(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 |