Appendix 4: Disposal of Unused/ Expired Pharmaceutical Products

Shelf life of a drug is defined as the time interval within which it remains physically, chemically and/or biologically stable as well as safe and effective for human consumption if stored under the label specified conditions and it is in the original container closure system. Shelf life can be determined by the accelerated stability testing method. Expiry/expiration date is the actual date placed on the label/container indicating the time during which a batch of drug product is expected to remain with the approved shelf life specifications if stored under defined conditions and after which it should not be used. Expired medicines lose their potency and are capable of producing toxins, causing serious reaction or failure of therapy.
Thus disposal of unused/expired pharmaceutical products is required for every pharmacy - retail and wholesale, clinic, dispensary, hospital, manufacturing unit and testing laboratory. Indiscriminate disposal of drugs is likely to pollute the environment resulting in contamination of vegetables, fruits, fish and other aquatic life and even drinking water. Pharmaceuticals and Personal Care Products (PPCP) have been found present as pollutant in water and environment and this poses a serious issue of ecological imbalance due to indiscriminate disposal of expired pharmaceutical products.
With increasing awareness of pollution and their effect on human beings, animals and environment, it is imperative to assure Regulatory compliance by Individuals, Retail and Wholesale Chemists, Clinics, Hospitals, Manufacturers of PPCP, Clinical Research Organizations conducting Biostudies, Analytical Testing Laboratories and other organizations involved in drug distribution (in the event of any disaster) to augment Government efforts.

Managing Disposal of PPCP:

Mass awareness, at every level, of impact of casual approach in such disposal of unwanted and expired PPCP is very much desirable. Following steps are suggested for safe disposal of unused/not required/expired PPCP:
1. Expired or near expiry or unused/not required PPCP in large quantity should be returned by Retail Chemists and Druggists/Pharmacies/Clinics/Hospitals/NGO involved in drug distribution to Wholesalers or stockists of manufacturer(s) who in turn will return the same to the location of the manufacturer where the products were manufactured, for proper disposal.
2. Expired/short expiry PPCP are received at the segregated area for Expired Goods/Market Returns in the Finished Goods Warehouse of the manufacturing location with proper documentation in compliance with Regulatory requirements under i) Drugs and Cosmetics Rules 1945 and amendments therein, ii) Central Excise/State Excise Laws- as applicable and iii) Local authority of Pollution Control Board of the State before under taking disposal of PPCP. Short expiry PPCP should be analyzed and if found satisfactory, could be used for treatment ensuring that it is consumed before expiration.
3. In the event of expired goods returned from overseas customers, appropriate documentation for disposal of PPCP should be provided to the custom authority at the importing port for Bill of Entry.
4. Finished Goods Warehouse receiving the PPCP shall inform Quality System/Quality Assurance authority of the organization for verification and appropriate documenta- tion before undertaking disposal.
5. For small quantity of expired products in Clinics, Hospitals, Health Care Centers and Dispensaries, Pharmacist at the location should be assigned responsibility for disposal of PPCP. He/she should be trained for proper documentation and disposals as indicated below.
6. Disposal of expired retention samples of API, Excipients and that of Pharmaceutical dosage forms in the manufacturing unit or Testing laboratories should be assigned to a responsible Quality control person under supervision of Quality System/Quality Assurance ensuring appropriate documentation.
7. After compliance to administrative control procedure, the expired PPCP should be transferred to a segregated area under the control of Safety, Health and Environment department in the manufacturing location for undertaking disposal.

Disposal Methods of Pharmaceutical and

Personal Care Products

Sorting of Materials:

Materials to be disposed off should be segregated. Different methods are employed depending on

i) Type of dosage forms- Tablets, Capsules, Powders, Injectables, Creams, Ointments, Liquids, Ampoules, Vials, Intravenous Infusions etc.

ii) Chemical nature of drugs e.g. Antineoplastics/Anticancer, β-Lactams, Hormones, Steroids, Anti-infective, Narcotics, Antiseptics and Psychotropic substances etc. Tertiary (Printed/Labelled Corrugated Boxes) and Secondary (Printed Cartons/Paper box) packaging materials are removed and destroyed with the help of heavy duty paper shredder. The methods of disposal of various pharmaceu- tical dosage forms and that of specific category medicines are mentioned below.

Pharmaceutical Dosage Forms

1. Tablets/Capsules:

Up to 50 tablets or capsules soak in about 100 ml of water and collect the same in a polyethylene bag containing used Tea/Coffee grind. Seal the bag and put in trash. Big quantity - Pulverize using heavy duty crusher. Collect in a poly bag and seal. Dispose it in high temperature incinerator (Temp. 850⁰C to 1200⁰C)/approved site for solid waste disposal by the Pollution Control Board of the State.

