reglab/statecodes huggingface dataset:
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.11 - Disciplinary Sanctions, Monetary Penalties, and Civil Fines › Section 10.34.11.09 - Civil Fines to Pharmacists, Pharmacy Technicians, Pharmacy Interns, and Pharmacy Permit Holders

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Practicing on an Expired License. The Board may assess a civil fine against a
				  pharmacist who practices on an expired license in the amount of $1,000 per
				  month of practice past the expiration date of the license, up to a maximum fine
				  of $50,000.
B. Working on an
				  Expired Registration. The Board may assess a civil fine against a pharmacy
				  technician or pharmacy intern who works on an expired registration in the
				  amount of $25 per month of practice past the expiration date of the
				  registration, up to a maximum fine of $250.
C. Operating a Pharmacy on an Expired Permit.
				  The Board may assess a civil fine against a permit holder that operates a
				  pharmacy on an expired permit in the amount of $5,000 per month of operation
				  past the expiration date of the permit, up to a maximum fine of
				  $50,000.
D. Practicing or Operating
				  Without a License, Registration, or Pharmacy Permit.
(1) The Board may assess a civil fine of no
				  less than $5,000 and no more than $50,000 against:
(a) An individual who practices pharmacy
				  without a license; or
(b) An
				  individual or entity that operates a pharmacy without a permit.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.11 - Disciplinary Sanctions, Monetary Penalties, and Civil Fines › Section 10.34.11.10 - Civil Fines to Wholesale Distributor Permit Holders

Current through Register Vol. 51, No. 14, July 12, 2024
A. Operating on an Expired Wholesale
				  Distributor Permit. The Board may assess a civil fine against a permit holder
				  that operates on an expired wholesale distributor permit in the following
				  amount:
(1) A maximum of $10,000 per month of
				  operation past the expiration date of the permit, if the annual gross receipts
				  in Maryland of the permit holder for the previous tax year were less than
				  $10,000,000, up to a maximum fine of $500,000; or
(2) A maximum of $25,000 per month of
				  operation past the expiration date of the permit, if the annual gross receipts
				  in Maryland of the permit holder for the previous tax year were $10,000,000 or
				  more, up to a maximum fine of $500,000.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.11 - Disciplinary Sanctions, Monetary Penalties, and Civil Fines › Section 10.34.11.11 - Payment of a Penalty

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  licensee, registrant, or permit holder shall pay to the Board a penalty imposed
				  under this chapter within 30 days of the date the Board's order is issued,
				  unless the Board's order specifies otherwise.
B. Filing an appeal under State Government
				  Article, §
										10-222, Annotated
				  Code of Maryland, or Health Occupations Article, §
										12-316,
				  12-412, or
				  12-601, Annotated
				  Code of Maryland, does not automatically stay payment of a penalty imposed by
				  the Board pursuant to this chapter.
C. If a licensee, registrant, or permit
				  holder fails to pay, in whole or in part, a penalty imposed by the Board
				  pursuant to this chapter, the Board may not restore, reinstate, or renew a
				  license, registration, or permit until the penalty has been paid in
				  full.
D. In its discretion, the
				  Board may refer cases of delinquent payment to the Central Collection Unit of
				  the Department of Budget and Management to institute and maintain proceedings
				  to ensure prompt payment.
E.
				  Deposit of Monies.
(1) The Board shall pay
				  monies collected pursuant to this chapter, except for civil fines collected
				  under Regulation .09 of this chapter, into the State's General Fund.
(2) Civil Fines.
(a) The Board shall pay civil fines collected
				  under Regulation .09 of this chapter into the State Board of Pharmacy Fund, in
				  accordance with Health Occupations Article, §
												12-707(e)(2),
				  Annotated Code of Maryland.
(b) The
				  Board shall pay civil fines collected under Regulation .10 of this chapter into
				  the State's General Fund.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.12 - Removal of Expired Medications › Section 10.34.12.01 - Manufacturer's Expiration Date

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  wholesale distributor, pharmacist, or pharmacy shall distribute or hold for
				  sale medications bearing a manufacturer's expiration date pursuant to
				  21 C.F.R. §
											211.137.
B. A wholesale distributor, pharmacist, or
				  pharmacy shall have adequate and credible provisions for return of outdated
				  drugs, including but not limited to partials, through its wholesaler
				  distributor or reverse distributor.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.13 - Reinstatement of Expired Licenses for Pharmacists; and › Section 10.34.13.01 - 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) "Board" means the State Board of
				  Pharmacy.
(2) "MPJE" means the
				  Multistate Pharmacy Jurisprudence Examination.
(3) "NAPLEX" means the North American
				  Pharmacist Licensure Examination.
(4) "Reinstatement" means renewal of a
				  license after the license has expired.
(5) "Renewal" means renewing a license before
				  the date of expiration.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.13 - Reinstatement of Expired Licenses for Pharmacists; and › Section 10.34.13.02 - Reinstatement Fee

