22 Tex. Admin. Code § 291.75 - Records
(a) Maintenance of records.
(1) Every inventory or other record required
to be kept under the provisions of §
291.71 of this title (relating to
Purpose), §
291.72 of this title (relating to
Definitions), §
291.73 of this title (relating to
Personnel), §
291.74 of this title (relating to
Operational Standards), and this section contained in Institutional Pharmacy
(Class C) shall be:
(A) kept by the
institutional 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 other authorized local, state, or federal law enforcement
agencies; and
(B) supplied by the
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 a mutually agreeable electronic format if
specifically requested by the board or its representative. Failure to provide
the records set out in this subsection, either on site or within 72 hours,
constitutes prima facie evidence of failure to keep and maintain records in
violation of the Act.
(2)
Records of controlled substances listed in Schedules I and II shall be
maintained separately from all other records of the pharmacy.
(3) Records of controlled substances listed
in Schedules III - V shall be maintained separately or readily retrievable from
all other records of the pharmacy. For purposes of this subsection, readily
retrievable means that the controlled substances shall be asterisked, redlined,
or in some other manner readily identifiable apart from all other items
appearing on the record.
(4)
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 or direct imaging system, provided:
(A) the records in the alternative data
retention system contain all of the information required on the manual record;
and
(B) the alternative data
retention 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.
(b) Outpatient records.
(1) Outpatient records shall be maintained as
provided in §291.34 (relating to Records), and §291.35 (relating to
Official Prescription Requirements), in chapter 291, subchapter B of this
title.
(2) Outpatient
prescriptions, including, but not limited to, furlough and discharge
prescriptions, that are written by a practitioner must be written on a form
which meets the requirements of §
291.34(b)(7)(A)
of this title. Medication order forms or copies thereof do not meet the
requirements for outpatient forms.
(3) Controlled substances listed in Schedule
II must be written on an official prescription form in accordance with the
Texas Controlled Substances Act, §481.075, and rules promulgated pursuant
to the Texas Controlled Substances Act, unless exempted by chapter 315 of this
title (relating to Controlled Substances). Outpatient prescriptions for
Schedule II controlled substances that are exempted from the official
prescription requirement must be manually signed by the
practitioner.
(c) Patient
records.
(1) Original medication orders.
(A) Each original medication order shall bear
the following information:
(i) patient name
and room number or identification number;
(ii) drug name, strength, and dosage
form;
(iii) directions for
use;
(iv) date; and
(v) signature or electronic signature of the
practitioner or that of his or her authorized agent.
(B) Original medication orders shall be
maintained with the medication administration records of the
patients.
(2) Patient
medication records (PMR). A patient medication record shall be maintained for
each patient of the facility. The PMR shall contain at a minimum the following
information:
(A) Patient information:
(i) patient name and room number or
identification number;
(ii) gender,
and date of birth or age;
(iii)
weight and height;
(iv) known drug
sensitivities and allergies to drugs and/or food;
(v) primary diagnoses and chronic
conditions;
(vi) primary physician;
and
(vii) other drugs the patient
is receiving; and
(B)
Medication order information:
(i) date of
distribution;
(ii) drug name,
strength, and dosage form; and
(iii) directions for use.
(3) Controlled
substances records. Controlled substances records shall be maintained as
follows:
(A) All records for controlled
substances shall be maintained in a readily retrievable manner; and
(B) Controlled substances records shall be
maintained in a manner to establish receipt and distribution of all controlled
substances.
(4) Schedule
II controlled substances records. Records of controlled substances listed in
Schedule II shall be maintained as follows:
(A) Records of controlled substances listed
in Schedule II shall be maintained separately from records of controlled
substances in Schedules III, IV, and V, and all other records;
(B) An institutional pharmacy shall maintain
a perpetual inventory of any controlled substance listed in Schedule II;
and
(C) Distribution records for
controlled substances listed in Schedule II shall bear the following
information:
(i) patient's name;
(ii) prescribing or attending
practitioner;
(iii) name of drug,
dosage form, and strength;
(iv)
time and date of administration to patient and quantity administered;
(v) name, initials, or electronic signature
of the individual administering the controlled substance;
(vi) returns to the pharmacy; and
(vii) waste (waste is required to be
witnessed and cosigned, electronically or manually, by another
individual).
