Compliance Assurance

Universal Pharmaceutical

Waste

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Why Should I Care About Pharmaceutical Waste?

• Hazardous waste pharmaceuticals disposed of improperly:– May contaminate soil or seep into groundwater contaminating drinking water supply– May run off into nearest body of water and poison or kill fish and other wildlife– May pose a risk to your health, employee health, and the community

• Cost Savings– State and county environmental compliance inspectors may conduct inspections– Fines can be up to $50,000 per day per violation

• Public Image– Customers appreciate commitment to the environment and to prevent pollution– Good neighbor

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Proper Pharmaceutical Management

• Recommendations for General Pharmaceutical Management– Conduct random pharmaceutical audits and remove expired products– Do not accept pharmaceutical samples that may not be used before the expiration date– Designate an area for the accumulation of outdated pharmaceuticals– Designate an area for items that are waste pharmaceuticals– Do not discharge waste into sinks or other drains without written permission from the

Publically Owned Treatment Works (POTW)– Do not discharge into septic tanks– Do not mix hazardous waste pharmaceuticals with bio-hazardous or trace

chemotherapy waste– Thoroughly train employees of management practices– Dispensing systems provide ease of use and strict inventory control

• Pyxis• ScriptPro• Cubex

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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

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Universal Pharmaceutical Waste Rules

• Florida Administrative Code 62-730.186

• Applies to • Hazardous Waste Pharmaceuticals [defined in 62-730.186(4)(e)]• Large and Small Quantity Handlers of pharmaceutical waste

• Does not apply to [62-730.186(2)]:• 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

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Hazardous Waste Determination

• Facility must make a hazardous waste determination on all waste pharmaceuticals (40 CFR 262.11)– Determine if the pharmaceutical is a waste

• Can the pharmaceutical be used again?– Example: multi-dose vials such as insulin

• If it can be used again, it is not a waste

– Determine if the pharmaceutical may be returned for credit through reverse distribution

• Is the item expired or overstock?• Is the packaging damaged?

– Determine if the pharmaceutical is a hazardous waste• Formulary review, MSDS review, analytical testing

– 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

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Hazardous Waste Determination

• Determine if the pharmaceutical is listed– P-list (40 CFR 261.33) – Acutely toxic waste– U-list (40 CFR 261.33)

• Determine if the pharmaceutical is characteristically hazardous– Ignitable – D001 (40 CFR 261.21)– Corrosive – D002 (40 CFR 261.22)– Toxic – D004 through D043 (40 CFR 261.24)

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Determination Issues

• Pharmaceutical contains chemotherapy drug– Example: half full bag of intravenous fluids containing chemotherapy agent, non-empty

bottle of chemotherapy agent– Item should be dispose 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

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Examples P-Listed Waste

Nicotine Containing Products (P075)

Warfarin >0.3% (P001)

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Examples U-Listed Waste

Mitomycin (U010)

Daunomycin (U059)

Lindane (U129)

Phenol-containing items (U188)

Warfarin <0.3% (U248)

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Example Ignitable (D001) Waste

Many drugs are ignitable in the injection form

Silver Nitrate Gel formulations with a flashpoint lower than 140 degrees F

Items that contain greater than 24% alcohol

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Example Corrosive (D002) Waste

Items that contain sodium hydroxide may be corrosive

Items that contain acetic acid may be corrosive

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Example Toxic Waste• D004 through D043

Barium Sulfate – contains heavy metal Barium (D005)

Usually only in concentrations of 200% Silvadene Creams and

Ointments - contain heavy metal Silver (D011)

Items containing arsenic (D004)

Items containing Lindane (D013)

Items containing Cresol (D023 – D026)

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Additional References• References useful in making a hazardous waste determination

– American Hospital Formulary Service • http://www.ahfsdruginformation.com/

– Remington’s Pharmaceutical Sciences (available in print)

– Merck Manual • http://www.merckmanuals.com/professional/index.html

– The Pill Book • http://www.drugs.com/pill_identification.html

– Red Book – Pharmacy Fundamental Reference (available in print)

– CRC Handbook of Chemistry and Physics (available in print)

– Drug Facts and Comparisons• http://www.drugs.com/ppa/

– Plumb’s Manual (veterinary reference) (available in print)

– Product MSDS– EPA/FDEP websites

• EPA - http://www.epa.gov/waste/hazard/generation/pharmaceuticals.htm• DEP - http://www.dep.state.fl.us/waste/pharm/

– Healthcare Environmental Resource Center (HERC) Website• http://www.hercenter.org/hazmat/hazdeterm.cfm

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Reverse Distribution

• 62-730.186(7)(d)

• 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

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Handler Requirements

• 62-730.186(7)(b)

• Hazardous waste pharmaceuticals for which the facility has no reasonable expectation of credit, may be managed as UPW rather than as hazardous waste

• Requirements are similar to those of other Universal Waste such as batteries or spent mercury-containing lamps

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Large Quantity Handlers

• Large Quantity Handler 62-730.186(4)(f)– 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

• http://www.dep.state.fl.us/waste/quick_topics/forms/documents/62-730/730_1b.pdf

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Small Quantity Handlers

• Small Quantity Handler 62-730.186(4)(l)– 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)

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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– 62-730.186(7)(a)

Improper Management

•Open Container

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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

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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

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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.

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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.

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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.

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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.

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Accumulation Time

• Facility must demonstrate accumulation time 62-730.186(8)– 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

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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• 62-730.186(9)

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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

• 62-730.186(11)

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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

• 62-730.186(12)

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Common Violations

Open Containers – containers should remain closed except when adding or removing waste

62-730.186(7)(a)

Failure to demonstrate accumulation time – no date on container, no inventory system, no other tracking method

62-730.186(8)(d)

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Common Violations

Improperly disposing of hazardous waste items as bio-hazardous waste or trace chemotherapy waste

40 CFR 262.11

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Common Violations

Failure to perform a hazardous waste determination – just because you can eat it, doesn’t mean it isn’t hazardous!

40 CFR 262.11

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Common Violations

Exceeding accumulation time limit

•LQH – six months•SQH – one year

62-730.186(8)(a)62-730.186(8)(b)

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Common Violations

Re-dating accumulation container when new waste is added

UPW rule does not allow “satellite” accumulation

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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

62-730.186(8)(d)

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Common Violations

Reverse distribution without reasonable expectation of credit

62-730.186(1)(b)(1)

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Common Violations

• Failure to maintain adequate record of disposal– 62-730.186(12)

• Failure to perform adequate employee training– 62-730.186(9)

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Questions?

Compliance Assurance Group

Northeast District

8800 Baymeadows Way West, Suite 100

Jacksonville, Florida