Current through Register Vol. 51, No. 14, July 12, 2024
The reinstatement fee authorized by Health Occupations
					 Article, §
										12-310(a)(2),
					 Annotated Code of Maryland, shall be as determined in COMAR
					 10.34.09.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.13 - Reinstatement of Expired Licenses for Pharmacists; and › Section 10.34.13.03 - Reinstatement Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. General
				  Requirements. A pharmacist who wishes to reinstate an expired license to
				  practice pharmacy shall:
(1) Provide evidence
				  of the completed amount of approved continuing education required by the Board
				  in COMAR 10.34.18 in conjunction with the reinstatement application;
(2) Provide evidence of good standing in any
				  other state in which the pharmacist has been licensed, if applicable;
				  and
(3) 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 10.34.13 - Reinstatement of Expired Licenses for Pharmacists; and › Section 10.34.13.04 - Waiver

Current through Register Vol. 51, No. 14, July 12, 2024
The Board may waive any of the requirements set forth in
					 Regulation .03 of this chapter in reinstating a pharmacist's expired
					 license.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.14 - Opening and Closing of Pharmacies › Section 10.34.14.01 - 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) "Closing of a pharmacy" means a licensed
				  pharmacy will cease operations for more than 7 consecutive days, except when:
(a) A licensed pharmacy is destroyed or
				  otherwise rendered inoperable, and the licensed pharmacy is moving its
				  operations to a temporary site in accordance with the Board's regulations;
				  or
(b) A licensed pharmacy is
				  undergoing a change of ownership:
(i) That
				  will not result in any cessation of pharmacy operations at the location;
				  and
(ii) The anticipated new
				  pharmacy permit holder has submitted a change of ownership application to the
				  Board at least 30 days prior to the change of ownership
				  transaction.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.14 - Opening and Closing of Pharmacies › Section 10.34.14.02 - Opening a Pharmacy

Current through Register Vol. 51, No. 14, July 12, 2024
A. To
				  apply for a pharmacy permit, an applicant shall:
(1) Submit an application to the Board on the
				  form that the Board requires;
(2)
				  Pay to the Board an application fee set by the Board in COMAR 10.34.09;
				  and
(3) Submit to an opening
				  inspection, at which time the applicant shall have, at a minimum, the
				  following:
(a) If applicable, a Class A
				  prescription balance and weights, or a prescription balance with equivalent or
				  superior sensitivity;
(b) A
				  refrigerator, solely for the storage of medications requiring refrigeration,
				  with a thermometer or a temperature monitoring device;
(c) Additional equipment to enable the
				  pharmacy to prepare and dispense prescriptions properly consistent with the
				  pharmacy's scope of practice;
(d)
				  Hot and cold running water;
(e) A
				  library of current reference sources, consistent with the pharmacy's scope of
				  practice, that is accessible to appropriate personnel;
(f) A current edition of Maryland Pharmacy
				  Laws;
(g) A security system in
				  accordance with COMAR
				  10.34.05.02B;
				  and
(h) A pharmacist on the
				  premises during the opening inspection, if prescription drugs are
				  present.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.14 - Opening and Closing of Pharmacies › Section 10.34.14.03 - Notification of Closing of a Pharmacy

Current through Register Vol. 51, No. 14, July 12, 2024
A. At least 14
				  days before a licensed pharmacy's anticipated date of closing, the pharmacy
				  permit holder shall:
(1) Notify the:
(a) Board in writing by certified mail,
				  return receipt requested, or hand delivery to the Board's office, of the day on
				  which the licensed pharmacy will close;
(b) Office of Controlled Substances
				  Administration by certified mail, return receipt requested, of the day on which
				  the licensed pharmacy will close;
(c) Public by conspicuously posting a notice
				  inside the pharmacy and on the pharmacy's website of the anticipated day on
				  which the pharmacy will close; and
(d) Pharmacy's customers who pick up a new or
				  refilled prescription via written and verbal communication of the anticipated
				  day on which the licensed pharmacy will close; and
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.14 - Opening and Closing of Pharmacies › Section 10.34.14.03-1 - Notification by Pharmacy Permit Holder of Anticipated Sale of Pharmacy Operations

