Universal Pharmaceutical Waste

Transcription

1 Universal Pharmaceutical Waste NAHMMA May 2018

2 Pharmaceutical Waste in Florida Pharmaceutical waste in Florida may be managed in one of two ways: Hazardous waste pharmaceuticals may be managed as hazardous waste Subject to the same regulations as all other hazardous waste and counts toward generator status OR Hazardous waste pharmaceuticals may be managed as Universal Pharmaceutical Waste (UPW) Subject to Universal Waste rules and counts toward handler status BUT not toward generator status 7/4/2018 2

3 Universal Pharmaceutical Waste Rules Florida Administrative Code Applies to: Hazardous Waste Pharmaceuticals [defined in (4)(e), FAC] Large and Small Quantity Handlers of pharmaceutical waste Does not apply to: Pharmaceuticals that are not hazardous waste Pharmaceuticals that have not been discarded and are: Returned with reasonable expectation of credit Donated to a charitable organization Sold to persons who resell and do not discard pharmaceuticals Pharmaceuticals that are biomedical waste (but not hazardous) Spill residues, clean up materials, and media contaminated with pharmaceuticals related to a spill or discharge Raw materials and ingredients used in manufacture of pharmaceuticals 7/4/2018 3

4 Hazardous Waste Determination Facility must make a hazardous waste determination on all waste pharmaceuticals Determine if the pharmaceutical is a waste Determine if the pharmaceutical may be returned for credit through reverse distribution Determine if the pharmaceutical is a hazardous waste Determine if the pharmaceutical is bio-hazardous or is trace chemotherapy If the item is hazardous, it must be disposed of as hazardous, NOT as bio-hazardous or trace chemotherapy Only empty vials, lines, bags, PPE may be disposed of as trace chemotherapy [40 CFR ] 7/4/2018 4

5 Hazardous Waste Determination Determine if the pharmaceutical is listed P-list [40 CFR ] Acutely toxic waste U-list [40 CFR ] Determine if the pharmaceutical is characteristically hazardous Ignitable D001 [40 CFR ] Corrosive D002 [40 CFR ] Toxic D004 through D043 [40 CFR ] 7/4/2018 5

6 Determination Issues Pharmaceutical contains chemotherapy drug Example: half full bag of intravenous fluids containing chemotherapy agent, nonempty bottle of chemotherapy agent Item should be disposed of as hazardous waste NOT trace chemotherapy waste Pharmaceutical came into contact with human tissue, bodily fluid Example: half used syringe containing a hazardous waste pharmaceutical (certain vaccines) Item should be disposed of as hazardous waste NOT as bio-hazardous Pharmaceutical is hazardous waste and also a controlled substance Example: Diazepam injection, Chloral Hydrate, Demerol May reverse distribute 7/4/2018 6

7 Examples P-Listed Waste Nicotine Containing Products (P075) Warfarin >0.3% (P001) 7/4/2018 7

8 Examples U-Listed Waste Mitomycin (U010) Lindane (U129) Daunomycin (U059) Phenol-containing items (U188) Warfarin <0.3% (U248) 7/4/2018 8

9 Example Ignitable (D001) Waste Many drugs are ignitable in the injectable form Silver Nitrate Gel formulations with a flashpoint lower than 140 degrees F Items that contain greater than 24% alcohol 7/4/2018 9

10 Example Corrosive (D002) Waste Items that contain sodium hydroxide may be corrosive Items that contain acetic acid may be corrosive 7/4/

11 Example Toxic Waste D004 through D043 Items containing Cresol (D023 D026) Items containing arsenic (D004) Barium Sulfate contains heavy metal Barium (D005) Silvadene Creams and Ointments - contain heavy metal Silver (D011) Items containing Lindane (D013) 7/4/

12 Additional References References useful in making a hazardous waste determination American Hospital Formulary Service Remington s Pharmaceutical Sciences (available in print) Merck Manual The Pill Book Red Book Pharmacy Fundamental Reference (available in print) CRC Handbook of Chemistry and Physics (available in print) Drug Facts and Comparisons Plumb s Manual (veterinary reference) (available in print) Product MSDS EPA/FDEP websites EPA - DEP - Healthcare Environmental Resource Center (HERC) Website 7/4/

13 Reverse Distribution Hazardous Waste pharmaceuticals that may be returned for full or partial credit may be reverse distributed through a licensed reverse distributor Facility must have a reasonable expectation of credit (must be a viable item) If a shipment is refused by the reverse distributor, the facility must accept the shipment back and properly dispose of hazardous waste items Facility must make the hazardous waste determination, not the reverse distributor For example, the facility may not send ALL pharmaceuticals to reverse distributor for hazardous waste determination, only those for which the facility has a reasonable expectation of credit [ (7)(d), FAC] 7/4/

