| (vii) waste (waste is required to be witnessed and
cosigned, manually or electronically, by another individual).
(H) The record required by subparagraph (G) of this
paragraph shall be maintained separately from patient records.
(I) A pharmacist shall conduct an audit by randomly
comparing the distribution records required by subparagraph (G) of
this paragraph with the medication orders in the patient record on
a periodic basis to verify proper administration of drugs not to exceed
30 days between such reviews.
(2) Patient records.
(A) Each medication order or set of orders issued together
shall bear the following information:
(i) patient name;
(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, defined as a licensed nurse
employee or consultant/full or part-time pharmacist of the FEMCF.
(B) Medication orders shall be maintained with the
medication administration record in the medical records of the patient.
(3) General requirements for records maintained in
a data processing system.
(A) If an FEMCF pharmacy's data processing system is
not in compliance with the board's requirements, the pharmacy must
maintain a manual recordkeeping system.
(B) 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 to assure
that data is not lost due to system failure.
(C) 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:
(I) all of the information required on the original
document; or
(II) for records of distribution and return for all
controlled substances, the same information as required on the audit
trail printout as specified in subparagraph (F) of this paragraph.
The information on the printout shall be sorted and printed by drug
name and list all distributions and returns chronologically.
(D) 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.
(E) 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.
(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 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 board,
or other authorized local, state, or federal law enforcement or regulatory
agencies.
(I) In the event that an FEMCF 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 permanent 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;
(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 registrants;
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 hard 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:
Cont'd... |
