Texas Administrative Code › Title 22 - EXAMINING BOARDS › Part 15 - TEXAS STATE BOARD OF PHARMACY › Chapter 291 - PHARMACIES › Subchapter G - SERVICES PROVIDED BY PHARMACIES › Section 291.121 - Remote Pharmacy Services

Current through Reg. 49, No. 28; July 12, 2024
(a) Remote pharmacy
				  services using automated pharmacy systems.
(1) Purpose. The purpose of this section is
				  to provide standards for the provision of pharmacy services by a Class A or
				  Class C pharmacy in a facility that is not at the same location as the Class A
				  or Class C pharmacy through an automated pharmacy system as outlined in
				  §562.109 of the Texas Pharmacy Act.
(2) Definitions. The following words and
				  terms, when used in this section, shall have the following meanings, unless the
				  context clearly indicates otherwise. All other words and terms shall have the
				  meanings defined in the Act.
(A) Automated
				  pharmacy system--A mechanical system that dispenses prescription drugs and
				  maintains related transaction information.
(B) Prepackaging--The act of repackaging and
				  relabeling quantities of drug products from a manufacturer's original
				  commercial container, or quantities of unit dosed drugs, into another cartridge
				  or container for dispensing by a pharmacist using an automated pharmacy
				  system.
(C) Provider pharmacy--The
				  community pharmacy (Class A) or the institutional pharmacy (Class C) providing
				  remote pharmacy services.
(D)
				  Remote pharmacy service--The provision of pharmacy services, including the
				  storage and dispensing of prescription drugs, in remote sites.
(E) Remote site--A facility not located at
				  the same location as a Class A or Class C pharmacy, at which remote pharmacy
				  services are provided using an automated pharmacy dispensing system.
(F) Unit dose--An amount of a drug packaged
				  in a dosage form ready for administration to a particular patient, by the
				  prescribed route at the prescribed time, and properly labeled with name,
				  strength, and expiration date of the drug.
(3) General requirements.
(A) A provider pharmacy may provide remote
				  pharmacy services using an automated pharmacy system to a jail or prison
				  operated by or for the State of Texas, a jail or prison operated by local
				  government or a healthcare facility regulated under Chapter
				  142,
				  241,
				  242,
				  247,
				  252,
				  464,
				  534, or
				  577, Health
				  and Safety Code, provided drugs are administered by a licensed healthcare
				  professional working in the jail, prison, or healthcare facility.
(B) A provider pharmacy may provide remote
				  pharmacy services at more than one remote site.
(C) Before providing remote pharmacy
				  services, the automated pharmacy system at the remote site must be tested by
				  the provider pharmacy and found to dispense accurately. The provider pharmacy
				  shall make the results of such testing available to the board upon
				  request.
(D) A provider pharmacy
				  which is licensed as an institutional (Class C) pharmacy is required to comply
				  with the provisions of §§
												291.31-
				  291.34 of this title (relating to
				  Definitions, Personnel, Operational Standards, and Records, respectively) and
				  this section.
(E) The
				  pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy
				  operations involving the automated pharmacy system located at the remote site
				  including supervision of the automated pharmacy system and compliance with this
				  section.
(F) A pharmacist from the
				  provider pharmacy shall be accessible at all times to respond to patients' or
				  other health professionals' questions and needs pertaining to drugs dispensed
				  through the use of the automated pharmacy system. Such access may be through a
				  24 hour pager service or telephone which is answered 24 hours a day.
(4) Operational standards.
(A) Application for permission to provide
				  pharmacy services using an automated pharmacy system.
(i) A Class A or Class C Pharmacy shall file
				  a completed application containing all information required by the board to
				  provide remote pharmacy services using an automated pharmacy system and pay the
				  application fee specified in §
													291.6(e)(1) of
				  this title (relating to Pharmacy License Fees).
(ii) Such application shall be resubmitted
				  every two years in conjunction with the application for renewal of the provider
				  pharmacy's license.
(iii) Upon
				  approval of the application, the provider pharmacy will be issued a certificate
				  which must be displayed at the remote site.
(B) Notification requirements.
(i) A provider pharmacy shall notify the
				  board in writing within ten days of a discontinuance of service, or closure of:
(I) a remote site where an automated pharmacy
				  system is operated by the pharmacy; or
(II) a remote pharmacy service at a remote
				  site.
(ii) A provider
				  pharmacy shall comply with appropriate federal and state controlled substance
				  registrations for each remote site if controlled substances are maintained
				  within an automated pharmacy system at the facility.
(iii) A provider pharmacy shall file a change
				  of location and/or name of a remote site as specified in §
													291.3 of this title (relating to
				  Notifications).
(C)
				  Environment/Security.
