| (F) In lieu of the printout described in subparagraph
(C) of this paragraph, the pharmacy shall maintain a log book in which
each individual pharmacist using the data processing system shall
sign a statement each day, attesting to the fact that the information
entered into the data processing system that day has been reviewed
by him or her and is correct as entered. Such log book shall be maintained
at the pharmacy employing such a system for a period of two years
after the date of dispensing; provided, however, that the data processing
system can produce the hard copy printout on demand by an authorized
agent of the Texas State Board of Pharmacy. If no printer is available
on site, the hard copy printout shall be available within 72 hours
with a certification by the individual providing the printout, that
states that the printout is true and correct as of the date of entry
and such information has not been altered, amended, or modified.
(G) The pharmacist-in-charge is responsible for the
proper maintenance of such records and responsible that such data
processing system can produce the records outlined in this section
and that such system is in compliance with this subsection.
(H) The data processing system shall be capable of
producing a hard copy printout of an audit trail for all dispensings
(original and refill) of any specified strength and dosage form of
a drug (by either brand or generic name or both) during a specified
time period.
(i) Such audit trail shall contain all of the information
required on the daily printout as set out in subparagraph (C) of this
paragraph.
(ii) The audit trail required in this subparagraph
shall be supplied by the pharmacy within 72 hours, if requested by
an authorized agent of the Texas State Board of Pharmacy.
(I) 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.
(J) The data processing system shall provide on-line
retrieval (via computer display or hard copy printout) of the information
set out in subparagraph (C) of this paragraph of:
(i) the original controlled substance prescription
drug orders currently authorized for refilling; and
(ii) the current refill history for Schedules III,
IV, and V controlled substances for the immediately preceding six-month
period.
(K) In the event that a pharmacy that uses a data processing
system experiences system downtime, the following is applicable:
(i) an auxiliary procedure shall ensure that refills
are authorized by the original prescription drug order and that the
maximum number of refills has not been exceeded or authorization from
the prescribing practitioner shall be obtained prior to dispensing
a refill; and
(ii) all of the appropriate data shall be retained
for on-line data entry as soon as the system is available for use
again.
(3) Authorization of refills. Practitioner authorization
for additional refills of a prescription drug order shall be noted
as follows:
(A) on the hard copy prescription drug order;
(B) on the daily hard copy printout; or
(C) via the computer display.
(f) Limitation to one type of recordkeeping system.
When filing prescription drug order information a pharmacy may use
only one of the two systems described in subsection (d) or (e) of
this section.
(g) Transfer of prescription drug order information.
For the purpose of initial or refill dispensing, the transfer of original
prescription drug order information is permissible between pharmacies,
subject to the following requirements.
(1) The transfer of original prescription drug order
information for controlled substances listed in Schedule III, IV,
or V is permissible between pharmacies on a one-time basis only. However,
pharmacies electronically sharing a real-time, on-line database may
transfer up to the maximum refills permitted by law and the prescriber's
authorization.
(2) The transfer of original prescription drug order
information for dangerous drugs is permissible between pharmacies
without limitation up to the number of originally authorized refills.
(3) The transfer is communicated orally by telephone
or via facsimile directly by a pharmacist to another pharmacist; by
a pharmacist to a student-intern, extended-intern, or resident-intern;
or by a student-intern, extended-intern, or resident-intern to another
pharmacist.
(4) Both the original and the transferred prescription
drug orders are maintained for a period of two years from the date
of last refill.
(5) The individual transferring the prescription drug
order information shall ensure the following occurs:
(A) write the word "void" on the face of
the invalidated prescription or the prescription is voided in the
data processing system;
(B) record the name, address, if for a controlled substance,
the DEA registration number of the pharmacy to which it was transferred,
and the name of the receiving individual on the reverse of the invalidated
prescription or stored with the invalidated prescription drug order
in the data processing system;
(C) record the date of the transfer and the name of
the individual transferring the information; and
(D) if the prescription is transferred electronically,
provide the following information:
(i) date of original dispensing and prescription number;
(ii) number of refills remaining and if a controlled
substance, the date(s) and location(s) of previous refills;
(iii) name, address, and if a controlled substance,
the DEA registration number of the transferring pharmacy;
(iv) name of the individual transferring the prescription;
and
(v) if a controlled substance, name, address and DEA
registration number, and prescription number from the pharmacy that
originally dispensed the prescription, if different.
(6) The individual receiving the transferred prescription
drug order information shall:
(A) write the word "transfer" on the face
of the prescription or the prescription record indicates the prescription
was a transfer; and
(B) reduce to writing all of the information required
to be on a prescription as specified in subsection (b)(7) of this
section (relating to Prescriptions) and including the following information;
(i) date of issuance and prescription number;
(ii) original number of refills authorized on the original
prescription drug order;
(iii) date of original dispensing;
(iv) number of valid refills remaining and if a controlled
substance, date(s) and location(s) of previous refills;
(v) name, address, and if for a controlled substance,
the DEA registration number of the transferring pharmacy;
(vi) name of the individual transferring the prescription;
and
(vii) name, address, and if for a controlled substance,
the DEA registration number, of the pharmacy that originally dispensed
the prescription, if different; or
(C) if the prescription is transferred electronically,
create an electronic record for the prescription that includes the
receiving pharmacist's name and all of the information transferred
with the prescription including all of the information required to
be on a prescription as specified in subsection (b)(7) of this section
(relating to Prescriptions) and the following:
(i) date of original dispensing;
(ii) number of refills remaining and if a controlled
substance, the prescription number(s), date(s) and location(s) of
previous refills;
(iii) name, address, and if for a controlled substance,
the DEA registration number;
(iv) name of the individual transferring the prescription;
and
(v) name, address, and if for a controlled substance,
the DEA registration number, of the pharmacy that originally filled
the prescription.
(7) Both the individual transferring the prescription
and the individual receiving the prescription must engage in confirmation
of the prescription information by such means as:
(A) the transferring individual faxes the hard copy
prescription to the receiving individual; or
(B) the receiving individual repeats the verbal information
from the transferring individual and the transferring individual verbally
confirms that the repeated information is correct.
(8) Pharmacies transferring prescriptions electronically
shall comply with the following:
Cont'd... |
