name, address, and date of birth of
				  the individual receiving the vaccination;
(2) The date of administration and route and
				  site of vaccinations;
(3) The name,
				  dose, manufacturer's lot number, and expiration date of the vaccine;
(4) The name and address of the primary
				  health care provider of the individual receiving the vaccination, as identified
				  by that individual;
(5) The name of
				  the pharmacist, pharmacy student, physician, or nurse administering the
				  vaccination;
(6) The version of the
				  vaccination information statement provided to the individual receiving the
				  vaccination;
(7) The copy of the
				  signed patient consent form of those individuals to whom the vaccine was
				  administered;
(8) The nature and
				  outcome of an adverse reaction and documentation that the adverse reaction was
				  reported to:
(a) The primary care provider;
				  and
(b) The Vaccine Adverse Event
				  Reporting System.
(9) At
				  least one effort made by the pharmacist to inform the individual's authorized
				  prescriber that the vaccination has been administered; and
(10) If the authorized prescriber is not the
				  individual's primary care provider or if the vaccination has not been
				  administered in accordance with a prescription document, at least one effort
				  made by the pharmacist to inform the individual's primary care provider or
				  other usual source of care that the vaccination has been
				  administered.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.32 - Pharmacist Administration of Vaccinations › Section 10.34.32.06 - Patient Information and Consent

Current through Register Vol. 51, No. 14, July 12, 2024
A. Every patient receiving a vaccination
				  shall be provided with a current vaccine information statement.
B. Every patient receiving a vaccination
				  shall:
(1) Sign a consent form consenting to
				  the administration of the vaccine; and
(2) Be given a copy of the consent form for
				  the patient's future reference.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.32 - Pharmacist Administration of Vaccinations › Section 10.34.32.07 - Approved Protocols

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  pharmacist shall have and maintain a written protocol for any vaccine to be
				  administered, including influenza vaccination.
B. The pharmacist shall administer
				  vaccinations in accordance with the written protocol.
C. The written protocol for each vaccine
				  shall contain at least the following elements:
(1) Identity and license number of the
				  participating pharmacist;
(2)
				  Vaccine;
(3) Precautions to vaccine
				  use;
(4) Contraindications to
				  vaccine use;
(5) Process to be
				  followed for screening for:
(a)
				  Indications;
(b)
				  Precautions;
(c) Contraindications;
				  and
(d) Allergies;
(6) Process for obtaining and
				  documenting consent;
(7) Process
				  for verification of prescription for patients 11-17 years old for vaccinations
				  other than the influenza vaccine;
(8) Dose or doses of the vaccine that will be
				  administered;
(9) The route or
				  routes and site or sites of administration of the vaccine;
(10) The injection or administration
				  procedures;
(11) Post-vaccination
				  procedures, including waiting requirements;
(12) Process for handling adverse reactions,
				  including but not limited to:
(a) Acute
				  anaphylactic reactions; and
(b)
				  Other acute emergencies; and
(13) Process for documenting and maintaining
				  a vaccination record including at least:
(a)
				  Patient:
(i) Name;
(ii) Date of birth; and
(iii) Address;
(b) Vaccination administration:
(i) Date;
(ii) Dose;
(iii) Site; and
(iv) Route;
(c) Vaccine:
(i) Manufacturer;
(ii) Lot number; and
(iii) Expiration date;
(d) Required Vaccine Information Statement:
(i) Version; and
(ii) Provision date;
(e) Name of the patient's primary care
				  provider or prescriber;
(f)
				  Documentation:
(i) Of at least one attempt to
				  inform the patient's primary care provider or prescriber that the vaccination
				  has been administered; or
(ii) That
				  the patient has no primary care provider;
(g) Documentation of an attempt to inform the
				  patient's primary care provider that the influenza vaccination has been
				  administered may not be required; and
(h) The name of the vaccinator.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.32 - Pharmacist Administration of Vaccinations › Section 10.34.32.08 - Fees

Current through Register Vol. 51, No. 14, July 12, 2024
Fees charged for the administration of vaccinations may not
					 exceed $50 in addition to the cost of each vaccination.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.33 - Prescription Drug Repository Program › Section 10.34.33.01-1 - Incorporation by Reference

Current through Register Vol. 51, No. 14, July 12, 2024
In this chapter, the Secure and Responsible Drug Disposal
					 Act of 2010, 21 U.S.C.
					 822 (as amended), has been incorporated by
					 reference.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.33 - Prescription Drug Repository Program › Section 10.34.33.02 - Donation Program-Eligible Drugs