2. Injectables - ampoules/vials:

Up to 50 Ampoules/Vials (up to 10 ml)-break ampoules/ open vials and collect liquid in a polyethylene bag containing used Tea/Coffee grind. Seal the bag and put in trash. For bigger quantity, use heavy duty crusher to separate liquid and dilute it with water and transfer it to Effluent Treatment Plant (ETP) of the manufacturing unit. Broken glass/vials (after removal of label), rubber stoppers and seals should be disposed off as scrap. Powder Injectables (in Vials/Ampoules) to be disposed off in an incinerator as indicated above.

3. Oral liquids and Intravenous fluids:

Small quantity – Dilute the liquid with water and drain it. For bigger quantity, dilute collected liquid with water and transfer it to ETP of the manufacturing unit.Liquids with high solid contents to be disposed off in an incinerator as indicated above.

4. Semi solids:

Small quantity, mix it with used Tea/Coffee grind in a polyethylene bag. Seal the bag and put in a trash. Deshape the containers/remove the label and discard the containers. Semisolids in bigger quantity to be disposed off in an incinerator mentioned earlier.

Containers - Tubes to be deshaped and remove the label from glass/plastic container before disposal as a scrap.

Specific categories:

1. Anti-infectives-β-lactams:

Small quantity of all β-lactam antibiotics to be destroyed by soaking in 1N Sodium Hydroxide for 30 mins or 1% Hydroxylamine in Water for 10 mins and trash. Bigger quantity to be disposed off in an incinerator (Temp. 850⁰C to 1200⁰C) indicated above.

2. Anti-infectives - others:

Tetracyclines- Small quantity to be soaked in 10% of Calcium Hydroxide/any other Calcium salt in Water for 30 mins and trash. Macrolides- (Erythromycin, Clarithromycin etc.)-Small quantity, soak in 1N Hydrochloric Acid and trash. Amino glycosides ( Gentamycin, Amikacin etc.) - Small quantity dilute with large volume of water and drain it. Bigger quantity of all the above anti-infective should be disposed of in an incinerator as mentioned above.

3. Steroids:

Small quantity- Soak in 1N Sodium Hydroxide for 30 mins and trash. Bigger quantity- all dosage forms (taken out from the primary packing materials) to be incinerated at the temperature range indicated above.

4. Hormones:

Small quantity- Aqueous solution to be exposed to UV for 20 minutes and trash. Estrogens- small quantity in aqueous solution should be exposed to ultrasound at 0.6 and 2 kw in a sonicator for 60 mins. and trash. Bigger quantity- all solid dosage forms (taken out from primary packaging materials) to be incinerated as indicated above.

5. Disinfectants:

Small quantity- use it. Bigger quantity- Not more than 50L. Dilute with enough quantity of water to ensure dilution with loss of activity and drain it in ETP.

6. Controlled substances:

Small quantity- Flush down the toilet to avoid misuse. Bigger quantity- All dosage forms (take out from primary packaging material) to be incinerated as mentioned above.
Disposal by incineration is preferred over chemical inactivation for all dosage forms/APIs.

Cost of Disposal of Pharmaceutical Products:

In India Solid Waste Disposal of PPCP at an approved solid waste disposal site by the local Pollution Control Board works out to Rs. 15 to 25 per kg. Disposal of PPCP by incineration requires about 5% of the fuel feed to that of the total quantity to be disposed of. Total cost of such disposal works out to about 0.5 % to 2% of the total sales.
There is an urgent need to minimise this wastage on account of disposal of Unused/Expired Pharmaceutical products. This not only involves huge cost but also danger of contaminating water bodies, rivers, sea, air, land and aquatic lives, which ultimately get recycled and comes back to human beings, animals and vegetation in one or the other form.

Reuse of Expired Pharmaceutical Products:

In the event of Emergency situation, Regulatory Agencies do allow Revalidation, after Analysis of Expired Pharmaceutical Drug Products, if found satisfactory, for Human/Animal consumption.

Reduction in Level of Disposal:

Reduced level of disposal of PPCP can help significantly. If recovery of API (Active Pharmaceutical Ingredient) and purification there of, out of near expiry/expired PPCP be attempted and regulated, it will reduce the level of PPCP disposal. This will be a challenging task for pharmaceutical professionals, which will help industry in reducing quantum of disposal.

Education and Training:

Continuing education and training at every level is desirable to generate awareness of hazards associated with indiscriminate disposal of unused/expired pharmaceutical products - an emerging environmental issue.
It is expected that awareness of the stakeholders with systematic preventive and corrective actions in time will ensure the safe disposal of unused/expired pharmaceutical products.