At its meeting held on February 12, 2014, the Florida Board of Pharmacy voted to approve language changes to a number of rules. Specifically, those changes were put into effect to establish a uniform four-year retention policy for pharmacy records.
Previously the Board’s rules were not consistent with respect to how long pharmacies were required to retain different types of records.
When approving new rules or changes to existing rules, administrative bodies are required to evaluate the regulatory costs of the changes. In examining these costs the Board found that any financial costs imposed upon small businesses would be balanced by the efficiencies created by a uniform retention period.
Board of Pharmacy Voted to Change the Wording in These Rules.
Below is a list of the administrative rules that were changed:
– Standards for the Approval of Registered Pharmacy Technician Training Programs
Rule 64B16-26.351, Florida Administrative Code
– Standards for Approval of Courses and Providers
Rule 64B16-26.601, Florida Administrative Code
– Continuing Education Records Requirements
Rule 64B16-26.603, Florida Administrative Code
– General Terms and Conditions to be Followed by a Pharmacist When Ordering and Dispensing Approved Medicinal Drug Products
Rule 64B16-27.210, Florida Administrative Code
– Standards of Practice – Continuous Quality Improvement Program
Rule 64B16-27.300, Florida Administrative Code
– Requirement for Patient Records
Rule 64B16-27.800, Florida Administrative Code
– Change of Ownership
Rule 64B16-28.2021, Florida Administrative Code
– Centralized Prescription Filling, Delivering and Returning
Rule 64B16-28.450, Florida Administrative Code
– Transmission of Starter Dose Prescriptions for Patients in Class I Institutional or Modified II B Facilities
Rule 64B16-28.503, Florida Administrative Code
– Class II Institutional Pharmacies
Rule 64B16-28.605, Florida Administrative Code
– Remote Medication Order Processing for Class II Institutional Pharmacies
Rule 64B16-28.606, Florida Administrative Code
– Automated Pharmacy System – Long-Term Care, hospice, and Prison
Rule 64B16-28.607, Florida Administrative Code
– Modified Class II Institutional Pharmacies
Rule 64B16-28.702, Florida Administrative Code
– Record Maintenance for Animal Shelter Permits
Rule 64B16-29.0041, Florida Administrative Code
Make Sure Your Facility is Prepared.
While these rule changes are not final, it is important to recognize if they will be affecting your facility. You should also be making arrangements in your facility to ensure that there is enough computer disk space or physical space to retain these records. Keep in mind that these records retention rules are in addition to any others imposed by other Florida or federal statutes or rules relating to controlled substances or other pharmacy practices.
Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.
The Health Law Firm represents pharmacists and pharmacies in DEA investigations, regulatory matters, licensing issues, litigation, administrative hearings, inspections and audits. The firm’s attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.
To contact The Health Law Firm please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.
How do you feel about the requirement of pharmacy records to be retained for four years? Please leave any thoughtful comments below.
About the Author: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.
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