(5) Floor stock records.
(A) Distribution records for Schedules II - V
controlled substances floor stock shall include the following information:
(i) patient's name;
(ii) prescribing or attending
practitioner;
(iii) name of
controlled substance, dosage form, and strength;
(iv) time and date of administration to
patient;
(v) quantity
administered;
(vi) name, initials,
or electronic signature of the individual administering drug;
(vii) returns to the pharmacy; and
(viii) waste (waste is required to be
witnessed and cosigned, manually or electronically, by another
individual).
(B) The
record required by subparagraph (A) of this paragraph shall be maintained
separately from patient records.
(C) A pharmacist shall review distribution
records with medication orders on a periodic basis to verify proper usage of
drugs, not to exceed 30 days between such reviews.
(6) General requirements for records
maintained in a data processing system.
(A)
Noncompliance with data processing requirements. If a hospital pharmacy's data
processing system is not in compliance with the board's requirements, the
pharmacy must maintain a manual recordkeeping system.
(B) Requirements for backup systems. The
facility shall maintain a backup copy of information stored in the data
processing system using disk, tape, or other electronic backup system and
update this backup copy on a regular basis, at least monthly, to assure that
data is not lost due to system failure.
(C) Change or discontinuance of a data
processing system.
(i) Records of
distribution and return for all controlled substances. A pharmacy that changes
or discontinues use of a data processing system must:
(I) transfer the records to the new data
processing system; or
(II) purge
the records to a printout which contains the same information as required on
the audit trail printout as specified in paragraph (7)(B) of this subsection.
The information on this printout shall be sorted and printed by drug name and
list all distributions/returns chronologically.
(ii) Other records. A pharmacy that changes
or discontinues use of a data processing system must:
(I) transfer the records to the new data
processing system; or
(II) purge
the records to a printout which contains all of the information required on the
original document.
(iii)
Maintenance of purged records. Information purged from a data processing system
must be maintained by the pharmacy for two years from the date of initial entry
into the data processing system.
(D) Loss of data. The pharmacist-in-charge
shall report to the board in writing any significant loss of information from
the data processing system within 10 days of discovery of the loss.
(7) Data processing system
maintenance of records for the distribution and return of all controlled
substances to the pharmacy.
(A) Each time a
controlled substance is distributed from or returned to the pharmacy, a record
of such distribution or return shall be entered into the data processing
system.
(B) The data processing
system shall have the capacity to produce a hard copy printout of an audit
trail of drug distribution and return for any strength and dosage form of a
drug (by either brand or generic name or both) during a specified time period.
This printout shall contain the following information:
(i) patient's name and room number or
patient's facility identification number;
(ii) prescribing or attending practitioner's
name;
(iii) name, strength, and
dosage form of the drug product actually distributed;
(iv) total quantity distributed from and
returned to the pharmacy;
(v) if
not immediately retrievable via electronic image, the following shall also be
included on the printout:
(I) prescribing or
attending practitioner's address; and
(II) practitioner's DEA registration number,
if the medication order is for a controlled substance.
(C) An audit trail printout for
each strength and dosage form of the drugs distributed during the preceding
month shall be produced at least monthly and shall be maintained in a separate
file at the facility unless the pharmacy complies with subparagraph (D) of this
paragraph. The information on this printout shall be sorted by drug name and
list all distributions/returns for that drug chronologically.
(D) The pharmacy may elect not to produce the
monthly audit trail printout if the data processing system has a workable
(electronic) data retention system which can produce an audit trail of drug
distribution and returns for the preceding two years. The audit trail required
in this paragraph shall be supplied by the pharmacy within 72 hours, if
requested by an authorized agent of the board, or other authorized local,
state, or federal law enforcement or regulatory agencies.
(8) Failure to maintain records. Failure to
provide records set out in this subsection, either on site or within 72 hours
for whatever reason, constitutes prima facie evidence of failure to keep and
maintain records.
(9) Data
processing system downtime. In the event that a hospital pharmacy that uses a
data processing system experiences system downtime, the pharmacy must have an
auxiliary procedure which will ensure that all data is retained for on-line
data entry as soon as the system is available for use again.
(10) Ongoing clinical pharmacy program
records. If a pharmacy has an ongoing clinical pharmacy program and allows
pharmacy technicians to verify the accuracy of work performed by other pharmacy
technicians, the pharmacy must have a record of the pharmacy technicians and
the duties performed.
