Pharmaceuticals and Poisons Act

The purpose of this Act was to provide for the control of the profession of pharmacy and matters relating to dealings in pharmaceuticals and poisons. Pharmaceuticals are defined by the act as "any drug, substance, or other article manufactured or prepared in any way and intended for use by man as a medicine or as a remedy used for the purpose of medical, dental or veterinary treatment."

A poison is defined as "any pharmaceutical product listed in the poisons list referred to in section 33" of the Act. Several regulations made pursuant to the Act also list these poisons.¹ Thus, all substances regulated under the Act are within the category of pharmaceuticals. No other poisons are regulated under this Act. Pharmaceuticals are divided into two categories: Pharmaceuticals not defined as poisonous, and only regulated generally under the Act, and pharmaceuticals defined as poisonous in two lists, and regulated more strenuously under the Act.

Section 3 creates a Pharmacy Board responsible for regulating standards of conducting any activities of pharmacists and for control of all dealings in pharmaceuticals and poisons. The Board's functions include registration of pharmacies by license; regulating the standard of conduct and activities of pharmacists and the practice of the profession of pharmacy; regulation of the manufacture, importation , labeling, marking or identification, storage and sale pharmaceuticals or any substances used in the manufacture of pharmaceuticals; to prescribe minimum standards of quality in respect of pharmaceuticals manufactured or imported into the United Republic (§4). Section 5 gives the Board power to cancel or suspend registrations. Sections 15-19 address the practice of pharmacy, by restricting certain activities of pharmacists. Part III of the Act governs manufacture of pharmaceuticals. Manufacturers of pharmaceuticals are required to hold a licence or be liable for fine of up to 20,000 Tsh. and/or up to five years imprisonment (§20). Premises must also be registered (§23) or violators are liable for 5,000 Tsh. and/or imprisonment up to 12 months.

Part IV of the Act regulates dealing in pharmaceutical and poisons. Specifically, section 25 gives the Minister authority to make regulations prescribing minimum standards to be complied with by manufacturers with regard to the composition of pharmaceuticals or their bacteriological or chemical standards. More specifically, the Minister may:

1. Require, prohibit or regulate the addition to a pharmaceutical, or extraction from the pharmaceutical, of any specified substance of any specified category, or the use of any substance as any ingredient in the manufacture or preservation of any pharmaceuticals or poisons;
2. Prohibit, restrict or regulate the importation or manufacture, or the sale, possession for sale or consignment or delivery of pharmaceuticals , or the ingredient of any pharmaceutical product or products, which do not comply with those regulations;
3. Prohibit or regulate the importation of any pharmaceutical product or category of pharmaceuticals, which in his opinion, is or may be prejudicial to public health;
4. Prohibit, restrict or regulate the importation of the use of any specified materials of any specified category, in the manufacture of apparatus or utensils designed for use in the preparation or preservation of pharmaceuticals for use by man;
5. Prescribe or provide for methods of analysis for the purpose of ascertaining the presence in any pharmaceutical product, or the absence from it, of any specified substance or quality of any substance present in the drug.

Section 26 prohibits preparation and sale of adulterated pharmaceuticals and §28 prohibits sale of pharmaceuticals unfit for use by man. Violators may be guilty of an offense. Importers of pharmaceuticals must be registered §30). Section 33 stipulates that "poisons" (more heavily restricted pharmaceuticals) shall be declared by the Board in a two-part list. "Part I of the list shall consist of poisons which, subject to this Act, shall not be sold except by an authorised seller of poison or a licensed wholesale dealer in mining, agricultural or horticultural accessories. Part II of the list shall consist of poisons which, subject to this Act, shall not be sold except by a person entitled to sell Part I poisons and by persons licensed under section 43." Part II is supposed to be restricted to those articles in use for other than the treatment of human ailments (e.g., veterinary purposes). Sections 35-44 delineate who can sell poisons from each list and to whom poisons may be sold and penalties for violation of these requirements for poisons are specified. Every poison shall be supplied in a container labeled in the prescribed manner:

1. With the name of the poison as one of its ingredients, with the prescribed particulars as to the proportion which the poison contained in the product bears to the total ingredients, and
2. With the word "poison" or other prescribed indication of the character of the article,
3. With the identification supplied on retail or other sale other than wholesale, including the name of the seller and the address of the premises on which it is sold, and
4. If supplied, but not on sale, with the name and address of the supplier.

Section 48 specifies labeling requirements for articles containing medicine, and delineates penalties for violation. Section 49-51 give restrictions on advertising. Part V of the Act spells out enforcement and legal proceedings, including power to take samples, right to have the sample analysed, provisions regarding the taking of samples for analysis, appointment and powers of inspectors, and the power of the Minister to control certain medicines. Finally, Part VI gives miscellaneous provisions, including power of the Ministers to make regulations regarding:

1. Prohibiting for retail sale any specified Part I poison except on a prescription lawfully given by a qualified medical practitioner, dentist or veterinary surgeon, and for prescribing the form and regulating the use of those prescriptions;
2. Prohibiting, regulating, or restricting the sale of Part II poisons or of any specified Part II poisons by any of the persons licensed under section 39 or section 43, or by any category of any those persons;
3. Excepting from any of the provisions of this Act relating to the sale of poisons any category of such articles or substances or for dispensing with or relaxing any provision contained in Part VI of this act with respect to poisons;
4. Providing for the better regulation of the manufacture, sales or advertising of the pharmaceuticals , poisons and therapeutic substances;
5. The safe custody, storage and transport pharmaceuticals and poisons;
6. The effective regulation of the importation, exportation, and labeling of pharmaceutical and poison;
7. The containers in which poison may be supplied;
8. The addition to poisons of specified ingredients for the purpose of rendering them readily distinguishable as poison;
9. The compound of poisons;
10. The manner, procedure and fees payable in respect of applications for licences or registration under this Act;
11. Prescribing, after consultation with the Board, the additional requirements relating to experience referred to in section 8(1)(c);
12. The conduct of inquiries by the Board, and the attendance of witnesses and production of evidence at inquiries under this Act, including the power to take evidence on oath;
13. Prescribing the grounds for suspension or cancellation of a license issued or registration granted under this Act;
14. Anything which is required or permitted to be prescribed or provided for under this Act.

1. See for example, GN 22/80 and GN 61/88.