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William Kappler
Environmental Specialist
Hazardous Waste Section
(407) 893-3323
[email protected]
Topics
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Potential Pharmaceutical characteristics and listings.
When pharmaceuticals become waste.
General pharmaceutical management.
Definitions
Function of a reverse distributor - Reverse distributor scenarios
(who becomes the generator).
Pharmaceuticals
Potential Characteristics
 Most Frequent is: Characteristic of Ignitability
 Liquids which exhibit a flash point less than 140 degrees F. and
include aqueous mixtures containing an alcohol concentration of
24% or higher.
 Non-liquid and is capable of causing fire through friction,
absorption of moisture, or spontaneous chemical changes.
 Oxidizer - peroxide, chlorate, and nitrate.
 Ignitable compressed gas.
 Designated by the identification code D001.
Ammonia & Alcohol
 Pharmaceutical
preparations include
rubbing alcohol,
anesthetic, flexible
collodion, coal tar
solution, tinctures,
and spirits.
 Aerosols containing
flammable
propellants.
Ethyl Chloride
 Topical
anesthetic
Potential Characteristics
 Characteristic of Corrosivity
 It is aqueous having a pH less than or equal to 2 or greater than or
equal to 12.5.
 Designated by the identification code D002.
Acids & Caustics
 Glacial Acetic, Tannic,
Phosphoric, Sulfuric,
Nitric, & Hydrochloric
acids.
 Sodium Hydroxide.
Hydrogen Peroxide
 3% solution has
pH of 3 to 4.
 50% solution
has pH of 1.
Potential Characteristics
 Characteristic of Reactivity
 Wastes which are unstable, react violently with water, or capable of
detonation when heated under confinement.
 Designated by the identification code D003.
Clinitest
 Reagent tablet for
urine sugar testing.
 Ingredients: copper
sulfate, sodium
hydroxide, sodium
carbonate, and citric
acid. Possibly
corrosive and
reactive. Tablet
highly sensitive to
moisture, excessive
moisture may cause
a chemical reaction.
Potential Characteristics
 Characteristic of Toxicity
 Determined by a method which analyzes toxic constituents in the
waste sample.
 Designated by the identification code D004 - D043.
 Maximum concentration of contaminants (mercury - 0.2 mg/L,
silver - 5 mg/L, selenium - 1 mg/L, barium - 100 mg/L, chromium 5 mg/L lindane - 0.4 mg/L, chloroform - 6 mg/L, cresol - 200 mg/L).
Silver Nitrate Sticks
 Contains silver
also possible
oxidizer.
Human and Animal Vaccine
 Mercury as a
preservative.
Potential Listing
 Acute Listing
 Capable of causing or significantly contributing to an increase in
serious irreversible, or incapacitating reversible illness.
 Commercial chemical product consists of a sole active
ingredient.
 Designated by a P code.
Epinephrine/Adrenaline
 An acute
hazardous waste
if the sole active
ingredient.
 >1 kg (2.2 LB).
NitroQuick
 Dosage forms
include sterile
solutions,
tablet, oral
spray, patch,
and ointment.
Nitroglycerin
 Patch.
 Nitro-Dur, and
Nitrodisc.
Nicotine
 Sold in patch,
spray or
chewing gum
form.
Warfarin or Coumadin
 When concentration
is greater than 0.3%.
Acute waste.
 When concentration
is 0.3 % or less. Toxic
waste.
Potential Listing
 Toxic Listing
 Demonstrate in scientific studies it has toxic, carcinogenic,
mutagenic, or teratogenic effect on humans or other life forms.
 Commercial chemical product consists of a sole active
ingredient.
 Designated by a U code.
Lindane
 Some products
also contain
acetone, HCL,
sodium hydroxide,
and alcohol.
 Lindane also a
possible toxic
characteristic.
Selenium Sulfide
 2.5% selenium
sulfide in water
and nitric acid.
 Selenium also a
possible toxic
characteristic.
Chemotherapy Drugs
 Taxol.
 Generic names:
Pacitaxel.
 Flash point 60 F.
Chemotherapy Drugs
 Mitomycin.
 Generic names:
Mutamycin,
Mutamycin VHA Plus.
When Pharmaceuticals Become Waste
 A pharmaceutical is considered waste at the time and place the decision is
made to discard it.
 A waste determination must be conducted on a discarded pharmaceutical
to determine if it is hazardous waste.
Spilled, damaged or broken product no longer useable for the intended
purpose.
An item used in cleaning spills (dry absorbent, paper towels, etc.) must
be determined and managed as either hazardous or non-hazardous
waste.
Exception
 Returned for documented credit through the pharmaceutical reverse
distribution system to a manufacturer, wholesaler or reverse
distributor due to an;
 oversupply,
 expiration of the recommended shelf life,
 manufacturer recall,
 product received as a result of a shipping error, or
 product is damaged.