Current through Register Vol. 51, No. 14, July 12, 2024
A. At least 30
				  days before a licensed pharmacy's sale or transfer of its pharmacy operations
				  at the permitted establishment, the pharmacy permit holder shall:
(1) Notify the:
(a) Board in writing by certified mail,
				  return receipt requested, or hand delivery to the Board's office; and
(b) Office of Controlled Substances
				  Administration by certified mail, return receipt requested;
				  and
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.14 - Opening and Closing of Pharmacies › Section 10.34.14.04 - Required Information and Procedure

Current through Register Vol. 51, No. 14, July 12, 2024
A. At the closing inspection of a licensed
				  pharmacy, the pharmacy permit holder shall provide to the Board, or the Board's
				  agent, information and documentation required by Regulation .05 of this
				  chapter.
B. The pharmacy permit
				  holder shall remove or completely cover indications that the premises was a
				  pharmacy within 30 days after the date the licensed pharmacy ceases to operate
				  as a pharmacy.
C. The pharmacy
				  permit holder shall notify prescription drug suppliers to the pharmacy, before
				  ceasing to operate as a pharmacy, of the date that the location will cease to
				  operate as a pharmacy.
D. The
				  pharmacy permit holder shall notify the public of the date that the pharmacy
				  will cease to operate as a pharmacy by that date.
E. The pharmacy permit holder shall notify
				  the public of the location to which the patients' records have been
				  transferred, by the date the pharmacy ceases to operate.
F. If patient records are not transferred,
				  the pharmacy permit holder shall notify the public of the:
(1) Location of the patient
				  records;
(2) Method by which the
				  patient records shall be maintained; and
(3) Procedure by which patients and other
				  authorized individuals or entities may access the patient records.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.14 - Opening and Closing of Pharmacies › Section 10.34.14.05 - Information and Documentation Due at the Closing Inspection

Current through Register Vol. 51, No. 14, July 12, 2024
Information and documentation due at the closing inspection
					 shall include:
A. The exact date on
				  which the pharmacy ceased to operate as a pharmacy;
B. A copy of the inventory required by the
				  Drug Enforcement Administration;
C.
				  The pharmacy permit and State Department of Health and Mental Hygiene
				  controlled dangerous substance registration for cancellation;
D. The names, address, telephone numbers, and
				  Drug Enforcement Administration registration numbers of the persons or business
				  entities to whom any prescription drugs in stock were returned or transferred
				  under Regulation .05 of this chapter and for any prescription files or patient
				  records transferred;
E. If
				  prescription drugs are destroyed pursuant to Regulation .06 of this chapter,
				  and Regulation .07 of this chapter does not apply to the prescription drugs,
				  the pharmacy permit holder shall provide the Board with a letter, signed under
				  oath by the pharmacy permit holder, stating the:
(1) Date, place and manner in which the
				  prescription drugs were destroyed;
(2) Names, addresses, and telephone numbers
				  of the persons responsible for destroying the prescription drugs; and
(3) Name, dosage unit, and quantity of each
				  type of prescription drug destroyed;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.14 - Opening and Closing of Pharmacies › Section 10.34.14.06 - Disposition of Prescription Drugs Other than Controlled Dangerous Substances

Current through Register Vol. 51, No. 14, July 12, 2024
With the exception of controlled dangerous substances,
					 prescription drugs in stock shall be disposed of by one or more of the
					 following means:
A. Returning them to
				  a distributor or manufacturer; or
B. Transferring them to another licensed
				  pharmacy, authorized prescriber, or other person or entity approved by the
				  Board or the Division of Drug Control.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.14 - Opening and Closing of Pharmacies › Section 10.34.14.07 - Disposition of Controlled Dangerous Substances

