| (i) Such counseling area shall:
(I) be easily accessible to both the patient and pharmacists
and not allow patient access to prescription drugs; and
(II) be designed to maintain the confidentiality and
privacy of the pharmacist/patient communication.
(ii) In determining whether the area is suitable for
confidential patient counseling and designed to maintain the confidentiality
and privacy of the pharmacist/patient communication, the board may
consider factors such as the following:
(I) the proximity of the counseling area to the check-out
or cash register area;
(II) the volume of pedestrian traffic in and around
the counseling area;
(III) the presence of walls or other barriers between
the counseling area and other areas of the pharmacy; and
(IV) any evidence of confidential information being
overheard by persons other than the patient or patient's agent or
the pharmacist or agents of the pharmacist.
(C) The satellite pharmacy shall be properly lighted
and ventilated.
(D) The temperature of the satellite pharmacy shall
be maintained within a range compatible with the proper storage of
drugs in compliance with the provisions of §291.15 of this title
(relating to Storage of Drugs). The temperature of the refrigerator
shall be maintained within a range compatible with the proper storage
of drugs requiring refrigeration.
(E) Animals, including birds and reptiles, shall not
be kept within the pharmacy and in immediately adjacent areas under
the control of the pharmacy. This provision does not apply to fish
in aquariums, guide dogs accompanying disabled persons, or animals
for sale to the general public in a separate area that is inspected
by local health jurisdictions.
(4) Security.
(A) A satellite pharmacy shall be under the continuous,
physically present supervision of a pharmacist at all times the satellite
pharmacy is open to provide pharmacy services.
(B) The satellite pharmacy shall be enclosed by walls,
partitions or other means of floor-to-ceiling enclosure. In addition
to the security requirements outlined in §291.33(b)(2) of this
title, satellite pharmacies shall have adequate security and procedures
to:
(i) prohibit unauthorized access;
(ii) comply with federal and state regulations; and
(iii) maintain patient confidentiality.
(C) Access to the satellite pharmacy shall be limited
to pharmacists, pharmacy technicians, and pharmacy technician trainees
employed by the provider pharmacy and who are designated in writing
by the pharmacist-in-charge.
(D) The provider pharmacy shall have procedures that
specify that prescriptions may only be delivered to the satellite
pharmacy by the provider pharmacy and shall:
(i) be delivered in a sealed container with a list
of the prescriptions delivered;
(ii) be signed for on receipt by the pharmacist at
the satellite pharmacy; and
(iii) be checked by personnel designated by the pharmacist-in-charge
to verify that the prescriptions sent by the provider pharmacy were
actually received. The designated person who checks the order shall
document the verification by signing and dating the list of prescriptions
delivered.
(5) Prescription dispensing and delivery. A satellite
pharmacy shall comply with the requirements outlined in §291.33(c)
of this title with regard to prescription dispensing and delivery.
(6) Equipment and supplies. A satellite pharmacy shall
have the following equipment and supplies:
(A) typewriter or comparable equipment;
(B) refrigerator, if storing drugs requiring refrigeration;
and
(C) metric-apothecary weight and measure conversion
charts.
(7) Library. A reference library shall be maintained
by the satellite pharmacy that includes the following in hard-copy
or electronic format:
(A) current copies of the following:
(i) Texas Pharmacy Act and rules;
(ii) Texas Dangerous Drug Act and rules;
(iii) Texas Controlled Substances Act and rules; and
(iv) Federal Controlled Substances Act and rules (or
official publication describing the requirements of the Federal Controlled
Substances Act and rules);
(B) at least one current or updated reference from
each of the following categories:
(i) patient information:
(I) United States Pharmacopeia Dispensing Information,
Volume II (Advice to the Patient); or
(II) a reference text or information leaflets which
provide patient information;
(ii) drug interactions: a reference text on drug interactions,
such as Drug Interaction Facts. A separate reference is not required
if other references maintained by the satellite pharmacy contain drug
interaction information including information needed to determine
severity or significance of the interaction and appropriate recommendations
or actions to be taken;
(iii) a general information reference text, such as:
(I) Facts and Comparisons with current supplements;
(II) United States Pharmacopeia Dispensing Information
Volume I (Drug Information for the Healthcare Provider);
(III) Clinical Pharmacology;
(IV) American Hospital Formulary Service with current
supplements; or
(V) Remington's Pharmaceutical Sciences; and
(C) basic antidote information and the telephone number
of the nearest Regional Poison Control Center.
(f) Records.
(1) Maintenance of records.
(A) Every record required to be kept under §291.34
of this title and under this section shall be:
(i) kept by the provider pharmacy and be available,
for at least two years from the date of such inventory or record,
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 board. 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.
(B) Records, except when specifically required to be
maintained in original or hard-copy form, may be maintained in an
alternative data retention system, such as a data processing system
or direct imaging system provided:
(i) the records maintained in the alternative system
contain all of the information required on the manual record; and
(ii) the data processing system is capable of producing
a hard copy of the record upon the request of the board, its representative,
or other authorized local, state, or federal law enforcement or regulatory
agencies.
(C) Prescription drug orders shall be maintained by
the provider pharmacy in the manner required by §291.34(d) or
(e) of this title.
(2) Prescriptions.
(A) Prescription drug orders shall meet the requirements
of §291.34(b) of this title.
(B) The provider pharmacy must maintain appropriate
records to identify the name(s), initials, or identification code(s)
and specific activity(ies) of each pharmacist, pharmacy technician,
or pharmacy technician trainee who performed any processing at the
satellite pharmacy.
(C) A provider pharmacy shall keep a record of all
prescriptions sent and returned between the pharmacies separate from
the records of the provider pharmacy and from any other satellite
pharmacy's records.
(D) A satellite pharmacy shall keep a record of all
prescriptions received and returned between the pharmacies.
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| Source Note: The provisions of this §291.129 adopted to be effective September 18, 2007, 32 TexReg 6352; amended to be effective June 7, 2009, 34 TexReg 3412; amended to be effective December 6, 2018, 43 TexReg 7787; amended to be effective December 10, 2020, 45 TexReg 8865; amended to be effective December 4, 2023, 48 TexReg 7060 |
