Pharmaceutical waste disposal Guideline
Guideline for Disposal of Pharmaceutical waste (1st
Edition, 2014)
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Pharmaceutical waste disposal Guideline
Contents
1. Definition ................................................................................................................................................. 3
2. Principle and General Requirements .................................................................................................. 3
3. Process flow chart ................................................................................................................................. 4
4. Procedure................................................................................................................................................ 5
5. Recording and reporting of Medical waste ........................................................................................ 7
Table 1: Hazardous Waste List ................................................................................................................ 9
Table 3. Waste Generation Record ....................................................................................................... 10
Table 4: Hazardous Waste Tracking Sheet ......................................................................................... 11
References: ............................................................................................................................................... 12
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Pharmaceutical waste disposal Guideline
1. Definition
In accordance to the Section 47.5 of Waste Prevention and Management Regulation
2012, Pharmaceutical waste includes medicines, biological products (blood, serum,
vaccine) which are expired, incompletely used, damaged, spilled, rejected medicinal
products, and recalled medicinal products.
2. Principle and General Requirements
i. Regardless of the quantity, proper treatment and disposal is necessary owing to wide
range of chemicals present which have inherent health risk and environmental hazards.
ii. Persons handling the hazardous Pharmaceutical waste right from segregation to
disposal should be equipped with protective gears such as hand gloves, mask.
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Pharmaceutical waste disposal Guideline
3. Process flow chart
A. Packaging materials
1. Segregation at
Source B. Hazardous Waste
C. Non-Hazardous Waste
i “Non- Hazardous Pharmaceuticals waste: Liquid waste”
ii. “Non- Hazardous Pharmaceuticals waste: Solid waste”
iii. The used ampoules and vials (But not cytotoxic drugs) to be collected into
“Sharps” containers/bins.
2. Transportation A. Storage before disposal
to Collection Store
Transportation to disposal site
3. Transportation All waste-bag seals should be in place and intact at the end of transportation.
to Disposal Site
4. Disposal A. Hazardous Waste: Encapsulation and Landfill
Methods
B. Non-Hazardous Solid waste: Landfill
C. Non-Hazardous Liquid Solid waste: Sewer
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Pharmaceutical waste disposal Guideline
4. Procedure
1. Segregation at Source
A. Packaging materials
The secondary packaging should be removed and disposed as general dry waste as
per the method under the Medical Waste guideline. The contaminated packaging
materials with medicinal products should be treated as Pharmaceutical waste.
B. Hazardous Waste
i. Segregate the pharmaceuticals waste into Hazardous according to the Hazardous list
as per the Table i.(Hazardous List).
ii. Discard Hazardous waste into the leak –proof (double layered) purple plastic bags
or containers and labelled as “Hazardous Pharmaceuticals waste” with the name of
place where produced (e.g. ward).
iii. Biological and vaccines should be treated as infectious waste and disposed
accordingly.
C. Non-Hazardous Waste
i. Pharmaceuticals not listed on the hazardous list should be considered as non-
hazardous and should be further segregated into liquid and solid /semi solid
dosage forms.
ii. The non-hazardous Pharmaceuticals waste should be discarded into the green plastic
bags or containers and labelled as “Non- Hazardous Pharmaceuticals waste:
Liquid waste OR Non- Hazardous Pharmaceuticals waste: Solid waste” and
name of place where produced.
iii. The used Ampoules or vials ampoules which contained Non-hazardous
Pharmaceutical wastes should be crushed on a hard, impermeable surface and
disposed off as “Sharps”.
2. Transportation to Collection Store
A. Storage before disposal
i. In the health facilities, pharmaceuticals waste in hospital wards or departments should
be returned to the pharmacy store for disposal with a duly filled waste generation
record
ii. For the private pharmacies, the pharmaceutical waste should be stored separately
prior to disposal.
3. Transportation to Disposal Site
All waste-bag seals should be in place and intact at the end of transportation.
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Pharmaceutical waste disposal Guideline
4. Disposal Methods
A. Hazardous Waste: Encapsulation and Landfill
i. It should be immobilized or encapsulated prior to disposal into landfill as per the
encapsulation method below:
a. If the waste is with their secondary packages, remove materials from their
package but not from the primary packaging (strips/blisters/bottles/sachets).
b. Fill a steel/plastic drum up to 75% capacity with pharmaceutical waste
c. Fill the remaining space with the following at approximate ratios by weight:
Cement 15%
Lime 15%
Water 5% or more to obtain required consistency
d. Close the lids of the drum and place the drums at the base of the land fill and
cover with soil.
e. Once the wastes are encapsulated, it may be disposed off with the municipal
wastes or ordinary landfill.
ii. Incineration of hazardous pharmaceutical waste is an option.
Incinerators
a. The incinerators should be set according to the environment control strategies
of the National Environment Commission (NEC).
b. The incinerators should have the following specifications:
Type: rotary kiln incinerators
Chambers: Two
Minimum Temperature 1100 degree Celsius
Capacity Range Depending on the waste generated data.
c. Pressurized containers should not be incinerated as it may explode during
incineration and cause damage to the equipment.
d. Wastes with high heavy-metal content (e.g. lead, cadmium, mercury) should not
be incinerated as it will cause emission of toxic metals into the atmosphere.
e. Hazardous pharmaceutical wastes, including wastes containing more than 1%
halogenated compounds, should be incinerated in rotary kiln incinerators with a
minimum temperature of 1100 °C.