(d)
Distribution of controlled substances to another registrant. A pharmacy may
distribute controlled substances to a practitioner, another pharmacy or other
registrant, without being registered to distribute, under the following
conditions:
(1) The registrant to whom the
controlled substance is to be distributed is registered under the Controlled
Substances Act to dispense that controlled substance; and
(2) The total number of dosage units of
controlled substances distributed by a pharmacy may not exceed 5.0% of all
controlled substances dispensed or distributed by the pharmacy during the
12-month period in which the pharmacy is registered; if at any time it does
exceed 5.0%, the pharmacy is required to obtain an additional registration to
distribute controlled substances.
(3) If the distribution is for a Schedule
III, IV, or V controlled substance, a record shall be maintained which
indicates:
(A) the actual date of
distribution;
(B) the name,
strength, and quantity of controlled substances distributed;
(C) the name, address, and DEA registration
number of the distributing pharmacy; and
(D) the name, address, and DEA registration
number of the pharmacy, practitioner, or other registrant to whom the
controlled substances are distributed.
(4) A pharmacy shall comply with 21 CFR 1305
regarding the DEA order form (DEA 222) requirements when distributing a
Schedule II controlled substance.
(e) Other records. Other records to be
maintained by a pharmacy:
(1) a log of the
initials or identification codes which identifies pharmacy personnel by name.
The initials or identification code shall be unique to ensure that each person
can be identified, i.e., identical initials or identification codes cannot be
used. Such log shall be maintained at the pharmacy for at least seven years
from the date of the transaction;
(2) suppliers' invoices of dangerous drugs
and controlled substances; a pharmacist shall verify that the controlled drugs
listed on the invoices were actually received by clearly recording his/her
initials and the actual date of receipt of the controlled substances;
(3) suppliers' credit memos for controlled
substances and dangerous drugs;
(4)
a hard copy of inventories required by §
291.17 of this title (relating to
Inventory Requirements) except that a perpetual inventory of controlled
substances listed in Schedule II may be kept in a data processing system if the
data processing system is capable of producing a hard copy of the perpetual
inventory on-site;
(5) hard copy
reports of surrender or destruction of controlled substances and/or dangerous
drugs to an appropriate state or federal agency;
(6) a hard copy Schedule V nonprescription
register book;
(7) records of
distribution of controlled substances and/or dangerous drugs to other
pharmacies, practitioners, or registrants; and
(8) a hard copy of any notification required
by the Texas Pharmacy Act or these sections including, but not limited to, the
following:
(A) reports of theft or
significant loss of controlled substances to DEA and the board;
(B) notifications of a change in
pharmacist-in-charge of a pharmacy; and
(C) reports of a fire or other disaster which
may affect the strength, purity, or labeling of drugs, medications, devices, or
other materials used in diagnosis or treatment of injury, illness, and
disease.
(f)
Permission to maintain central records. Any pharmacy that uses a centralized
recordkeeping system for invoices and financial data shall comply with the
following procedures.
(1) Controlled substance
records. Invoices and financial data for controlled substances may be
maintained at a central location provided the following conditions are met:
(A) Prior to the initiation of central
recordkeeping, the pharmacy submits written notification by registered or
certified mail to the divisional director of DEA as required by
Title 21, Code of Federal
Regulations, §
1304.04(a), and submits a
copy of this written notification to the board. Unless the registrant is
informed by the divisional director of DEA that permission to keep central
records is denied, the pharmacy may maintain central records commencing 14 days
after receipt of notification by the divisional director;
(B) The pharmacy maintains a copy of the
notification required in subparagraph (A) of this paragraph; and
(C) The records to be maintained at the
central record location shall not include executed DEA order forms,
prescription drug orders, or controlled substance inventories, which shall be
maintained at the pharmacy.
(2) Dangerous drug records. Invoices and
financial data for dangerous drugs may be maintained at a central
location.
(3) Access to records. If
the records are kept in any form requiring special equipment to render the
records easily readable, the pharmacy shall provide access to such equipment
with the records.
(4) Delivery of
records. The pharmacy agrees to deliver all or any part of such records to the
pharmacy location within two business days of written request of a board agent
or any other authorized official.
Notes
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