William Kappler Environmental Specialist Hazardous Waste Section (407) 893-3323

1. William Kappler Environmental Specialist Hazardous Waste Section (407) 893-3323 bill.kappler@dep.state.fl.us

2. Topics • 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).

3. Pharmaceuticals

4. 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.

5. Ammonia & Alcohol • Pharmaceutical preparations include rubbing alcohol, anesthetic, flexible collodion, coal tar solution, tinctures, and spirits. • Aerosols containing flammable propellants.

6. Ethyl Chloride • Topical anesthetic

7. 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.

8. Acids & Caustics • Glacial Acetic, Tannic, Phosphoric, Sulfuric, Nitric, & Hydrochloric acids. • Sodium Hydroxide.

9. Hydrogen Peroxide • 3% solution has pH of 3 to 4. • 50% solution has pH of 1.

10. 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.

11. 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.

12. 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).

13. Silver Nitrate Sticks • Contains silver also possible oxidizer.

14. Human and Animal Vaccine • Mercury as a preservative.

15. 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.

16. Epinephrine/Adrenaline • An acute hazardous waste if the sole active ingredient. • >1 kg (2.2 LB).

17. NitroQuick • Dosage forms include sterile solutions, tablet, oral spray, patch, and ointment.

18. Nitroglycerin • Patch. • Nitro-Dur, and Nitrodisc.

19. Nicotine • Sold in patch, spray or chewing gum form.

20. Warfarin or Coumadin • When concentration is greater than 0.3%. Acute waste. • When concentration is 0.3 % or less. Toxic waste.

21. 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.

22. Lindane • Some products also contain acetone, HCL, sodium hydroxide, and alcohol. • Lindane also a possible toxic characteristic.

23. Selenium Sulfide • 2.5% selenium sulfide in water and nitric acid. • Selenium also a possible toxic characteristic.

24. Chemotherapy Drugs • Taxol. • Generic names: Pacitaxel. • Flash point 60 F.

25. Chemotherapy Drugs • Mitomycin. • Generic names: Mutamycin, Mutamycin VHA Plus.

26. 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.

27. Exception • Returned for documentedcredit 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.

28. General Pharmaceutical ManagementReverse 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).

29. Don’t • Discard pharmaceutical waste into the trash. • Mix pharmaceutical waste with biomedical waste. • Discard pharmaceutical waste into the septic tank.

30. 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.

31. Function of a Reverse Distributor • The following apply to potential functions provided by a reverse distributor.

32. 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.

33. 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.

34. 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.

35. 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.

36. 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.

37. References • Books • Physicians Desktop Reference • Red Book - Pharmacy Fundamental Reference • Drug Facts and Comparisons • US Pharmacopeia National Formulary • Internet Sites • www.RX@RXLIST.COM • 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