Cytotoxic/Cytostatic waste
Cytotoxic drugs describe a group of medicines containing chemicals toxic to cells, preventing cell growth or replication, and are used to treat cancer and other disorders. Once inside the body they can produce side effects both to the intended patient and others who become exposed.
Cytotoxic/cytostatic medicines are hazardous substances, as defined by the Control of Substances Hazardous to Health Regulations 2002 (COSHH). All waste cytotoxic and cytostatic medicines must be disposed of through a separate waste stream.
Please note:
- This ONLY applies to cytotoxic and cytostatic medicines which have been specifically manufactured for administration to humans or animals.
- It DOES NOT apply to items manufactured for research and development, these are still hazardous but should be disposed of through the hazardous waste stream.
The Faculty has introduced the PURPLE waste stream specifically for cytotoxic/cytostatic waste medicines. In the majority of cases, this will only apply to the original stock bottles/containers that the medicine was supplied in along with any syringes or pipette tips that have been used to reconstitute the medicine. Where serial dilutions or aliquots have been made please refer to the threshold/concentration limits which determine if the items are still categorised as cytotoxic waste.
A list of cytotoxic/cytostatic medicines, the Hazardous Properties associated with these medicines and any threshold or concentration limits which may apply can all be found in the sections below.
If you require any advice please contact the Compliance and Risk team (FBMHhealthandsafety@manchester.ac.uk).
Purple waste stream
Cytostatic and cytotoxic waste medicines must be disposed of using the "Purple" waste stream. These are incineration (sharps) bins with a purple lid. Only cytotoxic/cytostatic medicines or sharps/tubes/tips contaminated with cytotoxic/cytostatic medicines are to be disposed of in these bins.
Purple waste bins
Purple waste bins will be available to purchase through Stopford Stores.
Initially one size of bin will be held in stock. If you require larger bins they can be purchased through eMarketplace, please check with stores or the Compliance and Risk team before purchasing as they will need to fit in to the collection container for removal by the waste contractor.
Protocol for disposal in Biomedical Corridor
- Purple bins should be dated when used for the first time.
- They must be discarded after 3 months usage regardless of whether they are full or not.
- Sealed bins should be transported through the bridge links to the Stopford Stores desk and hand it over to a member of stores staff who will place it in the designated purple waste container.
NHS sites/Alderley Park/Oglesby Cancer Research
The purple waste stream is already in place on all NHS sites, Alderley Park and at the Oglesby Cancer Research Centre. If you have waste cytotoxic/cytostatic medicines which you need to dispose of at these sites please contact your Technical Operation Manager for further information.
List of Cytotoxic/Cytostatic drugs
This list is intended as a guide and is not an exhaustive list. Please check the material safety data sheets for further guidance, if you are unsure as to the Cytotoxic and Cytostatic properties of a medicine please contact the FBMH Compliance and Risk Team.
| Aldesleukin | Doxorubicin | Mitoxantrone |
| Alemtuzumab | Dutasteride (women should not handle) | Mycophenolate mofetil |
| Amsacrine | Epirubicin | Nafarelin |
| Anastrozole | Estradiol | Oestrogen containing products |
| Arsenic trioxide | Estramustine | Oxaliplatin |
| Asparaginase | Etoposide | Oxytocin (incl. syntocinon & syntometrine) |
| Azathioprine | Exemestane | Paclitaxel |
| Bacillus Calmette-Geurin Vaccine (BCG) | Finasteride (women should not handle) | Pentamidine |
| Bicalutamide | Fludarabine | Pentostatin |
| Bleomycin | Fluorouracil | Podophyllyn |
| Bortezomib | Flutamide | Procarbazine |
| Busulphan | Ganciclovir | Progesterone containing products |
| Capecitabine | Gemcitabine | Raloxifene |
| Carboplatin | Gemtuzumab | Raltitrexed |
| Carmustine | Gonadotrophin, chorionic | Ribavarin |
| Cetuximab | Goserelin | Rituximab |
| Chlorambucil | Hydroxycarbamide | Sirolimus |
| Chloramphenicol | Idarubicin | Streptozocin |
| Ciclosporin | Ifosfamide | Tacrolimus |
| Cidofovir | Imatinib mesylate | Tamoxifen |
| Cisplatin | Interferon products (incl. peginterferon) | Temozolomide |
| Cladribine | Irinotecan | Testosterone |
| Coal tar containing products | Leflunomide | Thalidomide |
| Colchicine | Letrozole | Thiotepa |
| Cyclophosphamide | Leuprorelin acetate | Topotecan |
| Cytarabine | Lomustine | Toremifene |
| Dacarbazine | Medroxyprogesterone | Trastuzumab |
| Dactinomycin | Megestrol | Trifluridine |
| Danazol | Melphalan | Triptorelin |
| Dasatinib | Menotropins | Valganciclovir |
| Daunorubicin | Mercaptopurine | Vidaradine |
| Diethylstilbestrol | Methotrexate | Vinblastine |
| Dinoprostone | Mifepristone | Vincristine |
| Dithranol containing products | Mitomycin | Zidovudine |
| Docetaxel | Mitotane |
Hazardous Properties - HP
Under the Hazardous Waste Regulations (2005) a cytotoxic/cytostatic medicine is defined as any medicine that displays one or more of the following hazardous properties: Acute Toxicity (HP6), Carcinogenic (HP7), Toxic for Reproduction (HP10) or Mutagenic (HP11).
