1. Universal Pharmaceutical Waste (UPW) Training

2. UPW Training Requirements (62-730.186(9) Florida Administrative Code)
(9) A handler shall ensure that all employees handling or managing universal pharmaceutical waste successfully complete a program of classroom instruction or on-the-job training.
(a) The training shall ensure that all employees are thoroughly familiar with proper waste management procedures relevant to their responsibilities during normal facility operations and emergencies. The training shall include response to releases as required by subsection (10), F.A.C.

3. UPW Training Requirements (62-730.186(9) Florida Administrative Code)
(b) Employees working at a handler’s facility on April 22, 2007 shall successfully complete the training program required in paragraph (9)(a), F.A.C., within three months after the effective date. Employees hired or assigned after April 22, 2007 shall successfully complete the training program within three months after the date of their employment at or assignment to the handler’s facility. These employees shall not manage universal pharmaceutical waste unsupervised until they have completed the training requirements.

4. UPW Training Requirements (62-730.186(9) Florida Administrative Code)
(c) Employees shall take part in an annual review of the initial training required in paragraph (9)(a), F.A.C., and the handler shall ensure that the annual review is available to the employees.
(d) A handler shall document the training given to each employee. The documents shall include the employee’s name, signature, date of hire or assignment, date of training, and type of training. The training documents shall be kept at the handler’s place of business for at least three years.

5. Overview Hazardous Waste Pharmaceutical Waste Universal Waste
Universal Pharmaceutical Waste
Accumulation
Labeling
Storage
Response to Releases

6. Hazardous Waste Resource Recover Conservation Act (RCRA)
Established in 1976
Regulates management and disposal of hazardous chemicals
Hazardous Waste Determination
Listed (P&U List)
Characteristic (Toxic, Flammable, Corrosive, Reactive)

7. Pharmaceutical Waste
“Pharmaceutical” means a manufactured chemical product that is intended to be inhaled, ingested, injected, or topically applied for use in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease or injury in humans or other animals. ( (4)(h)

8. Pharmaceutical Waste
“Non-viable” means a pharmaceutical that cannot be sold, returned to the manufacturer, wholesaler or reverse distributor with a reasonable expectation of credit, or donated to a charitable organization. Pharmaceuticals that are obviously “waste-like”, such as partial intravenous formulations; partial vials used in the preparation of intravenous (IV) formulations; outdated samples; other outdated items repackaged at the pharmacy; partial vials or vials used on the unit and not emptied (such as insulin and epinephrine dispensing devices); partial ointments, creams and lotions; partial inhalants; partial containers that are not empty; patient’s personal medications that have been left at the hospital; filled finished products that are rejected during the manufacturing process, so long as they are in their consumer package (such as bottle, jar, tube, or ampule), do not support a reasonable expectation of credit and therefore are non-viable pharmaceuticals. ( (4)(i)F.A.C.)

9. Pharmaceutical Waste
“Hazardous waste pharmaceutical” means a “non-viable” “pharmaceutical” that exhibits a characteristic or is listed hazardous waste. If the waste formulation includes a listed commercial chemical product as the sole active ingredient, then the entire formulation is considered a hazardous waste pharmaceutical, unless excluded by regulation. A pharmaceutical becomes a waste when it is no longer “viable”; when a decision is made to discard the pharmaceutical; or when the pharmaceutical is abandoned. A pharmaceutical does not meet the definition of a “solid waste” and is considered product as long as it is viable, a decision to discard it has not been made, and it is not abandoned. Pharmaceuticals that are produced by a pharmaceutical manufacturer without reasonable expectation of sale, returned or delivered without a reasonable expectation of credit to a manufacturer, wholesaler, reverse distributor or any type of waste broker, are non-viable and are discarded. Once a decision has been made to discard a viable pharmaceutical, it becomes non-viable. Non-viable pharmaceuticals that are hazardous waste may be handled as universal waste under this rule. ( (4)(i)F.A.C.)

10. Universal Waste Mercury Containing Devices Fluorescent Lamps Batteries
Electronic Devices
Pharmaceuticals (Florida & Michigan)
Universal Waste must first be regulated under RCRA before it is considered for regulation under universal waste guidelines.

11. Florida’s Universal Pharmaceutical Waste (UPW) Regulation
Florida Administrative Code (FAC)
April 22nd 2007
“Hazardous waste pharmaceuticals are considered to be universal waste in Florida when managed in accordance with this section.” ( (3), F.A.C.)
Hereafter referred to as “UPW”

12. Where is UPW going now? In the “red bag” – autoclaved and landfilled
Down the drain – defeats water & sewer treatment
In the landfill – leaches into groundwater
Adversely impacts air emissions, water resources, fish, wildlife and human health.

13. What is the Difference?
What is the difference between “Biomedical waste” and “Waste Pharmaceuticals?”
Biomedical waste – Any solid or liquid waste which may present a threat of infection to humans, including nonliquid tissue, body parts, blood, blood products, and body fluids from humans and other primates; laboratory and veterinary wastes which contain human disease-causing agents; and discarded sharps. The following are also included:
(a) Used, absorbent materials saturated with blood, blood products, body fluids, or excretions or secretions contaminated with visible blood; and absorbent materials saturated with blood or blood products that have dried.
(b) Non-absorbent, disposable devices that have been contaminated with blood, body fluids or, secretions or excretions visibly contaminated with blood, but have not been treated by an approved method.

14. What about “Dual Waste”?
Biomedical Waste mixed with Hazardous Waste:
64E Facility Policies and Procedures.
(1) All biomedical waste facilities shall comply with the following:
(a) Biomedical waste mixed with hazardous waste, as defined in Chapter , F.A.C., Hazardous Waste, shall be managed as hazardous waste.

15. Accumulation Yellow 18 gallon container
Obtain from Environmental Services
Containers MUST REMAIN CLOSED except when adding or removing UPW.
Must not show evidence of leakage under reasonably foreseeable conditions.
Contact Environmental Services if container is full or shows evidence of leakage.

16. Labeling Accumulation containers must be labeled.
Obtain labels from Environmental Services if not pre-labeled
Date label upon use
Must be legible

17. Storage Location Satellite accumulation area
Restricted area (authorized personnel only)
Keep container closed unless adding or removing waste
Do not overfill container
Call Environmental Services when full

18. Spills
A handler shall immediately contain all releases of universal pharmaceutical waste.
A handler shall determine whether any material resulting from a release is hazardous waste.
Material resulting from the release of universal pharmaceutical waste may not be managed as universal pharmaceutical waste (10)

19. Spills Incidental Spills Clean up spilled material and contain
Contact Environmental Services
Material must be managed as hazardous waste

20. Major Spills Follow facility protocols for major spills
Isolate and evacuate immediate area
Contact Environmental Services

21. Do’s & Don’ts Do’s Don’t Label and date when accumulation begins
Keep closed unless adding or removing UPW
Keep in a restricted area away from public
Prevent spills, keep upright, do not overfill
Don’t
Place biomedical waste in UPW container
Place controlled substances in UPW container
Place regular trash in the UPW container
Do not leave unsecured, or unsupervised if unsecured

22. There are no stupid questions… …Or stupid answers