Variance and Waiver from Edwin Bayo, General Counsel on behalf of CVS Vero FL Distribution, L.L.C., and CVS Orlando FL Distribution, L.L.C., filed on February 27, 2013. The petition seeks a variance and waiver of its administrative rules of 61N-...

 

DEPARTMENT OF BUSINESS AND PROFESSIONAL REGULATION
Drugs, Devices and Cosmetics

NOTICE IS HEREBY GIVEN that on February 27, 2013, the Division of Drugs, Devices and Cosmetics, received a petition for Variance and Waiver from Edwin Bayo, General Counsel on behalf of CVS Vero FL Distribution, L.L.C., and CVS Orlando FL Distribution, L.L.C., filed on February 27, 2013.
The petition seeks a variance and waiver of its administrative rules of paragraph 61N-1.012(2)(e); paragraph 61N-1.013(3)(c); and subparagraph 61N-1.013(5)(d).a., F.A.C.
61N-1.012 Records of Drugs, Cosmetics and Devices.
(2) Any person engaged in the manufacture of prescription drugs, the wholesale distribution of prescription drugs, or otherwise receiving or distributing prescription drugs must maintain records as follows:
(e) Inventory. A complete and accurate record of all stock of prescription drugs on hand must be made annually by establishments permitted under Chapter 499, F.S. A physical inventory must be conducted at least annually unless perpetual inventory records are maintained, in which case the physical inventory may be conducted on a biennial basis. Significant inventory discrepancies must be investigated and handled in accordance with written policies and procedures of the establishment. In addition, no later than July 17, 2006, each wholesale distributor shall submit to the department an inventory of drugs it has on hand as of June 30, 2006.
61N-1.013 Prescription Drugs; Receipt, Storage and Security.
(3)(c) A record must be maintained recording the date; time; thermometer one temperature; thermometer two temperature; and the initials of the person recording the data or reviewing the data if electronically monitored. This record and temperature reading must be recorded at least five (5) days each week with the temperature readings taken between 2:00 p.m. and 4:00 p.m. E.S.T. Alternate times may be approved by the department in writing. This record must be kept on file by the facility for at least two years.
61N-1.013 Prescription Drugs; Receipt, Storage and Security.
(5) Examination of Prescription Drugs; Physical Product and Records.
(d) Authentication.
a. Receipt of an invoice (or shipping document) from the seller to the purchaser, which may have the prices redacted. Documentation requirements include at a minimum a copy of the invoice or shipping document. If this method is used to authenticate a pedigree, the wholesaler must review the document received for signs of tampering, incompleteness, or inconsistency with other invoices or shipping documents from that manufacturer or wholesaler, and must randomly verify the authenticity of the invoice or shipping document with the seller or shipping point reflected on that document using one of the methods in sub-subparagraph b., c., or d. below. Each wholesaler shall establish and adhere to policies and procedures for the random verification of the authenticity of the invoices or shipping documents according to statistically valid standards.
A copy of the Petition for Variance or Waiver may be obtained by contacting: The Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047
Please refer all comments to: Reggie Dixon, Executive Director, Division of Drugs, Devices and Cosmetics, 1940 N. Monroe Street, Suite 26A, Tallahassee, FL 32399-1047; website: http://interredesignalpha/dbpr/ddc/ddc_division_notices.html.