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

Current through Reg. 50, No. 138; July 16, 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.