Current through Register Vol. 51, No. 14, July 12, 2024
A. Prescription drugs or medical supplies may
				  be donated at a drop-off site.
B.
				  Prescription drugs or medical supplies may be accepted for dispensing if the
				  prescription drugs and medical supplies are:
(1) In their original unopened and sealed
				  packaging; or
(2) Packaged in
				  single unit doses when the outside packaging is opened if the single unit dose
				  packaging is undisturbed.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.33 - Prescription Drug Repository Program › Section 10.34.33.03 - Donation Program-Ineligible Drugs

Current through Register Vol. 51, No. 14, July 12, 2024
A. Prescription drugs or medical supplies may
				  not be accepted for dispensing if the prescription drugs or medical supplies:
(1) Bear an expiration date that is less than
				  90 days from the date the drug is donated to ensure the potency and quality of
				  the prescription drugs or medical supplies;
(2) Have been adulterated, according to the
				  standards of Health-General Article, §21-216, Annotated Code of Maryland,
				  because adulterated prescription drugs or medical supplies have been determined
				  to be a threat to public health;
(3) Are designated controlled dangerous
				  substances by the U.S. Drug Enforcement Administration which has determined
				  that controlled dangerous substances may not be donated under a repository
				  program;
(4) Require refrigeration
				  because the potency and quality may not be guaranteed; or
(5) Have been previously compounded because
				  compounded prescription drugs are patient specific.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.33 - Prescription Drug Repository Program › Section 10.34.33.04 - Donation Program-Donor Form

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  A donor of a prescription drug or medical supply shall sign a form containing
				  the following statements:
(1) That the donor
				  is the owner or the owner's representative of the prescription drug or medical
				  supply; and
(2) That the donor
				  intends to voluntarily donate the prescription drug or medical supply to the
				  Program.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.33 - Prescription Drug Repository Program › Section 10.34.33.05 - Donation Program-Drop-Off Sites Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. In order to become a drop-off site, a
				  pharmacy or other health care facility:
(1)
				  Shall submit an application to the Board to be designated as a voluntary
				  drop-off site;
(2) Shall be in good
				  standing with the Board or the Office of Health Care Quality;
(3) May not have a final disciplinary order
				  issued against it by a health occupations board;
(4) May not be owned or operated by a health
				  care practitioner who has not fulfilled the requirements of a final
				  disciplinary order that may have been issued against the owner or operator by a
				  health occupations boards;
(5)
				  Shall maintain records of donated prescription drugs or medical supplies;
				  and
(6) Shall assign a pharmacist
				  or other health care practitioner the responsibility to accept donated
				  prescription drugs or medical supplies at the drop-off site.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.33 - Prescription Drug Repository Program › Section 10.34.33.06 - Repositories-General Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. In
				  order to become a repository, a pharmacy:
(1)
				  Shall submit an application to the Board to be designated as a
				  repository;
(1-1) Shall indicate on
				  the application to the Board if the applicant intends to:
(a) Participate in the Donation
				  Program;
(b) Participate in the
				  Disposal Program by collecting only non-controlled dangerous substances and
				  medical supplies for safe disposal; or
(c) Participate in the Disposal Program by
				  collecting controlled dangerous substances, non-controlled dangerous
				  substances, and medical supplies for safe disposal;
(2) Shall be in good standing with the
				  Board;
(3) May not have a final
				  disciplinary order issued against it by the Board; and
(4) May not be owned or operated by a health
				  care practitioner who has not fulfilled the requirements of a final
				  disciplinary order that may have been issued against the owner or operator by a
				  health occupations board.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.33 - Prescription Drug Repository Program › Section 10.34.33.06-1 - Repositories Participating in the Donation Program

