| (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.
|
| Source Note: The provisions of this §291.75 adopted to be effective April 23, 1982, 7 TexReg 1469; amended to be effective August 30, 1984, 9 TexReg 4450; amended to be effective October 22, 1985, 10 TexReg 3896; amended to be effective December 18, 1985, 10 TexReg 4694; amended to be effective September 14, 1988, 13 TexReg 4318; amended to be effective September 5, 1990, 15 TexReg 4810; amended to be effective September 27, 1991, 16 TexReg 5071; amended to be effective September 30, 1993, 18 TexReg 6460; amended to be effective March 16, 1995, 20 TexReg 1543; amended to be effective June 4, 2000, 25 TexReg 4816; amended to be effective August 31, 2000, 25 TexReg 8406; amended to beeffective June 6, 2004, 29 TexReg 5376; amended to be effective December 3, 2006, 31 TexReg 9610; amended to be effective September 18, 2007, 32 TexReg 6333; amended to be effective September 20, 2009, 34 TexReg 6323; amended to be effective March 11, 2010, 35 TexReg 2005; amended to be effective May 30, 2010, 35 TexReg 4177; amended to be effective June 7, 2018, 43 TexReg 3588; amended to be effective March 12, 2019, 44 TexReg 1331; amended to be effective June 20, 2019, 44 TexReg 2947; amended to be effective June 9, 2021, 46 TexReg 3520 |
