[Pharmwaste] Inventorying of pharmaceutical waste in Florida
hws4 at comcast.net
Fri Oct 30 05:56:45 EDT 2009
Looking for some guidance, especially from hospitals/facilities disposing of Pharmaceutical waste in the State of Florida.
Per the copy of the email below the Florida Dept. of Health Drugs, Devices and Cosmetics Division requires that all Prescription Pharmaceuticals leaving the hospital/Facility be inventoried, etc. My question to this agency was does that apply to Hazardous Waste Pharmaceuticals generated in numerous areas of the hospital (OR, ER ICU, Patient Rooms, Med Rooms, etc) and include but are not limited to : Partially used Vials, ampoules, Syringes with needles, IV Bags, pills (Potentially some that may be contaminated with blood also).
I am not interpreting their regulations but have attached the response below.
I am asking for guidance from any facility out there who inventories every Hazardous or Non Hazardous Prescription Pharmaceutical before its placed into a black, yellow, white or whatever color your facility is using to dispose of your non-viable pharmaceutical waste.
I would appreciate any assistance so I can share with other facilities around the state.
Dear Mr. Stewart:
Thank you for contacting the Florida Department of Health regarding compliance with Florida's prescription drug distribution laws and regulations.
You have raised several issues in your email. First and foremost, I am not an attorney and cannot provide you with legal advice. Please be aware that any efforts to assist you with navigating the Department's laws and rules does not constitute Department action and, thus, is not a defense against any present or future violations found by the Florida Department of Health. May I direct you to the rule that currently addresses records that are required to be maintained by pharmacies prior to the prescription drugs leaving the premise, which is Chapter 64F-12.012, Florida Administrative Code, subsection (2)(d) Records of Drugs, Cosmetics and Devices, provided below.
(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:
(d) Records to document the distribution of prescription drugs required by Section 499.0121(6), F.S., and this rule are to be created during the transaction (i.e., at the time of order, receipt, processing, picking or shipping) and not retroactively created. A pharmacy or other person authorized to possess prescription drugs that transfers prescription drugs to an establishment performing reverse distribution services or destruction activities must prepare or have prepared an inventory or other record of the prescription drugs so transferred prior to the prescription drugs leaving the premises. In addition to the name, address, and license number of the sender and the name, address, and license number of the receiving establishment, the record must include the elements set forth in paragraph 64F-12.023(3)(a), F.A.C.
Unfortunately, I am unable to provide you with the specific answers to your questions, as they require an opinion from the Department of Health. The process for seeking a formal opinion from the Department regarding the application of Florida laws to your specific set of facts is governed by section 120.565, Florida Statutes, and Rule 28-105, Florida Administrative Code which deals with petitions for declaratory statements.
I hope this information is beneficial to you.
Gregg Jones, RPh
Florida Department of Health
MQA Board of Pharmacy/Drugs, Devices, and Cosmetics
4052 Bald Cypress Way, C-04
Tallahassee, FL 32399
850-245-4737 - Phone 850-413-6982 - Fax
gregg_jones at doh.state.fl.us www.doh.state.fl.us/mqa/ddc
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Please note: Florida has a very broad public records law. Most written communications to or from state officials regarding state business are public records available to the public and media upon request. Your e-mail communications may therefore be subject to public disclosure.
Barry E. Stewart
Training Coordinator/ Regional Project Manager
418 Cypress Road
Ocala, FL 34472
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