- HP6: Toxic substances and preparations which if they are inhaled or ingested or if they penetrate the skin, may involve serious, acute or chronic health risks.
- HP7: Carcinogenic substances and preparations which if they are inhaled or ingested or if they penetrate the skin may induce cancer or increase its incidence.
- HP10: Toxic for Reproduction (teratogenic) substances and preparations which if they are inhaled or ingested or if they penetrate the skin may produce or increase the incidence of non heritable adverse effects in the progeny and or the male or female reproductive functions or capacity.
- HP11: Mutagenic substances and preparations which if they are inhaled or ingested or if they penetrate the skin may induce hereditary genetic defects or increase their incidence.
Concentration and Threshold Limits
HP 6: Acute Toxicity
Annex III of the Waste Framework Directive defines HP 6 ‘Acute Toxicity’ as: ‘waste which can cause acute toxic effects following oral or dermal administration, or inhalation exposure’.
Cut-off values
The following cut-off values apply to the assessment:
• For H300, H310, H330, H301, H311, and H331 : 0.1%
• For H302, H312, H332: 1%
An individual substance present at a concentration equal to or above the cut off value listed above must be disposed of in the Purple waste stream.
| Hazard Class & Category Code | Hazards Statement | Description | Concentration Limit (sum of substances) |
| Acute Tox.1 (Oral) | H300 | Fatal if swallowed | ≥ 0.1% |
| Acute Tox. 2 (Oral) | H300 | Fatal if swallowed | ≥ 0.25% |
| Acute Tox. 3 (Oral) | H301 | Toxic if swallowed | ≥ 5% |
| Acute Tox.4 (Oral) | H302 | Harmful if swallowed | ≥ 25% |
| Acute Tox.1 (Dermal) | H310 | Fatal in contact with skin | ≥ 0.25% |
| Acute Tox.2 (Dermal) | H310 | Fatal in contact with skin | ≥ 2.5% |
| Acute Tox.3 (Dermal) | H311 | Toxic in contact with skin | ≥ 15% |
| Acute Tox. 4 (Dermal) | H312 | Harmful in contact with skin | ≥ 55% |
| Acute Tox.1 (Inhal.) | H330 | Fatal if inhaled | ≥ 0.1% |
| Acute Tox.2 (Inhal.) | H330 | Fatal if inhaled | ≥ 0.5% |
| Acute Tox. 3 (Inhal.) | H331 | Toxic if inhaled | ≥ 3.5% |
| Acute Tox. 4 (Inhal.) | H332 | Harmful if inhaled | ≥ 22.5% |
HP 7: Carcinogenic
Annex III of the Waste Framework Directive defines HP 7 ‘Carcinogenic’ as: ‘waste which induces cancer or increases its incidence’.
An individual substance present at a concentration equal to or above the concentration limit listed in the table below must be disposed of in the Purple waste stream.
| Hazard Class & Category Code | Hazards Statement | Description | Concentration Limit (Individual substance) |
| Carc. 1A | H350 | May cause cancer | ≥ 0.1% |
| Carc. 1B | |||
| Carc. 2 | H351 | Suspected of causing cancer | ≥ 1.0% |
HP 10: Toxic for Reproduction
Annex III of the Waste Framework Directive defines HP 10 ‘Toxic for Reproduction’ as: ‘waste which has adverse effects on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring’.
An individual substance present at a concentration equal to or above the concentration limit listed in the table below must be disposed of in the Purple waste stream.
| Hazard Class & Category Code | Hazards Statement | Description | Concentration Limit (Individual substance) |
| Repr. 1A | H360 | May damage fertility or the unborn child | ≥ 0.3% |
| Repr. 1B | |||
| Repr. 2 | H361 | Suspected of damaging fertility or the unborn child | ≥ 3.0% |
HP 11: Mutagenic
Annex III of the Waste Framework Directive defines HP 11 ‘Mutagenic’ as: ‘waste which may cause a mutation, that is a permanent change in the amount or structure of the genetic material in a cell ’.
An individual substance present at a concentration equal to or above the concentration limit listed in the table below must be disposed of in the Purple waste stream.
| Hazard Class & Category Code | Hazards Statement | Description | Concentration Limit (Individual substance) |
| Muta. 1A | H340 | May cause genetic defects | ≥ 0.3% |
| Muta. 1B | |||
| Muta. 2 | H341 | Suspected of causing genetic defects | ≥ 3.0% |