(i) A provider pharmacy
				  shall only store drugs at a remote site within an automated pharmacy system
				  which is locked by key, combination or other mechanical or electronic means so
				  as to prohibit access by unauthorized personnel.
(ii) An automated pharmacy system shall be
				  under the continuous supervision of a provider pharmacy pharmacist. To qualify
				  as continuous supervision, the pharmacist is not required to be physically
				  present at the site of the automated pharmacy system if the system is
				  supervised electronically by a pharmacist.
(iii) Automated pharmacy systems shall have
				  adequate security and procedures to:
(I)
				  comply with federal and state laws and regulations; and
(II) maintain patient
				  confidentiality.
(iv)
				  Access to the automated pharmacy system shall be limited to pharmacists or
				  personnel who:
(I) are designated in writing
				  by the pharmacist-in-charge; and
(II) have completed documented training
				  concerning their duties associated with the automated pharmacy
				  system.
(v) Drugs shall
				  be stored in compliance with the provisions of §
													291.15 of this title (relating to
				  Storage of Drugs) and §
													291.33(f)(2) of
				  this title including the requirements for temperature and handling of outdated
				  drugs.
(D) Prescription
				  dispensing and delivery.
(i) Drugs shall only
				  be dispensed at a remote site through an automated pharmacy system after
				  receipt of an original prescription drug order by a pharmacist at the provider
				  pharmacy in a manner authorized by §
													291.34(b) of this
				  title.
(ii) A pharmacist at the
				  provider pharmacy shall control all operations of the automated pharmacy system
				  and approve the release of the initial dose of a prescription drug order.
				  Subsequent doses from an approved prescription drug order may be removed from
				  the automated medication system after this initial approval. Any change made in
				  the prescription drug order shall require a new approval by a pharmacist to
				  release the drug.
(iii) A
				  pharmacist at the provider pharmacy shall conduct a drug regimen review as
				  specified in §
													291.33(c) of this
				  title prior to releasing a prescription drug order to the automated pharmacy
				  system.
(iv) Drugs dispensed by the
				  provider pharmacy through an automated pharmacy system shall comply with the
				  labeling or labeling alternatives specified in §
													291.33(c) of this
				  title.
(v) An automated pharmacy
				  system used to meet the emergency medication needs for residents of a remote
				  site must comply with the requirements for emergency medication kits in
				  subsection (b) of this section.
(E) Drugs.
(i) Drugs for use in an automated pharmacy
				  system shall be packaged in the original manufacturer's container or be
				  prepackaged in the provider pharmacy and labeled in compliance with the board's
				  prepackaging requirements for the class of pharmacy.
(ii) Drugs dispensed from the automated
				  pharmacy system may be returned to the pharmacy for reuse provided the drugs
				  are in sealed, tamper evident packaging which has not been opened.
(F) Stocking an automated pharmacy
				  system.
(i) Stocking of drugs in an automated
				  pharmacy system shall be completed by a pharmacist, pharmacy technician, or
				  pharmacy technician trainee under the direct supervision of a pharmacist,
				  except as provided in clause (ii) of this subparagraph.
(ii) If the automated pharmacy system uses
				  removable cartridges or containers to hold drugs, the prepackaging of the
				  cartridges or containers shall occur at the provider pharmacy unless provided
				  by an FDA approved repackager. The prepackaged cartridges or containers may be
				  sent to the remote site to be loaded into the machine by personnel designated
				  by the pharmacist-in-charge provided:
(I) a
				  pharmacist verifies the cartridge or container has been properly filled and
				  labeled;
(II) the individual
				  cartridges or containers are transported to the remote site in a secure,
				  tamper-evident container; and
(III)
				  the automated pharmacy system uses bar-coding, microchip, or other technologies
				  to ensure that the containers are accurately loaded in the automated pharmacy
				  system.
(iii) All drugs
				  to be stocked in the automated pharmacy system shall be delivered to the remote
				  site by the provider pharmacy.
(G) Quality assurance program. A pharmacy
				  that provides pharmacy services through an automated pharmacy system at a
				  remote site shall operate according to a written program for quality assurance
				  of the automated pharmacy system which:
(i)
				  requires continuous supervision of the automated pharmacy system; and
(ii) establishes mechanisms and procedures to
				  routinely test the accuracy of the automated pharmacy system at a minimum of
				  every six months and whenever any upgrade or change is made to the system and
				  documents each such activity.
(H) Policies and procedures of operation.