Current through Register Vol. 51, No. 14, July 12, 2024
The pharmacy permit holder shall comply with the procedures
					 set forth in this chapter in addition to those set forth in COMAR
					 10.19.03.10C -E
					 governing the disposal of controlled dangerous substances.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.15 - Licensure by Reciprocity › Section 10.34.15.01 - Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. An individual
				  applying for licensure as a pharmacist by reciprocity shall:
(1) Submit to the Board an application on a
				  form provided by the Board;
(2) Pay
				  to the Board the fee as specified in COMAR 10.34.09;
(3) Submit to the Board evidence of
				  completion of at least 520 hours of pharmacy experience after graduation from a
				  school or college of pharmacy approved by the Board or accredited by the
				  American Council on Pharmaceutical Education;
(4) Pass the MPJE; and
(5) Pass the exam of oral English competency
				  described in COMAR 10.34.02.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.16 - Portable Drug Kits for Licensed Home Health Agencies, Hospices, and Home Infusion Providers Licensed as Residential Services Agencies › Section 10.34.16.01 - 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) "Committee" means, in this chapter, a
				  joint committee of representatives from the Board of Pharmacy and the Board of
				  Nursing.
(2) "Portable drug kit"
				  means a container comprising prescription drugs and other emergency medical
				  supplies or drugs for use in licensed home health and licensed hospice
				  settings, and by home infusion providers licensed as residential services
				  agencies.
(3) "Prescription
				  protocol" means an order for a portable drug kit signed by the medical director
				  of a licensed home health agency, licensed general hospice, or a home infusion
				  provider licensed as a residential services agency.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.16 - Portable Drug Kits for Licensed Home Health Agencies, Hospices, and Home Infusion Providers Licensed as Residential Services Agencies › Section 10.34.16.02 - Requirements for Prescription Protocol

Current through Register Vol. 51, No. 14, July 12, 2024
Before distributing a portable drug kit, the pharmacist
					 shall ensure that the prescription protocol includes:
A. The name, strength, and quantity of a drug
				  to be included in the portable drug kit;
B. The name of the receiving agency or
				  designated agent;
C. The directions
				  for use;
D. Conditions for
				  use;
E. Contraindications for use;
				  and
F. The signature, printed name,
				  and telephone number of the physician authorizing the kit.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.16 - Portable Drug Kits for Licensed Home Health Agencies, Hospices, and Home Infusion Providers Licensed as Residential Services Agencies › Section 10.34.16.03 - Records

Current through Register Vol. 51, No. 14, July 12, 2024
A pharmacist shall:
A. File the prescription protocol in a
				  readily retrievable manner;
B.
				  Document the:
(1) Date of distribution of the
				  portable drug kit,
(2) Name of the
				  person or agency to whom the kit is delivered, and
(3) Date of delivery for each kit
				  distributed;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.16 - Portable Drug Kits for Licensed Home Health Agencies, Hospices, and Home Infusion Providers Licensed as Residential Services Agencies › Section 10.34.16.04 - Requirements of the Portable Drug Kit

Current through Register Vol. 51, No. 14, July 12, 2024
A. The pharmacist shall ensure that the
				  portable drug kit:
(1) Is sealed with a tamper
				  evident tag or other means for detecting entry to the kit;
(2) Displays on the outside of the kit:
(a) A serial number unique to the
				  kit;
(b) An expiration date which
				  reflects the earliest expiration date of any item contained in the
				  kit;
(c) The contents of the
				  kit;
(d) That the contents are or
				  are not sterile;
(e) The legend "To
				  be returned to the pharmacy within 5 days of breaking seal, with a completed
				  administration record or prescription enclosed"; and
(f) Storage requirements for the
				  contents;
(3) Contains:
(a) Only prescription drugs and
				  nonprescription items approved for the kit by a committee as defined in
				  Regulation .01B(1) of this chapter;
(b) A temperature monitor to indicate
				  maintenance of proper storage conditions; and
(c) A written administration record to be
				  completed by the licensed health care provider using the kit, which includes
				  the administration record indicating:
(i) The
				  name of the patient,
(ii) The name
				  of the prescriber,
(iii) Drug name,
				  form, and dosage,
(iv) Date the
				  drug was used or wasted,
(v) The
				  reason for administration or wastage of the drug, and
(vi) The name of the licensed health care
				  provider utilizing the kit;
(4) Displays or includes written information
				  inside the kit listing contraindications to use of the kit; and
(5) Does not contain a controlled dangerous
				  substance.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.16 - Portable Drug Kits for Licensed Home Health Agencies, Hospices, and Home Infusion Providers Licensed as Residential Services Agencies › Section 10.34.16.05 - Contents of Portable Drug Kit

Current through Register Vol. 51, No. 14, July 12, 2024
The committee shall review annually the approved
					 prescription drugs and nonprescription items to ensure that the contents of a
					 portable drug kit are appropriate.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.16 - Portable Drug Kits for Licensed Home Health Agencies, Hospices, and Home Infusion Providers Licensed as Residential Services Agencies › Section 10.34.16.06 - Distribution of Portable Drug Kits

