Handling and Disposal of Unfit Medicines and Cosmetic Products

Procedures for Handling and Disposal of Unfit Medicines and Cosmetic products

Students Learning Tasks

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

Define the terms “ unfit medicines and cosmetic products”

Describe the handling of unfit medicines and cosmetic products at facility level

Describe the procedures for application to dispose off unfit medicines and cosmetic products

prepare the format of the Register Book of unfit medicines/cosmetic products(Annex I)

prepare Model of Application form for disposal of unfit products(Annex II)

Definition of Unfit Medicines and Cosmetic products

Unfit medicines and cosmetic products

Medicines and Cosmetic products shall be considered as unfit when they are:

expired

improperly sealed

damaged, unexpired and improperly stored

improperly labelled

counterfeit, substandard and adulterated

prohibited

unauthorized

Prohibited drugs means any drug declared to be a prohibited drug in terms of the provisions of section 81 of this Act (TFDC Act).

Counterfeit : a drug, medical device or herbal drug shall be deemed to be counterfeit if –

it is manufactured under a name which belongs to another drug; or

it is an imitation of, or is a substitute for, another drug, medical device or herbal drug resembles another drug or medical device likely to deceive or bears upon its label or container the name of another drug, medical device or herbal drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug, medical device or herbal drug; or

the label or container bears the name Of an individual or company purporting to be a manufacturer of the drug, medical device or herbal drug; which individual or company is fictitious or does not exist; or

it has been substituted wholly or in Part by another drug substances; or

it Purports to be it is a Product of manufacturer of whom it is not truly product.

Expired: means a product should not be sold because of an expected decline in quality or effectiveness after a certain date.

Substandard products are products that do not meet their quality standards and specifications.

Handling of Unfit Medicines and Cosmetic products at Facility level

Handling of Unfit Medicines and Cosmetic products at Facility level

In order to manage properly unfit medicines and cosmetic products at a facility level, the following requirements shall be adhered to:

Maintain a register book (Annex I) for unfit medicines and cosmetic products

Keep them into different categories by dosage form such as:-

Solids, semi-solids and powders: capsules, powders for injection, tablets, granules, creams, gels, suppositories etc.

Liquids: Solutions, suspension, syrups, mixtures, lotions, aerosol, inhalers etc.

Keep separately medicines which fall under controlled drugs, antineoplastics, antibiotics and any other hazardous medicines or cosmetic products.

Keep in containers according to their dosage forms to facilitate verification exercise, sorting and selection of disposal method

Demarcate an area for keeping containers of unfit medicines and cosmetic products which shall be labeled conspicuously with words “Expired medicines/ cosmetic products – Not for Sale” or “Unfit medicines/cosmetics – Not for sale” or “Dawa/Vipodozi hivi muda wake wa matumizi umekwisha – visiuzwe” au “Dawa/Vipodozi hivihavifai kwa matumizi – zisiuzwe” in red ink.

Maintain safe custody of unfit pharmaceutical products in registered premises until they are disposed off to avoid pilferage.

The decision of when to initiate disposal of unfit medicines and cosmetic products shall be made by regional, district or hospital pharmacist, owners, in-charge of facility, dispensers, and inspectors (including inspectors at ports of entry) to avoid accumulation of such products.

Application for disposal of unfit medicines from Government institutions shall be accompanied by an approval from Accountant General declaring that the product have been written off and that are subject to disposal as required by law under Section 256 of the Public Finance Regulations,2001.

Procedures for Application to dispose off Unfit Medicines and Cosmetic products

Any person who intends to dispose off unfit medicines or cosmetic products shall adhere to the following procedures:

Request in writing to the Director General of TFDA by using application for (Annex II) which is available at TFDA headquarter offices, TFDA zone offices, Regional and District Medical officer’s offices and TFDA website: www.tfda.ac.tz.

A request shall be accompanied with a list of products to be disposed of and should state clearly trade name, generic name and strength (where applicable), dosage form, pack size, quantity, manufacturer, batch number and market value of product.

Once the request has been received by TFDA, the Authority shall acknowledge and inform the applicant through a letter to contact Directorate of Medicines and Cosmetics to arrange or TFDA zone offices for verification of the product. In case of regions where there are no TFDA zone offices, applicant shall be informed to contact the Regional or District Medical officer’s offices for the same.

TFDA-HQ or TFDA zone office/Regional/District Medical officer’s offices shall send inspectors to the premises to verify and authenticate the information submitted.

Format of the Register Book of Unfit Medicines /Cosmetic products

Important information in the Register book:

Name of the product

trade name

generic name

Strength of the product(where applicable)

Dosage form: suspension, cream, ointment, tablet,….

Pack size

Quantity

Batch number

Value(Tshs.)

Annex I

Format of Register Book

S/N

Name of a product

Name of a product

Strength where applicable

Dosage form

Pack size

quantity

Batch number

Value

(TZs)

Trade name

Generic name

Strength where applicable

Dosage form

Pack size

quantity

Batch number

Value

(TZs)

STEP 6: Model of Application form for Disposal of Unfit products (10 minutes)

Important information in Application Form for Disposal

Form number

Postal address of TFDA

Postal address of the applicant

Specification of type of business of the applicant

Type of products to be disposed

License number

Date of issue

Location of business

Name of in-charge and reg. number

Reason for disposal

Weight of the total products in Kg

Value of the total products in Tshs

Declaration by the applicant

Name of the receiving officer, signature and official stamp.

Format of the application form for disposal

Annex II

Form No……………

To: Director General

Tanzania Food and Drugs Authority

P.O Box 77150

Dar-es-Salaam

I/We……………………………………………………………………………………………………

of (postal address)…………………………………………………..undertaking the business of (specify)………………………………………………………………………………

……………………………………here by apply for disposal of unfit (specify type of products) ……………………………………… ………. License Number………..issued on…………………………………………………………….

Location of Business…………………………………………………………………………….

Name of In charge of the business……………………………………………Registration

Number (if applicable)……………………………………………………….

Reason for disposal………………………………………………………………………………..

Weight (in Kg)………………………………………………………………………………………..

Value (in Tshs)……………………………………………………………………………………..

Attached herewith is the list of products to be disposed off.

Declaration:

I certify that the information provided in the application form is true and correct.

Date of application…………………………… Signature of Applicant……………………..

Stamp…………………………………………

For official use only:

Received by: ……………………………….. Signature………………………………………

Stamp…………………………………………..

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