Destruction of Unfit Medicines and Cosmetic Products

Destruction of Unfit medicines and Cosmetic Products

Students Learning Tasks

By the end of this session students are expected to be able to:

Identify different Participants involved in the Destruction process

Describe the procedures for Destruction of Unfit Medicines and Cosmetic products

Describe the Model of Drug Disposal Form of Unfit Medicines and Cosmetic products

Describe the Model of Certificate of Destruction of Unfit Medicines and Cosmetic products

Identification of Different Participants involved in the Destruction Process

Identification of Different Participants involved in the Destruction Process

It is the responsibility of the Tanzania Food and Drug Authority to implement the guidelines in coordination with regional and local health authorities, as well as with the directors of health facilities that face the problems of drug disposal.

A local task force or advisory committee should be established at an early stage to assess, analyze and address the problem of drug disposal, and to monitor activities. Furthermore, it is suggested that such a task force has a maximum of five members and that meetings are held as near to the site of the stockpile as possible.

Members/supervisors are chosen from:

the drug regulatory authority

the ministry of health;

the police authority

institutional pharmacists;

A qualified hazardous waste expert may be appointed by the authority to be responsible for pharmaceutical waste disposal. If this is done the person appointed should become a member of the task force. The individual can be an expert in environmental management, a registered water chemist, hydro-geologist or sanitary engineer. The choice of expert depends on the technical problems to be faced.

Therefore the destruction exercise shall be supervised by Health Officer, Environmental Officer, Policeman and Drug Inspector, and the owner/witness/superintended (pharmacist in charge) of the business.

Procedures for Destruction of Unfit Medicines and Cosmetic Products

Destruction of unfit medicines and cosmetic products shall involve the following procedures:

A Drug Inspector, Health Officer, Environmental Officer and Policeman shall supervise the transport of consignment from the owner’s premises to the disposal site for destruction exercise.

The destruction exercise shall be supervised by Health Officer, Environmental Officer, Policeman and Drug Inspector.

Unfit medicines and cosmetic products shall be transported in a closed motor vehicle to avoid pilferage.

Supervisors shall wear protective gears such as overalls, gloves, masks, caps and boots during the exercise.

Upon completion of the exercise, a Drug Disposal Form (Annex V) shall be duly filled in and signed by the supervisors and owner/owner’s representative.

Drug Disposal Form shall be sent to TFDA headquarter offices.

Once TFDA has received the form, a certificate of destruction of unfit medicines and cosmetic products (Annex VI) shall be prepared and sent to the consignee.

Particular care shall be taken while handling anti cancer drugs, narcotic drugs and penicillins to avoid associated hazards.

Description of Model of Drug Disposal Form of Unfit Medicines and Cosmetic products

Important information in the Disposal Form

Name and address of the owner of the products destroyed

Location/site where destruction exercise was conducted

Date of the destruction exercise

Methods of destruction used

Total weight (Kg) and value(Tshs) of the products destroyed

Name and signature of owner/in charge/representative of the organization

Names, title and signatures of Drug Inspector, other supervisor(s) and witness of the disposal exercise.

The Model of the form:

(Annex V)

Model of Disposal Form

Form No………

(Pursuant to Section 99 of the Tanzania Food, Drugs and Cosmetics Act, 2003)

The Tanzania Food and Drugs Authority declares to have supervised the

disposal of unfit product (as per attached list) belonging to

M/S……………………………………………………………………………………………

of postal address……………………………………………………………………………

The destruction exercise was conducted at (location, site)

……………………………………………on this date ………………………………………

by the following method(s) (state clearly):-

1……………………………………………………

2……………………………………………………

3……………………………………………………

The total weight of the products destroyed is ……………………………………… Kg

and value is ………………………………………. Tshs.

Name and signature of owner/in charge/representative of the organization:

…………………………………… …… …………………………………….

(Name) (Signature)

Names, title and signatures of Drug Inspector(s), other supervisor(s) and

Witness of the disposal exercise:-

Name: Title/Position: Signature & Date:

1………………………… ……. …………………….… ……………………

2…………………………. …………………. …………. ..…..………………

3………………………… …. ……………………. …… ……………………

4…………………………. . ……………………. ……… ……………………

5………………………… …. …………………………… …………………….

Description of model of certificate of Destruction of Unfit Medicines and Cosmetic Products

Important Information in the Certificate of Destruction

Reference number of the certificate

Date

Name and postal address of owner

Methods of destruction

Place/site of destruction

Serial number of the attached disposal form

Weight(Kg) and value(Tshs) of products disposed

Name and signature of Director General

Annex VI

Model of Certificate of Destruction

Ref. No……………………………..… Date: ………………………..

THE TANZANIA FOOD, DRUGS AND COSMETICS ACT, 2003

CERTIFICATE OF DESTRUCTION

I, being the person in-charge with the administration of the law relating to the

Control of Pharmaceutical Products to which the Tanzania Food, Drugs and

Cosmetics Act, 2003 apply, hereby certify the destruction of expired

Pharmaceutical products belonging to………………………………………………….

of (Postal Address) …………………………………………………………… which took

place on……………………………………………………………………………………………….

The said consignment was destroyed by……………………………………………………

at………………………………………………….. …..under the witness and supervision

of Drug Inspector, Environmental Officer, Health Officer and Police as

specified in the attached disposal form with S.No. …………………………………..

The weight of the whole lot disposed is ………………….. Kg and its value is

……………… Tshs.

…………………………….

Name and Signature of Director General

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