Current through Register Vol. 51, No. 14, July 12, 2024
Portable drug kits may only be distributed to licensed
					 health care providers who are authorized by law to administer the contents of a
					 portable drug kit.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.17 - Waiver of Full Service Requirements for Recognized Pharmaceutical Specialties › Section 10.34.17.01 - 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) "Board" means the State Board of
				  Pharmacy.
(2) "Comprehensive care
				  facility" means a facility which admits patients suffering from disease,
				  disabilities, or advanced age, requiring medical service and nursing service
				  rendered by or under the supervision of a registered nurse.
(3) "Continuing care in a retirement
				  community" means providing shelter and providing either medical and nursing or
				  other health related services or making the services readily accessible through
				  the provider or an affiliate of the provider, whether or not the services are
				  specifically offered in the written agreement for shelter:
(a) To an individual who is 60 years old or
				  older and not related by blood or marriage to the provider;
(b) For the life of the individual or for a
				  period exceeding 1 year; and
(c)
				  Under one or more written agreements that require a transfer of assets or an
				  entrance fee notwithstanding periodic charges.
(4) "Full service pharmacy" means a pharmacy
				  that provides complete pharmaceutical services to the general public and does
				  not restrict or limit its services to any group of individuals.
(5) Pharmaceutical Specialty.
(a) "Pharmaceutical specialty" means a
				  limited pharmaceutical service provided by a pharmacy that:
(i) Is in or makes use of a specialized
				  setting by virtue of certain equipment, systems, location, or physical
				  structure; and
(ii) Restricts or
				  limits its services to a group or groups of individuals requiring such
				  specialty services.
(b)
				  "Pharmaceutical specialty" includes the following services:
(i) Assisted living facilities;
(ii) Comprehensive care facilities;
(iii) Developmental disabilities
				  facilities;
(iv) Home
				  infusion;
(v) Inpatient
				  hospital;
(vi) Nonsterile
				  compounding;
(vii) Nuclear
				  pharmaceutical;
(viii)
				  Research;
(ix) Sterile
				  compounding;
(x) Veterinary
				  care;
(xi) Provision of
				  pharmaceutical services across all settings of care within a continuing care in
				  a retirement community; and
(xii)
				  Other services approved by the Board.
(6) "Waiver pharmacy" means a pharmacy that
				  has been issued a waiver permit by the Board.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.17 - Waiver of Full Service Requirements for Recognized Pharmaceutical Specialties › Section 10.34.17.02 - Pharmaceutical Specialty

Current through Register Vol. 51, No. 14, July 12, 2024
A. The
				  Board may recognize as a pharmaceutical specialty not listed under Regulation
				  .01B(4) of this chapter, upon written application and supporting documentation
				  to the Board by an applicant for a waiver permit.
B. When evaluating an application for a
				  waiver pharmacy, the Board shall consider whether:
(1) The pharmaceutical specialty service is
				  necessary to meet a specific therapeutic need;
(2) The location is accessible without
				  endangering public health and safety;
(3) The pharmacy is properly equipped to
				  perform the pharmaceutical specialty;
(4) The applicant has provided a full and
				  detailed description of the pharmaceutical specialty that clearly substantiates
				  the basis for the request of a waiver permit; and
(5) A policy and procedure manual is included
				  with the application which sets forth a detailed description of the pharmacy
				  operation.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.17 - Waiver of Full Service Requirements for Recognized Pharmaceutical Specialties › Section 10.34.17.03 - Requirements of a Waiver Pharmacy

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  The Board shall issue a waiver permit to an applicant that:
(1) Meets the requirements of this chapter;
				  and
(2) Performs pharmaceutical
				  specialty services:
(a) Listed in Regulation
				  .01B(4) of this chapter; or
(b)
				  Approved by the Board.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.17 - Waiver of Full Service Requirements for Recognized Pharmaceutical Specialties › Section 10.34.17.04 - Restricted Practice

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  waiver pharmacy is restricted to the pharmaceutical specialty services approved
				  by the Board in the waiver permit.
B. A waiver pharmacy may not perform
				  functions of a full service pharmacy.
C. A full service pharmacy may perform
				  pharmaceutical specialty services as long as the full service pharmacy is able
				  to demonstrate competency in performing the pharmaceutical specialty.
D. A full service pharmacy and a waiver
				  pharmacy may operate on the same premises provided that the full service
				  pharmacy and the waiver pharmacy:
(1) Obtain
				  separate permits from the Board;
(2) Are supervised by separate licensed
				  pharmacists who are responsible for the operations of their respective
				  pharmacies at all times the pharmacies are in operation; and
(3) Maintain separate inventory and record
				  keeping for each pharmacy permit.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.18 - Continuing Education for Pharmacists › Section 10.34.18.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
These regulations govern any person who desires to renew a
					 license to practice pharmacy in Maryland.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.18 - Continuing Education for Pharmacists › Section 10.34.18.01-1 - Definitions