Current through Register Vol. 51, No. 14, July 12, 2024
A. Designated Pharmacist. A repository in the
				  donation program shall designate a pharmacist who shall:
(1) Accept donated prescription drugs or
				  medical supplies forwarded by:
(a) A drop-off
				  site; or
(b) A manufacturer
				  regulated by the U.S. Food and Drug Administration;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.33 - Prescription Drug Repository Program › Section 10.34.33.07 - Disposal Program-Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. Pharmacies that collect returned
				  prescription drugs or medical supplies for proper disposal shall be approved by
				  the Board as repositories.
B.
				  Repositories that collect only non-controlled dangerous substances for proper
				  disposal shall:
(1) Dispose of prescription
				  drugs or medical supplies collected for disposal in compliance with applicable
				  State and federal laws and regulations;
(2) Have policies and procedures regarding
				  the safe and secure handling and disposal of prescription drugs and medical
				  supplies, to include specific guidelines for prescription drugs requiring
				  special disposal or care;
(3)
				  Dispose of collected prescription drugs and medical supplies through a third
				  party processor or a reverse distributor, as appropriate; and
(4) Maintain a separate secure container
				  behind the prescription counter that is clearly marked for the Disposal
				  Program.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.34 - Pharmacy Technicians › Section 10.34.34.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter applies to applicants for registration as
					 pharmacy technicians and to registered pharmacy technicians.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.34 - Pharmacy Technicians › Section 10.34.34.03 - Delegated Pharmacy Acts

Current through Register Vol. 51, No. 14, July 12, 2024
A. A pharmacy
				  technician may not:
(1) Represent themselves
				  as a pharmacist;
(2) Dispense
				  prescription medications when the pharmacist is not in the pharmacy;
(3) Be present in the pharmacy when the
				  pharmacist is not physically available onsite;
(4) Provide information, explanation, or
				  recommendations to patients and health care practitioners about the safe and
				  effective use of prescription or nonprescription drugs or devices;
(5) Delegate a pharmacy act that was
				  delegated to the pharmacy technician or individual engaging in a Board-approved
				  technician training program;
(6)
				  Act within the parameters of a therapy management contract as provided under
				  Health Occupations Article, Subtitle 6A, Annotated Code of Maryland;
(7) Administer an influenza vaccination in
				  accordance with Health Occupations Article, §
											12-508, Annotated
				  Code of Maryland;
(8) Provide the
				  final verification for accuracy, appropriateness, completeness, or validity of
				  a filled prescription or medication order, except as provided for in Regulation
				  .04 under this chapter;
(9) Make
				  decisions that require a pharmacist's professional judgment;
(10) Clinically evaluate the patient's
				  profile relative to the pharmaceuticals that have been or will be
				  dispensed;
(11) Consult with the
				  patient concerning the utilization of their pharmaceuticals;
(12) Accept or transcribe new
				  prescriptions;
(13) Give or accept
				  a transferred prescription for controlled dangerous substances;
(14) Accept a transferred
				  prescription;
(15) Independently
				  compound prescriptions;
(16)
				  Administer medications; or
(17)
				  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 10.34.34 - Pharmacy Technicians › Section 10.34.34.04 - Validated Pharmacy Technician

Current through Register Vol. 51, No. 14, July 12, 2024
A. Validated
				  Pharmacy Technician - Minimum Requirements.
(1) Experience. Prior to working as a
				  validated pharmacy technician, an individual shall have a minimum of 1 year of
				  experience as a registered pharmacy technician in the State.
(2) Training. In addition to the requirements
				  for pharmacy technician registration, to act as a validated pharmacy
				  technician, an individual shall possess a product verification certificate
				  issued by a Board-approved national pharmacy technician certification
				  program.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.34 - Pharmacy Technicians › Section 10.34.34.05 - Registration Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. An applicant
				  currently certified by a national pharmacy technician certification program
				  shall:
(1) Submit to the Board a signed
				  completed application on a form provided by the Board;
(2) Submit to the Board evidence of current
				  certification by a national pharmacy certification program;
(3) Pay a fee as set forth in COMAR 10.34.09;
				  and
(4) 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 10.34.34 - Pharmacy Technicians › Section 10.34.34.06 - Pharmacy Students - Exemptions

Current through Register Vol. 51, No. 14, July 12, 2024
A. Pharmacy
				  students who are practicing in a pharmacy as part of a school of pharmacy
				  sanctioned experiential learning rotation are not subject to the registration
				  requirements of Regulation .04 of this chapter.
B. Pharmacy students who are currently
				  completing the first year of a professional pharmacy education program and are
				  not in a school of pharmacy sanctioned experiential learning rotation may
				  perform delegated pharmacy acts provided that the pharmacy student:
(1) Submits to the Board a signed completed
				  application for exemption from the registration requirements of Regulation .04
				  of this chapter; and
(2) Provides
				  verification of enrollment and good standing at an accredited school of
				  pharmacy.