(i) A pharmacy that provides pharmacy
				  services through an automated pharmacy system at a remote site shall operate
				  according to written policies and procedures. The policy and procedure manual
				  shall include, but not be limited to, the following:
(I) a current list of the name and address of
				  the pharmacist-in-charge and personnel designated by the pharmacist-in-charge
				  to have access to the drugs stored in the automated pharmacy system;
(II) duties which may only be performed by a
				  pharmacist;
(III) a copy of the
				  portion of the written contract or agreement between the pharmacy and the
				  facility which outlines the services to be provided and the responsibilities
				  and accountabilities of each party relating to the operation of the automated
				  pharmacy system in fulfilling the terms of the contract in compliance with
				  federal and state laws and regulations;
(IV) date of last review/revision of the
				  policy and procedure manual; and
(V) policies and procedures for:
(-a-) security;
(-b-) operation of the automated pharmacy
				  system;
(-c-) preventative
				  maintenance of the automated pharmacy system;
(-d-) sanitation;
(-e-) storage of drugs;
(-f-) dispensing;
(-g-) supervision;
(-h-) drug procurement;
(-i-) receiving of drugs;
(-j-) delivery of drugs; and
(-k-) recordkeeping.
(ii) A pharmacy that provides
				  pharmacy services through an automated pharmacy system at a remote site shall,
				  at least annually, review its written policies and procedures, revise them if
				  necessary, and document the review.
(iii) A pharmacy providing remote pharmacy
				  services using an automated pharmacy system shall maintain a written plan for
				  recovery from an event which interrupts the ability of the automated pharmacy
				  system to dispense prescription drugs. The written plan for recovery shall
				  include:
(I) planning and preparation for
				  maintaining pharmacy services when an automated pharmacy system is experiencing
				  downtime;
(II) procedures for
				  response when an automated pharmacy system is experiencing downtime;
				  and
(III) procedures for the
				  maintenance and testing of the written plan for recovery.
(5) Records.
(A) Maintenance of records.
(i) Every record required under this section
				  must be:
(I) kept by the provider pharmacy
				  and be available, for at least two years for inspecting and copying by the
				  board or its representative and to other authorized local, state, or federal
				  law enforcement agencies; and
(II)
				  supplied by the provider pharmacy within 72 hours, if requested by an
				  authorized agent of the Texas State Board of Pharmacy. If the pharmacy
				  maintains the records in an electronic format, the requested records must be
				  provided in an electronic format if specifically requested by the board or its
				  representative. Failure to provide the records set out in this section, either
				  on site or within 72 hours, constitutes prima facie evidence of failure to keep
				  and maintain records in violation of the Act.
(ii) The provider pharmacy shall maintain
				  original prescription drug orders for drugs dispensed from an automated
				  pharmacy system in compliance with §
													291.34(b) of this
				  title.
(iii) if prescription drug
				  records are maintained in a data processing system, the system shall have a
				  workable (electronic) data retention system which can produce a separate audit
				  trail of drug usage by the provider pharmacy and each remote site for the
				  preceding two years as specified in §
													291.34(e) of this
				  title.
(B) Prescriptions.
				  Prescription drug orders shall meet the requirements of §
												291.34(b) of this
				  title.
(C) Records of dispensing.
				  Dispensing records for a prescription drug order shall be maintained by the
				  provider pharmacy in the manner required by §
												291.34(d) or (e)
				  of this title.
(D) Transaction
				  information.
(i) The automated pharmacy system
				  shall electronically record all transactions involving drugs stored in,
				  removed, or dispensed from the system.
(ii) Records of dispensing from an automated
				  pharmacy system for a patient shall be maintained by the providing pharmacy and
				  include the:
(I) identity of the 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.
(iii) Records of stocking or removal from an
				  automated pharmacy system shall be maintained by the pharmacy and include the:
(I) date;
(II) name, strength, dosage form, and
				  quantity of drug stocked or removed;
(III) name, initials, or identification code
				  of the person stocking or removing drugs from the system; and
(IV) name, initials, or identification code
				  of the pharmacist who checks and verifies that the system has been accurately
				  filled.
(E)
				  Patient medication records. Patient medication records shall be created and
				  maintained by the provider pharmacy in the manner required by §
												291.34(c) of this
				  title.
(F) Inventory.
(i) A provider pharmacy shall:
(I) keep a record of all drugs sent to and
				  returned from a remote site separate from the records of the provider pharmacy
				  and from any other remote site's records; and
(II) keep a perpetual inventory of controlled
				  substances and other drugs required to be inventoried under §
														291.17 of this title (relating to
				  Inventory Requirements) that are received and dispensed or distributed from
				  each remote site.
(ii) As
				  specified in §
													291.17 of this title, a provider
				  pharmacy shall conduct an inventory at each remote site. The following is
				  applicable to this inventory.
(I) The
				  inventory of each remote site and the provider pharmacy shall be taken on the
				  same day.
(II) The inventory of
				  each remote site shall be included with, but listed separately from, the drugs
				  of other remote sites and separately from the drugs of the provider
				  pharmacy.