Current through Register Vol. 51, No. 14, July 12, 2024
A. In this chapter,
				  the following term has the meaning indicated.
B. Live Instruction.
(1) "Live instruction" means a course
				  offering the ability for the participant to have real-time interaction with the
				  presenter.
(2) "Live instruction"
				  includes programs approved by the American Council on Pharmaceutical Education
				  (ACPE) that are designated by the letter "L" in the course identification
				  number.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.18 - Continuing Education for Pharmacists › Section 10.34.18.02 - Exceptions

Current through Register Vol. 51, No. 14, July 12, 2024
A. This chapter
				  does not apply to pharmacists applying for renewal for the first renewal period
				  following the issuance of the original license, if the pharmacist obtains a
				  license within 1 year of the completion of the pharmacist's pharmaceutical
				  education.
B. The Board may grant
				  an exception from the continuing education requirements if the pharmacist
				  presents evidence that failure to comply was due to circumstances beyond the
				  pharmacist's control.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.18 - Continuing Education for Pharmacists › Section 10.34.18.03 - Requirements for Pharmacists Practicing in Maryland

Current through Register Vol. 51, No. 14, July 12, 2024
A. A pharmacist license expires on the last
				  day of the pharmacist's birth month every other year.
B. Before the expiration date of the
				  pharmacist's license, the pharmacist shall:
(1) File a renewal application;
(2) Pay any applicable fees; and
(3) Earn continuing pharmaceutical education
				  (CE) credits required by this chapter.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.18 - Continuing Education for Pharmacists › Section 10.34.18.04 - Requirements for Pharmacists Not Practicing in Maryland

Current through Register Vol. 51, No. 14, July 12, 2024
A licensed pharmacist not practicing in Maryland shall
					 fulfill the continuing education requirements of Maryland.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.18 - Continuing Education for Pharmacists › Section 10.34.18.05 - Requirements for Pharmacists who are Authorized Prescribers

Current through Register Vol. 51, No. 14, July 12, 2024
A pharmacist who is also an authorized prescriber licensed
					 by a board (in Maryland or another state) may use the continuing education (CE)
					 credits applied toward that board toward the Board of Pharmacy's CE
					 requirements.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.18 - Continuing Education for Pharmacists › Section 10.34.18.06 - Accredited Continuing Education Programs

Current through Register Vol. 51, No. 14, July 12, 2024
A. The Board and the following providers are
				  approved for any programs they offer which otherwise qualify for continuing
				  education (CE) credit:
(1) American Council
				  on Pharmaceutical Education (ACPE);
(2) Schools of pharmacy accredited by
				  ACPE;
(3) Food and Drug
				  Administration (FDA);
(4) Drug
				  Enforcement Administration (DEA); and
(5) Additional providers of programs approved
				  by the Board.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.18 - Continuing Education for Pharmacists › Section 10.34.18.07 - Acceptance of Previously Unapproved Continuing Education Programs

Current through Register Vol. 51, No. 14, July 12, 2024
A. A pharmacist who
				  completes a program of continuing education that is not previously approved by
				  the Board may request in writing that the Board approve the program for
				  credit.
B. The pharmacist making a
				  request for Board approval under §A of this regulation shall make the
				  request at least 90 days before licensed expiration.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.18 - Continuing Education for Pharmacists › Section 10.34.18.08 - Miscellaneous

Current through Register Vol. 51, No. 14, July 12, 2024
A. Credits may not
				  be carried over from one licensing renewal period to another.
B. Falsifying continuing education CE records
				  is grounds for disciplinary action.
C. The pharmacist shall use a Board approved
				  form to supply the pharmacist's CE information to the Board.
D. CE requirements imposed by the Board upon
				  a pharmacist as part of an informal action, consent order, or final order, as
				  defined in COMAR
				  10.34.01.02C,
				  shall be in addition to the requirements of this chapter.
E. Pharmacists may receive 2 CE credits for
				  attending a public Board meeting in its entirety.
(1) The Board shall issue a certificate of
				  proof of attendance at a public Board meeting.
(2) A pharmacist may not earn more than 4 CE
				  credits per renewal period for attendance of a public Board meeting.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.01 - Scope

