| (F) 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.
(G) 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. The information on this printout shall be sorted
by drug name and list all distributions/returns for that drug chronologically.
(H) 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 clause shall be supplied by the pharmacy
within 72 hours, if requested by an authorized agent of the Texas
State Board of Pharmacy, or other authorized local, state, or federal
law enforcement or regulatory agencies.
(I) In the event that an ASC pharmacy which uses a
data processing system experiences system downtime, the pharmacy must
have an auxiliary procedure which will ensure that all data is retained
for online data entry as soon as the system is available for use again.
(4) 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.
(A) The registrant to whom the controlled substance
is to be distributed is registered under the Controlled Substances
Act to possess that controlled substance.
(B) The total number of dosage units of controlled
substances distributed by a pharmacy may not exceed 5.0% of all controlled
substances dispensed 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.
(C) If the distribution is for a Schedule III, IV,
or V controlled substance, a record shall be maintained which indicates:
(i) the actual date of distribution;
(ii) the name, strength, and quantity of controlled
substances distributed;
(iii) the name, address, and DEA registration number
of the distributing pharmacy; and
(iv) the name, address, and DEA registration number
of the pharmacy, practitioner, or other registrant to whom the controlled
substances are distributed.
(D) A pharmacy shall comply with 21 CFR 1305 regarding
the DEA order form (DEA 222) requirements when distributing a Schedule
II controlled substance.
(5) Other records. Other records to be maintained by
the pharmacy include:
(A) a log of the initials or identification codes which
identifies each pharmacist by name. The initials or identification
code shall be unique to ensure that each pharmacist 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;
(B) suppliers' invoices of dangerous drugs and controlled
substances dated and initialed or signed by the person receiving the
drugs;
(i) a pharmacist shall verify that the controlled substances
listed on the invoices were added to the pharmacy's perpetual inventory
by clearly recording his/her initials and the date of review of the
perpetual inventory; and
(ii) for controlled substances, the documents retained
must contain the name, strength, and quantity of controlled substances
distributed, and the name, address, and DEA number of both the supplier
and the receiving pharmacy;
(C) supplier's credit memos for controlled substances
and dangerous drugs;
(D) a 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 copy of the perpetual inventory on-site;
(E) reports of surrender or destruction of controlled
substances and/or dangerous drugs to an appropriate state or federal
agency or reverse distributor;
(F) records of distribution of controlled substances
and/or dangerous drugs to other pharmacies, practitioners, or registrants;
and
(G) a copy of any notification required by the Texas
Pharmacy Act or these rules, including, but not limited to, the following:
(i) reports of theft or significant loss of controlled
substances to DEA and the board;
(ii) notification of a change in pharmacist-in-charge
of a pharmacy; and
(iii) reports of a fire or other disaster which may
affect the strength, purity, or labeling of drugs, medications, devices,
or other materials used in the diagnosis or treatment of injury, illness,
and disease.
(6) Permission to maintain central records. Any pharmacy
that uses a centralized recordkeeping system for invoices and financial
data shall comply with the following procedures.
(A) Controlled substance records. Invoices and financial
data for controlled substances may be maintained at a central location
provided the following conditions are met:
(i) 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 the Code of
Federal Regulations, Title 21, §1304(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;
(ii) The pharmacy maintains a copy of the notification
required in this subparagraph; and
(iii) 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.
(B) Dangerous drug records. Invoices and financial
data for dangerous drugs may be maintained at a central location.
(C) 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.
(D) 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 §291.76 adopted to be effective October 7, 1986, 11 TexReg 4034; amended to be effective July 29, 1987, 12 TexReg 2337; amended to be effective September 14, 1988, 13 TexReg 4323; amended to be effective September 5, 1990, 15 TexReg 4810; amended to be effective September 27, 1991, 16 TexReg 5071; amended to be effective January 29, 1992, 17 TexReg 324; amended to be effective September 30, 1993, 18 TexReg 6460; amended to be effective August 31, 2000, 25 TexReg 8406; amended to be effective March 4, 2004, 29 TexReg 2000; amended to be effective June 6, 2004, 29 TexReg 5376; amended tobe effective December 3, 2006, 31 TexReg 9611; 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 10, 2011, 36 TexReg 1528; amended to be effective December 10, 2013, 38 TexReg 8847; amended to be effective September 11, 2014, 39 TexReg 7119; amended to be effective December 6, 2015, 40 TexReg 8766; amended to be effective September 11, 2016, 41 TexReg 6708; amended to be effective September 6, 2017, 42 TexReg 4467; amended to be effective June 7, 2018, 43 TexReg 3591; amended to be effective June 20, 2019, 44 TexReg 2950; amended to be effective June 9, 2021, 46 TexReg 3521; amended to be effective September 9, 2021, 46 TexReg 5551; amended to be effective March 7, 2023, 48 TexReg 1296 |