14 Large Quantity Handlers Large Quantity Handler Accumulates greater than 5,000 kg (11,000 lbs) of combined universal waste which includes some amount of pharmaceutical waste Accumulates greater than 1 kg (2.2 lbs) of acute hazardous waste at any one time (P-listed) Handler status is maintained until the end of the calendar year Accumulation time limit of six months from the date that the first item was placed into the container Required to apply for an EPA identification number [ (4)(f), FAC] 7/4/

15 Small Quantity Handlers Small Quantity Handler Accumulates less than 5,000 kg (11,000 lbs) of combined universal waste which includes some amount of pharmaceutical waste Accumulates less than 1 kg (2.2 lbs) of acute hazardous waste at any one time (P-listed) Accumulation time limit of one year from the time the first item was placed into the container Not required to apply for an EPA identification number (recent rule change) [ (4)(l), FAC] 7/4/

16 Container Requirements UPW must be managed in a way that prevents release Container should be closed (except when adding or removing waste) Container should lack evidence of leakage, spillage, or damage Compatible with the waste Improper Management Open Container 7/4/

17 Container Requirements Items may be individually packaged in container Facility may open container to sort waste, disassemble packaging, or remove outer packaging that does not come into contact with the pharmaceutical Releases must be immediately contained and perform a hazardous waste determination on all clean up materials (materials cannot be managed as UPW) Improper Management Open Container Container not labeled No indication of when accumulation began 7/4/

18 Container Labeling Container must be labeled Universal Pharmaceutical Waste or Universal Waste Pharmaceuticals Recommend dating with accumulation start date Recommend maintaining inventory of items placed into container Improper Management No indication of when accumulation began 7/4/

19 Common Containers Universal Pharmaceutical Waste is normally placed into a black bin that is labeled Universal Pharmaceutical Waste or Universal Waste Pharmaceuticals. No bio-hazardous or trace chemotherapy items should be placed in the UPW container unless they are considered hazardous waste. 7/4/

20 Common Containers Bio-hazardous waste items are normally placed in a red container that is marked as bio-hazardous. Hazardous waste or UPW items should not be placed into the bio-hazard container regardless of contact with human tissue or fluids. 7/4/

21 Common Containers Trace chemotherapy waste is normally placed into a yellow container that is marked as chemotherapy waste. Only trace items should be placed into this container (PPE, empty bottles). Hazardous waste or UPW items should not be placed into chemotherapy containers if they still contain chemotherapy drugs. 7/4/

22 Common Containers Containers for non-hazardous items in medical facilities are normally blue or white, but may be any color. No hazardous waste or UPW items should be placed in these containers. Non-hazardous pharmaceuticals that are not bio-hazardous or trace chemotherapy may be placed into non-hazardous containers. 7/4/

23 Accumulation Time Facility must demonstrate accumulation time May date the container May date each individual item May maintain an inventory system Other way of demonstrating accumulation start date UPW may be accumulated for up to: One year for SQH Six months for LQH [ (8), FAC] 7/4/

24 Training Requirements Any person working at a handler s facility must complete a training program within three months of hire Shall not manage UPW until training is completed Annual review of training Training must be documented [ (9), FAC] 7/4/

25 Shipments of UPW Must send shipments to a handler or reverse distributor who has notified the Department Should have EPA Identification number Written agreement to accept UPW Can cover multiple shipments Handler must provide adequate information about shipment to ensure safe handling and proper disposal Inventory list provided to transporter Waste codes on label Some other way to indicate what is in the shipment Facility must accept back any shipment that is refused by the designated facility [ (11), FAC] 7/4/

26 Record Keeping Handler must keep a record of all shipments of UPW sent to another handler, a reverse distributor, a destination facility, or a foreign destination May be a written receipt, bill of lading, disposal manifest, or other written document Should include legibly written: Name and address of handler Name and address of receiving handler, reverse distributor, destination facility, or foreign destination Quantity of UPW shipped Date of shipment Maintain records for a minimum of three years [ (12), FAC] 7/4/

27 Common Violations Failure to demonstrate accumulation time no date on container, no inventory system, no other tracking method (8)(d), FAC Open Containers containers should remain closed except when adding or removing waste (7)(a), FAC 7/4/

28 Common Violations Improperly disposing of hazardous waste items as bio-hazardous waste or trace chemotherapy waste 40 CFR /4/