Current through Register Vol. 51, No. 14, July 12, 2024
This chapter applies to a licensed pharmacy, sterile
					 compounding facility, or other person dispensing or distributing sterile
					 compounded preparations or sterile drug products into, out of, or within
					 Maryland engaging in:
A. Compounding
				  or mixing sterile prescription solutions or suspensions to be administered
				  parenterally or by irrigation, inhalation, or intraocular routes; and
B. Compounding of radiopharmaceuticals,
				  except where U.S. Pharmacopeia (USP) General Chapter 797 Pharmaceutical
				  Compounding-Sterile Preparations addresses radiopharmaceuticals, U.S.
				  Pharmacopeia (USP) Chapter 821 Radioactivity, and U.S. Pharmacopeia (USP)
				  Chapter 823 Radiopharmaceuticals for Positron Emission Tomography-Compounding
				  would apply.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.02 - Incorporation by Reference

Current through Register Vol. 51, No. 14, July 12, 2024
In this chapter, the following documents are incorporated
					 by reference:
A. U.S. Pharmacopeia
				  (USP) General Chapter 797 Pharmaceutical Compounding- Sterile Preparations (USP
				  797 Standards), which has been incorporated by reference in
				  21 U.S.C. §
											351(b) (as
				  amended).
B. U.S. Pharmacopeia
				  (USP) General Chapter 795 Pharmaceutical Compounding-Non-Sterile Preparations
				  (USP 795 Standards), which has been incorporated by reference in
				  21 U.S.C. §
											351(b) (as
				  amended).
C. U.S. Pharmacopeia
				  (USP) Chapter 821 Radioactivity, which has been incorporated by reference in
				  21 U.S.C. §
											351(b) (as
				  amended).
D. U.S. Pharmacopeia
				  (USP) Chapter 823 Radiopharmaceuticals for Positron Emission
				  Tomography-Compounding, which has been incorporated by reference in
				  21 U.S.C. §
											351(b) (as
				  amended).
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.03 - 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) "Adverse event" means:
(a) Any adverse patient outcome related to
				  the sterile compounding process; or
(b) Evidence of environmental contamination,
				  including microbial contamination above the threshold set forth in USP 797
				  Standards.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.04 - Sterile Compounding Facility Environment

Current through Register Vol. 51, No. 14, July 12, 2024
The compounding, preparation, and dispensing of compounded
					 sterile preparations shall be accomplished in a sterile compounding facility
					 environment subject to State and federal laws, regulations, and
					 standards.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.05 - General Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A licensed pharmacist who has appropriate practical and
					 didactic training in compounding sterile preparations, clean room technology,
					 laminar flow technology, quality assurance techniques, and clinical application
					 of intravenous drug therapy shall control and supervise the section of the
					 pharmacy that prepares compounded sterile preparations and is responsible for,
					 at a minimum, the following:
A.
				  Preparation of compounded sterile preparations within the pharmacy or
				  decentralized pharmacy;
B. Storage
				  of materials pertinent to the preparation of compounded sterile preparations,
				  including drugs, chemicals, and biologicals, and the establishment of
				  specifications for procurement of the materials;
C. Labeling of containers of compounded
				  sterile preparations compounded within the sterile compounding
				  facility;
D. Recording of
				  transactions of the sterile compounding facility as may be applicable to State
				  and federal laws and regulations, as may be necessary to maintain accurate
				  control over, and accountability for, pharmaceutical materials; and
E. Ensuring that licensed health care
				  practitioners meeting the requirements of §A of this regulation, or
				  registered pharmacy technicians under direct supervision of a licensed
				  pharmacist meeting the requirements of §A of this regulation, prepare,
				  compound, and dispense compounded sterile preparations.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.06 - Special Handling, Packaging, Labeling, and Beyond Use Dating

Current through Register Vol. 51, No. 14, July 12, 2024
A. The pharmacy
				  shall make available special handling and packaging materials to maintain
				  container integrity and drug stability of the prepared prescription orders,
				  including antineoplastic or other hazardous sterile preparations, during
				  handling and administration to the patient including:
(1) A reasonable effort to provide
				  tamper-evident packaging if appropriate to setting;
(2) Proper in-transit
				  storage consistent with preparation labeling; and
(3) Delivery to the patient within a
				  reasonable time.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.07 - Record-Keeping Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A.
				  Patient Prescription Records.
(1) The sterile
				  compounding facility shall maintain records of patient prescriptions.
(2) Patient prescription records shall
				  contain:
(a) Available medical information
				  consistent with prevailing sterile compounding standards; and
(b) The complete record of the formulations
				  of the solutions that were compounded.
(3) The pharmacy shall keep completed patient
				  prescription records in a retrievable manner for at least 5 years, either:
(a) At the inspection site; or
(b) So as to be immediately retrievable by
				  computer or other electronic means.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.08 - Batch Preparation

