64B16-28.140. Record Maintenance Systems for All Pharmacy Permits

(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. History–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.