TMPharmaceutical Primer

MULTI-AGENCY REGULATED PHARMACEUTICALSMany pharmaceuticals are regulated by multiple agencies. When they become waste, it is very common for the waste to be regulated by EPA, DOT, and the states it is shipped to/from. This can be compounded when the waste is a DEA regulated material. Several examples of these types of wastes are listed in the table below.

WHEN IS A PRODUCT A WASTE?EPA and many states consider an outdated pharmaceutical to be a waste when the decision is made to discard it. Additionally, any pharmaceutical that has no known manufacturer/distributor credit value must be treated as waste, and if hazardous, only shipped to an EPA-approved hazardous waste facility, using a DOT approved hazardous waste transporter.

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PHARMACEUTICAL SERVICESTM

Who We AreStrong Pharmaceutical Services, a division of Strong Environmental, Inc., is the leading provider of destruction services to the pharmaceutical industry. Our experienced professionals manage and ensure the appropriate witnessed destruction of DEA controlled substances, as well as proper disposition of RCRA hazardous and non-hazardous finished goods and manufacturing wastes. When we take control of waste materials at your shipping dock, they become our full responsibility.

Strong Pharmaceutical Services: Secure Pharmaceutical Destruction Solutions

Strong Pharmaceutical Servicesa division of Strong Environmental, Inc.

6264 Crooked Creek Road Norcross, GA 30092770.409.1500 800.778.7664

www.StrongPharma.com Solutions@StrongPharma.com

© Copyright 2008, Strong Environmental, Inc.

WHICH DISCARDED PHARMACEUTICALS BECOME EPA HAZARDOUS WASTE?A number of commonly used pharmaceuticals become hazardous waste when discarded. If the sole active ingredient of a pharmaceutical is a P-listed (Acute Hazardous Waste) or U-listed (Toxic Waste) chemical, then it will be considered EPA Hazardous Waste (40 CFR §261.33 (e),(f)). Also, if the product has the characteristics of hazardous waste (ignitability, toxicity, corrosivity, or reactivity) they are EPA Hazardous Waste (40 CFR §261.20-261.24).

DOES MY STATE ALSO REGULATE HAZARDOUS WASTE? Many states administer their own hazardous waste management and regulatory programs under the Resource Conservation and Recovery Act (RCRA), and may have additional waste codes. States may also have specific

regulations affecting pharmaceuticals and disposal without the addition of state waste codes. Examples include: California: 311 Massachusetts: MA99 Maine: MRD009 Michigan: 014L, 029L Minnesota: MN01 Rhode Island: R001 Vermont: VT99 Oregon: ORX007 (& OR codes for EPA codes)Texas: (numerous generator specific codes)

HOW DOES DOT DEFINE “TOXIC?” Poisonous or toxic means a material, other than a gas, which is known to be so toxic to humans as to afford a hazard to health during transportation. This can also be determined from LD50 values. Specific values determine the actual packing group for the material. Please consult 49 CFR §173.132 for detailed information on determining DOT toxicity.

continued

Examples of Multi-Agency Regulated Wastes

Name EPA DEA DOT State (ex.) Chloral hydrate U034 C-IV UN2811 CA 311 Diazepam (inj.) D001 C-IVN UN1993 CT CR04 Paraldehyde U182 C-IV UN1264 RI R003c Phentermine P046 C-IV UN3007 MN 01Safe transport and disposition of these heavily-regulated materials can be complex. Strong provides the knowledge and expertise required to safely manage all hazardous, non-hazardous and controlled substance wastes.

01-01-2008 U034 311

UN2811, Waste Toxic Solids, Organic

n.o.s. (Chloral Hydrate), PGII, ERG-154

Generator Name

123 Address Lane

City State

EPA123456789 000283001

Solids

x x

1993

Acetone U002Azaserine U015Chlorambucil U035Chlornaphazin U026Chloral U034Chloral hydrate U034Chloroform U044Coumadin®/Warfarin<0.3% U248Cyclophosphamide U058Daunomycin U059Dichlorodifluoromethane U075

Diethylstilbestrol U089Ethyl acetate U112 Ethyl carbamate U238Formaldehyde U122Formic acid U123 Hexachlorophene U132Lindane U1293-Methylchloranthrene U157 Mytomycin C U010 Melphalan U150Mercury U151

Paraldehyde U182 Phenacetin U187Phenol U188Reserpine U200Resorcinol U201Saccharin U202Selenium sulfide U205Streptozotocin U206Trichloromonofluoromethane U121Uracil mustard U237

Acetic Acid P058 Adrenalin/Epinephrine P042Arsenic trioxide P012Benzyl chloride P028 Coumadin®/Warfarin>0.3% P001Nicotine P075Nitric oxide P076 Nitroglycerin† P081Phentermine P046 Physostigmine P204Physostigmine salicylate P188Sodium Azide P105Strychnine P108

EPA LISTED WASTES (SOLE ACTIVE INGREDIENT)

EPA CHARACTERISTIC HAZARDOUS WASTES

Note: The above lists of hazardous pharmaceutical wastes are provided as examples, and are incomplete. If you have any questions about the classification of any waste material, call Strong. Most states also regulate pharmaceuticals. Check with your regulatory agencies or Strong.

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EXAMPLES: U-LISTED EXAMPLES: P-LISTED

CHARACTERISTIC OF IGNITABILITYHazardous Waste Code: D001A liquid, other than an aqueous solution containing ≤ 24% alcohol by volume, exhibiting a flash point ≤ 140ºF

Examples• Rubbing alcohol • Some injections • Some topical preparations • Tooth ache (Anbesol®) • Dandruff medications (coal tar solutions) • Benzocaine • Wart Remover (Compound W®) • Acne treatments (Neutrogena Acne®, Pan Oxyl®, Clear by Design®, On-The-Spot®, Vanoxide®) • High alcohol content formulations (Nyquil®, Anbesol®, Cleocin-T®, Beuthanasia-D®, Compound W®, dental antiseptic rinses)

CHARACTERISTIC OF TOXICITYHazardous Waste Codes: D004 through D043Approximately 40 chemicals which meet specific leaching concentrations

Examples • Arsenic (D004) • Barium (D005) • Cadmium (D006) • Chromium (D007)• Lead (D008) • Lindane (D013) • Mercury (D009) • Selenium (D010) • Silver (D011) • Thimerosal (D009)

CHARACTERISTIC OF CORROSIVITYHazardous Waste Code: D002An aqueous solution having a pH of ≤ 2 or ≥ 12.5

Examples• Compounding chemicals • Glacial acetic acid• Sodium hydroxide (lye) • Arzol silver nitrite (also D011)

CHARACTERISTIC OF REACTIVITYHazardous Waste Code: D003Meets any of the eight properties of explosive or reactive wastesExample• Nitroglycerin†

† Nitroglycerin formulations may be considered excluded from the P081 listing as Hazardous Waste Code D003 (typ.) non-reactive as of August 14, 2001 under FR: May 16, 2001, unless they exhibit another characteristic, such as ignitability. Nitroglycerin in finished product dosage form is generally RCRA exempt, but may be State hazardous. (Source: Vol. 66, FR 95, page 27266)