Current through Register Vol. 51, No. 14, July 12, 2024
A. A
				  health care practitioner may prepare batched sterile preparations for future
				  use in limited quantities supported by prior valid prescriptions or physician
				  orders before receiving a valid written prescription or medication
				  order.
B. Batch preparation of
				  specific compounded sterile preparations is acceptable if the:
(1) Health care practitioner can document a
				  history of valid prescriptions or physician orders that have been generated
				  solely within an established professional prescriber-patient-health care
				  practitioner relationship; and
(2)
				  Sterile compounding facility maintains the prescription on file for such
				  preparations dispensed.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.09 - Minimum Facility Requirements

Current through Register Vol. 51, No. 14, July 12, 2024
A. Controlled Environment.
(1) The pharmacy shall have a controlled
				  environment that meets USP 797 Standards.
(2) A health care practitioner shall ensure
				  that the controlled environment is:
(a)
				  Accessible only to designated personnel; and
(b) Used only for the preparation of
				  compounded sterile preparations, or such other tasks that require a controlled
				  environment.
(3) The
				  permit holder shall ensure that the controlled environment is:
(a) Structurally isolated from other areas
				  within the sterile compounding facility by means of restricted entry or access;
				  and
(b) Air conditioned to maintain
				  a temperature of the controlled environment according to USP 797
				  standards.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.10 - Minimum Requirements for Equipment

Current through Register Vol. 51, No. 14, July 12, 2024
A. The permit holder shall provide at least
				  the following equipment that is maintained in working order:
(1) Adequate refrigerator and freezer space
				  (if applicable);
(2) A sink and
				  wash area in the anteroom;
(3)
				  Appropriate waste containers for:
(a) Used
				  needles and syringes; and
(b)
				  Cytotoxic waste including disposable apparel used in its preparation, if
				  applicable;
(4) Laminar
				  air flow workstation or compounding aseptic isolator that meets USP 797
				  Standards, dedicated for products other than antineoplastics;
(5) If applicable to types of preparations
				  compounded, biological safety cabinet, or compounding aseptic isolator that
				  meets USP 797 Standards, dedicated for use with antineoplastics or other
				  hazardous sterile preparations;
(6)
				  Appropriate filters and filtration equipment; and
(7) A device for light/dark field
				  examination.
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.11 - Minimum Requirements for Supplies

Current through Register Vol. 51, No. 14, July 12, 2024
A sterile compounding facility engaging in compounding
					 sterile preparations shall maintain adequate stock levels of the following
					 supplies according to USP 797 Standards, including but not limited to:
A. Personal protective equipment:
(1) Sterile gloves;
(2) Masks;
(3) Non-shedding gowns;
(4) Shoe covers;
(5) Hair covers;
(6) Beard covers; and
(7) Other personal protective
				  equipment;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.12 - Minimum Requirements for Policies and Procedures

Current through Register Vol. 51, No. 14, July 12, 2024
A. The permit holder shall ensure that the
				  pharmacist or the pharmacist's designee shall maintain a policy and procedure
				  manual, reviewed annually, that sets forth in detail the permit holder's
				  standard operating procedures with regard to compounding sterile
				  preparations.
B. The permit holder
				  shall insure that the policy and procedure manual that sets forth the standard
				  operating procedures with regard to compounding sterile preparations is
				  implemented and adhered to.
C. The
				  policy and procedure manual shall include policies and procedures governing the
				  following:
(1) A risk-management program which
				  includes documentation of outcomes including, but not limited to:
(a) An incident reporting system;
(b) An adverse drug reaction reporting
				  system; and
(c) A preparation
				  contamination reporting system;
Code of Maryland Regulations › Title 10 - MARYLAND DEPARTMENT OF HEALTH › Part 4 › Subtitle 34 - BOARD OF PHARMACY › Chapter 10.34.19 - Sterile Pharmaceutical Compounding › Section 10.34.19.13 - Attire

Current through Register Vol. 51, No. 14, July 12, 2024
A. When compounding
				  sterile preparations, individuals shall comply with the following standards:
(1) Sequencing of garbing that complies with
				  USP 797 Standards;
(2) Thorough
				  hand-washing before gowning;
(3)
				  Wearing clean room garb inside the designated area at all times, which consists
				  of:
(a) A non-shedding coverall or
				  gown;
(b) Head and facial hair
				  covers;
(c) A face mask;
				  and
(d) Shoe covers;
(4) Clean room garb, with the
				  exception of sterile gloves, shall be donned and removed outside the designated
				  clean room area;
(5) All jewelry
				  shall be removed;
(6) Sterile
				  gloves are required; and
(7)
				  Make-up may not be worn in the clean room.