Donated to a charitable organization as described in the Internal
Revenue Code and pursuant to the documentation requirements
of Rule 64F-12, FAC and 499 FS.
 No role in the decision to discard.
General Pharmaceutical Management
Reverse Distribution
 Establish an outdate management program for internal or external
processing. Reverse distributor (compliant w/ RCRA, DEA, and DOH).
Inventory and review all items for eligibility.
Use the manufacturers return policy, to distinguish between
returnable products and non-returnable waste.
Ship pharmaceuticals to a qualified reverse distributor (compliant w/
RCRA, DEA, and DOH).
Establish waste management program. Manage all pharmaceuticals
determined waste as either hazardous or non-hazardous; should
include container, training, emergency procedures, and waste
disposal records (based on generator status).
Don’t
Discard pharmaceutical waste into the trash.
Mix pharmaceutical waste with biomedical waste.
Discard pharmaceutical waste into the septic tank.
Definitions
 Pharmaceutical Reverse Distribution System: The well established practice of
shipping expired or other unusable drug products from pharmacies and drug
wholesalers to pharmaceutical reverse distributors and then to manufacturers with
the intent of receiving credit. Pharmacies and wholesalers may also ship these items
directly to manufacturers depending on manufacturer return policies.
 Pharmaceutical Reverse Distributor: A full-scale pharmaceutical reverse
distributor is primarily engaged in the reverse distribution of pharmaceuticals,
operates a warehouse licensed by the respective state board of pharmacy as a
distributor, and is registered with the Drug Enforcement Administration to handle
controlled substances in Schedules II through V (has notified State/EPA of their
hazardous waste generator activities (SQG/LQG). These are criteria for voting
membership in the Returns Industry Association.
 Third Party Processor or Service Company: Based on distinctions developed by
the Returns Industry Association, a third party processor or service company does
not operate a licensed warehouse, is not regulated by state or federal laws or
regulations, and provides return goods services at the pharmacy under the
supervision of pharmacy personnel. Third party processors may not take possession
of legend drugs or controlled substances.
Function of a Reverse Distributor
 The following apply to potential functions provided by a
reverse distributor.
Reverse Distributor Scenario I
 Hospital or pharmacy or other licensed entity boxes and
ships all expired pharmaceuticals as products to the
reverse distributor which then makes the waste
determination at the reverse distribution facility.
Reverse Distributor Scenario II
 Reverse distributor provides personnel on-site to box and ship
all expired pharmaceuticals (which have already been
segregated by hospital or pharmacy staff) as products to the
reverse distribution facility. An inventory is required for all
controlled substances including a DEA Form 222 for items in
DEA Schedule II. The inventory may be made by either
pharmacy personnel or reverse distributor personnel. Variations
include:
Reverse distributor personnel check active inventory to find all expired
and short-dated (e.g. one month left) pharmaceuticals and then box and
ship to reverse distribution facility.
Reverse distributor personnel inventory all expired pharmaceuticals prior
to shipment but do not make any policy determinations as to eligibility for
return for credit.
Reverse Distributor Scenario III
 The reverse distributor actually compares the expired
pharmaceuticals to a policy database on-site and boxes and
ships only returnable items to the manufacturer. Usually this
scenario would be done by third party processors that do
not operate a warehouse and therefore can only perform
this function. The nonreturnable items are now waste and
the pharmacy is responsible for managing it in compliance
with RCRA and state regulations by identifying, segregating,
and properly storing, labeling, manifesting, transporting and
disposing of RCRA hazardous waste according to federal
and state hazardous waste regulations.
Reverse Distributor Scenario IV
 In addition to doing the policy determination as in Scenario
III, the reverse distributor also does the waste categorization
on-site and manages the disposal of the non-hazardous
component of the waste. This is a very unusual scenario
and has only occurred infrequently.
Reverse Distributor Scenario V
 If the reverse distributor makes a policy decision as in
Scenario III and then ships the nonreturnable items to their
own facility for further segregation into hazardous and
nonhazardous waste, they are shipping hazardous waste in
violation of RCRA and causing both the pharmacy or other
licensed entity and their own facility to be liable for illegal
procedures.
References
Books
Physicians Desktop Reference
Red Book - Pharmacy Fundamental Reference
Drug Facts and Comparisons
US Pharmacopeia National Formulary
Internet Sites
[email protected]
www.pharmacy.ab.umd.edu/~umdi/umdi.htm
www.GISNET/~ROCERYOUNG
http://danpatch.ecn.purdue.edu/~epados/mercury/src/nurse.htm
www.doh.state.fl.us/pharm/
http://www.dep.state.fl.us/waste/categories/hazardous/default.htm
www.epa.gov