Florida Administrative Code
64 - DEPARTMENT OF HEALTH
64B16 - Board of Pharmacy
Chapter 64B16-28 - GENERAL REQUIREMENTS - PERMITS
Section 64B16-28.140 - Record Maintenance Systems for All Pharmacy Permits
Universal Citation: FL Admin Code R 64B16-28.140
Current through Reg. 50, No. 187; September 24, 2024
(1) Requirements for records maintained in a data processing system.
(a) The pharmacy must
comply with the provisions of
21 C.F.R. Section
1304.04 (a regulation of the Federal Drug
Enforcement Administration), which is hereby incorporated by reference as of
June 28, 2021, and available at
http://www.flrules.org/Gateway/reference.asp?No=15499
when such is applicable to operate such a data processing system if any
controlled substances (as that term is used in Chapter 893, F.S.) are dispensed
from the pharmacy.
(b) Any pharmacy
using a data processing system must meet the requirements of
21 C.F.R. Section
1306.22, which is hereby incorporated by
reference as of March 31, 2010 and available at
http://www.flrules.org/Gateway/reference.asp?No=15500.
(c) If a pharmacy's data processing system is
not in compliance with this subsection, the pharmacy must maintain a manual
recordkeeping system as specified in Rule
64B16-27.800, F.A.C., and
Section 893.07, F.S.
(d) Original prescriptions, not received in
written form shall be reduced to writing or recorded electronically if
permitted by federal law. All original prescriptions shall be retained for a
period of not less than four (4) years from date of last filling. To the extent
authorized by 21 C.F.R.
§
1304.04, a pharmacy may, in lieu of
retaining the actual original prescriptions, use an electronic imaging
recordkeeping system, provided such system is capable of capturing, storing,
and reproducing the exact image of the prescription, including the reverse side
of the prescription if necessary, and that such image be retained for a period
of no less than four (4) years from the date of last filling.
(e) Original prescriptions shall be
maintained in a two or three file system as specified in
21 C.F.R. §
1304.04(h).
(f) Requirements for back-up systems.
1. The pharmacy shall maintain a back-up copy
of information stored in the data processing system using disk, tape or other
electronic back-up system and update this back-up copy on a regular basis, at
least weekly, to assure that data is not lost due to system failure.
2. Data processing systems shall have a
workable (electronic) data retention system which can produce an audit trail of
drug usage for the preceding four (4) years as specified in Rule
64B16-27.800,
F.A.C.
(g) Change or
discontinuance of a data processing system.
1.
Records of dispensing. A pharmacy that changes or discontinues use of a data
processing system must:
a. Transfer the
records of dispensing to the new data processing system, or
b. Purge the records of dispensing to a
printout which contains the same information required on the daily printout as
specified in paragraph (3)(b), of this section. The information on this
hard-copy printout shall be sorted and printed by prescription number and list
each dispensing for this prescription chronologically.
2. Other records. A pharmacy that changes or
discontinues use of a data processing system must:
a. Transfer the records to the new data
processing system; or
b. Purge the
records to a printout which contains all of the information required on the
original document.
3.
Maintenance of purged records. Information purged from a data processing system
must be maintained by the pharmacy for four (4) years from the date of initial
entry into the data processing system.
(h) Loss of Data. The prescription department
manager shall report to the Board in writing any loss of information from the
data processing system within 10 days of discovery of the
loss.
(2) All transfers of prescriptions must be strictly in accordance with the provisions of Section 465.026, F.S.
(3) Records of dispensing.
(a) Each time a prescription drug order is
filled or refilled, a record of such dispensing shall be entered into the data
processing system.
(b) The data
processing system shall have the capacity to produce a daily hard-copy printout
of all original prescriptions dispensed and refilled. This hard copy printout
shall contain the following information:
1.
Unique identification number of the prescription;
2. Date of dispensing;
3. Patient name;
4. Prescribing practitioner's name;
5. Name and strength of the drug product
actually dispensed, if generic name, the brand name or manufacturer of drug
dispensed;
6. Quantity
dispensed;
7. Initials or an
identification code of the dispensing pharmacist; and,
8. If not immediately retrievable via CRT
display, the following shall also be included on the hard-copy printout:
a. Patient's address;
b. Prescribing practitioner's
address;
c. Practitioner's DEA
registration number, if the prescription drug order is for a controlled
substance;
d. Quantity prescribed,
if different from the quantity dispensed;
e. Date of issuance of the prescription drug
order, if different from the date of dispensing; and,
f. Total number of refills dispensed to date
for that prescription drug order.
(c) The daily hard-copy printout shall be
produced within 72 hours of the date on which the prescription drug orders were
dispensed and shall be maintained in a separate file at the pharmacy. Records
of controlled substances shall be readily retrievable from records of
non-controlled substances.
(d) Each
individual pharmacist who dispenses or refills a prescription drug order shall
verify that the data indicated on the daily hard-copy printout is correct, by
dating and signing such document in the same manner as signing a check or legal
document (e.g., J.H. Smith, or John H. Smith) within seven days from the date
of dispensing.
(e) In lieu of
producing the printout described in paragraphs (b) and (c) of this section, 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 four (4)
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 Department of Health. If no printer is available on site, the hard-copy
printout shall be available within 48 hours with a certification by the
individual providing the printout, which states that the printout is true and
correct as of the date of entry and such information has not been altered,
amended or modified.
(f) The
prescription department manager and the permit holder are 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.
(g) Failure to provide the records set out in
this section, either on site or within 48 hours for whatever reason,
constitutes failure to keep and maintain records.
(h) In the event that a pharmacy which uses a
data processing system experiences system downtime, the following is
applicable;
1. 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 that authorization
from the prescribing practitioner has been obtained prior to dispensing a
refill; and,
2. All of the
appropriate data shall be retained for online data entry as soon as the system
is available for use again.
(4) Compounding records. A written record shall be maintained for each batch/sub-batch of a compounded product under the provisions of Rule 64B16-27.700, F.A.C. This record shall include:
(a) Date of
compounding.
(b) Control number for
each batch/sub-batch of a compounded product. This may be the manufacture's lot
number or new numbers assigned by the pharmacist. If the number is assigned by
the pharmacist, the pharmacist shall also record the original manufacture's lot
number and expiration dates. If the original numbers and expiration dates are
not known, the pharmacy shall record the source and acquisition date of the
component.
(c) A complete formula
for the compounded product maintained in a readily retrievable form including
methodology and necessary equipment.
(d) A signature or initials of the pharmacist
or pharmacy technician performing the compounding.
(e) A signature or initials of the pharmacist
responsible for supervising pharmacy technicians involved in the compounding
process.
(f) The name(s) of the
manufacturer(s) of the raw materials used.
(g) The quantity in units of finished
products or grams of raw materials.
(h) The package size and number of units
prepared.
(i) The name of the
patient who received the particular compounded product.
(5) Authorization of additional refills. Practitioner authorization for additional refills of a prescription drug order shall be noted as follows:
(a) On the daily
hard-copy printout; or
(b) Via the
CRT display.
(6) Any other records, policy and procedure manuals, or reference materials which are not specifically required by statute or rule to be kept in a hard copy may be kept in a readily retrievable data processing system which complies with the provisions of subparagraph (1)(f)1.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.022, 465.026, 465.035, 893.07 FS.
New 3-16-94, Formerly 61F10-28.140, Amended 3-12-97, 6-4-97, Formerly 59X-28.140, Amended 10-29-97, 6-15-98, 11-11-98, 10-15-01, 3-24-14, 7-9-23.
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