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Pharmaceutical waste disposal Guideline
f. The wastes should be mixed with cardboard, and possibly with other combustible
material for incineration.
g. The residues of incineration should be land filled.
B. Non-Hazardous Solid waste: Landfill
Non-hazardous pharmaceutical wastes should be disposed off in a solid land fill, as
identified by the local Health Administration Head or Local municipality.
C. Non-Hazardous Liquid Solid waste: Sewer
i. Non-hazardous pharmaceutical liquid dosage form waste such as large volume
parenteral fluids (salts, amino acids, lipids, glucose), vitamins and eye drops (but not
antibiotics or cytotoxic drugs can be diluted (dilution factor - water in 1:3 Ratio) and
flushed into the sewers in small quantities.
ii. Fast flowing water sources should be used to flush the diluted liquid pharmaceutical
wastes.
iii. Do not discharge even small quantities of pharmaceutical waste into slow-moving or
stagnant water bodies.
iv. Non hazardous liquid waste other than large volume parenteral fluids (salts, amino
acids, lipids, and glucose), vitamins and eye drops should be land filled as it is.
5. Recording and reporting of Medical waste
Recording and reporting of medical wastes is important for the future planning on
infrastructure, logistics and manpower. It will also serve the purpose of monitoring the
compliance to the Medical waste management guideline.
Waste generated from all units and taken to the storage facility should be individually
weighed and reported as per the recording and reporting form
1. Weighing of waste:
i. Equipments:
Appropriate personnel protective equipments
Appropriate weighing machine
ii. Methods to weigh waste:
The total waste generated from the facility should be weighed at the
common storage site and recorded on the register/Form.
The wastes should be weighed without opening the plastic bags
2. Responsible persons
i. The designated personal for the intended purpose should be responsible for
weighing and recording.
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Pharmaceutical waste disposal Guideline
ii. The Focal Person for infection control and medical waste management or the
competent person (pharmaceutical waste) should compile the total waste
generated and report to the relevant committee or agency.
3. Frequency of reporting
i. Every Private Pharmaceutical dealers should submit their annual compliance and
monitoring status report to the DRA yearly.
ii. The annual compliance and monitoring status report should contain amount
of waste generated in that particular year, disposal methods adopted and
challenges in implementing the guideline or comments made by the monitoring
committee(if any).
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Pharmaceutical waste disposal Guideline
Table 1: Hazardous Waste List
i. All chemotherapy drugs
ii. Immunosuppressant drugs
iii. Other Category of drugs:
Epinephrine
Phentermine
Physiostigmine
Nitroglycerine
Warfarin
Coumarol
Adrenalin
Disulfiram
iv. Chemicals:
Phenol
Lindane
Choral Hydrate
Chloroform
Ethyl Ether
Fluori- methane
Formaldehyde
Naphthalene
Selenium
Pharmaceuticals containing heavy metals(Barium, mercury, cadmium,
Thiomersal)
Note: This list is not comprehensive; it is subject to revision as and when notified by
National Environment Commission.
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Pharmaceutical waste disposal Guideline
Table 3. Waste Generation Record
Name of the Premise/source of generation:
Reported by:
Verified by:
Date of reporting:
Sl no Type of Waste Hazardous/ Non-Hazardous Qty (kg)
(Put H for Hazardous, NH for
(Circle the appropriate
Non- Hazardous)
category of waste)
a. General Waste
b. Infectious Waste
c. Pathological Waste
d. Sharps
e. Chemical waste List the chemical names: H:
H:
NH: NH:
f. Pharmaceutical waste List the Pharmaceuticals:
H:
NH:
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Pharmaceutical waste disposal Guideline
Table 4: Hazardous Waste Tracking Sheet
Reported by (Name & Signature):
Verified by (Name & Signature):
Date of reporting:
Waste consignment no.
(Ref no./Dispatch no. from the register)
Category of Waste:
Name of health facility/Unit/Pharmacy
premises
Approximate Quantity:
Date of Dispatch:
(Date when the waste is being
transported to the disposal waste)
Signature of the Focal person/in-
charge/Competent Person)
Name and Signature of the person
receiving the waste for disposal (where
disposal is done by a different party
other than the In-charge/competent
Person)
DISPOSAL METHOD
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Pharmaceutical waste disposal Guideline
References:
1. WHO Guidelines for safe disposal of unwanted Pharmaceuticals in and after
emergencies.
2. USA, Hazardous Waste Characterization, Framework for Resource Conservation
and Recovery Act.
3. USA, Florida Department of Environment Protection: List of Pharmaceuticals that
are potentially hazardous waste when discarded.
4. Vestara, Managing Pharmaceutical Waste; A discussion Guide for Health –System
Pharmacists
5. Tanzania Food and Drug Administration
6. Waste Prevention and Management Regulation 2012
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