29 Common Violations Failure to perform a hazardous waste determination just because you can eat it, doesn t mean it isn t hazardous! 7/4/

30 Common Violations Exceeding accumulation time limit LQH six months SQH one year (8)(a), FAC (8)(b), FAC 7/4/

31 Common Violations Re-dating accumulation container when new waste is added UPW rule does not allow satellite accumulation. 7/4/

32 Common Violations Unknown accumulation start date The container is not dated The facility did not maintain an inventory system No other means of indicating the accumulation start time (8)(d), FAC 7/4/

33 Common Violations Reverse distribution without reasonable expectation of credit (1)(b)(1), FAC 7/4/

34 Common Violations Failure to maintain adequate record of disposal (12), FAC Failure to perform adequate employee training (9), FAC 7/4/

35 Hazardous Waste Pharmaceutical Rule (Proposed by EPA) NAHMMA May 2018

36 Proposed Rule Federal Register published September 25, 2015 Management Standards for Hazardous Waste Pharmaceuticals Proposal is to add 40 CFR Part 266 Subpart P Part 266 includes Standards for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities 7/4/

37 Proposed Rule Goals of Proposed Rule Improve management and disposal of hazardous waste pharmaceuticals Clarify the regulatory status of Redistribution Reduce the amount of pharmaceuticals disposed down the drain Address overlap between EPA and DEA 7/4/

38 Proposed Rule Sewer Ban on disposal of listed or characteristic hazardous waste pharmaceuticals Proposal includes CESQG (VSQG) healthcare facilities not subject to the new rule Estimate that this will affect 145,000 facilities nationwide 7/4/

39 Requirements Notification Required for all generators of hazardous waste pharmaceuticals except VSQG regardless of previous notifications Training Training requirement similar to SQG standards LQG s can continue to use existing training Waste Determination Determine if waste is listed or characteristic but do not need to monitor EPA waste codes

40 Requirements Container Standards Structurally sound Compatible with waste Secured to prevent unauthorized access Labeling Hazardous Waste Pharmaceutical Accumulation Time Limit One year time limit Mark on label Maintain in inventory Any other method that tracks accumulation time

41 Requirements Off-Site Shipments Hazardous waste manifest required Shipped to RCRA TSD Reporting Requirements Exception reporting for manifest not returned in 60 days similar to existing SQG requirements Pharmaceuticals will not be included on Biennial Report Record Keeping Signed Copies of manifests retained for 3 years Waste determinations, test results, etc. kept for 3 years

42 Requirements Long-Term Care Facilities Propose to eliminate household hazardous waste exemption Must collect hazardous waste pharmaceuticals living within the facility and manage them according to Subpart P No disposal of hazardous waste pharmaceuticals down drain

43 Requirements Reverse Distribution Hazardous waste determination must be made on pharmaceuticals destined for reverse distribution No set accumulation time limit, container management, or labeling requirements WHY? Usually in original container as well as outer packaging Typically generated in a pharmacy area where access is restricted Items usually shipped off-site promptly for credit

44 Requirements Conditional Exemption for Hazardous Waste Pharmaceuticals that are also DEA Controlled Substances Examples: Chloral; Chloral Hydrate Sedative, U034 Toxic, found in Pediatric Units and Vet Anesthetic Fentanyl Sublingual Spray Analgesic, D001 Ignitable, Alcohol Content Phenobarbital Anticonvulsant, D001 Ignitable, Alcohol Content Testosterone Gels Hormone, D001 Ignitable, Alcohol Content Valium Injectable Anti-anxiety, D001 Ignitable, Alcohol Content

45 Requirements Proposal is to conditionally exempt hazardous wastes that are also DEA controlled substances provided: Waste is combusted in a RCRA permitted incinerator or cement kiln or in a permitted municipal waste combustor Waste is managed and disposed of in accordance with DEA regulations for controlled substances

46 Requirements Residuals in Pharmaceutical Containers - Proposals for addressing 3 types of containers (1) Unit Dose Containers packets, cups, wrappers, blister packs, and delivery devices up to 1 Liter If fully dispensed then non-hazardous, including P-List Drugs (2) Dispensed Syringes If fully dispensed then can go in sharps container as non-hazardous (3) Other containers, including delivery devices (IV bags, tubing, etc.) Residues would be regulated as hazardous waste due to volume remaining and potential for emptying into a sink. Would be regulated under Part 266 Subpart P

47 Requirements Significant requirements for Reverse Distributors in proposed rule

48 Questions?