Section 27(extract):
(2) A person who wishes to manufacture medicines shall apply in the prescribed form and pay the prescribed fee to the Authority, and shall supply any further information which the Authority may require to satisfy itself that the premises to be used are suitable for the purpose and will be operated in accordance with standards of good practice in the manufacture and quality control of medicines.
(3) The manufacture of medicines shall be under the continuous supervisory control of a registered pharmacist who possesses such practical experience as the Authority may prescribe.
(4) Where the Authority is satisfied that the conditions of any licence are not being observed, or that the manufacture of any medicine is not being carried out in accordance with the provisions of this Act or standards of good practice in the manufacture and quality control of medicines, the Authority may, after notice in writing to the licence holder, cancel the licence issued under this section.
(5) Where the Authority cancels a licence in terms of subsection (4), the licence holder shall cease all manufacturing.

Section 50:(extract):
(1) A person who uses a veterinary medicinal product on an animal under his or her care or uses medicated feed to feed an animal that he or she keeps in a feed lot or other premises, shall ensure that the animal is not slaughtered for consumption before the prescribed withdrawal period has elapsed, and the prescribed maximum residue limit allowable in meat has fallen within the limit allowed.
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(3) The Director of Veterinar Services may prescribe prohibited substances for use in animals.

Section 41:
Any medicine imported, manufactured or dispensed within Botswana shall be labelled in accordance with such requirements as the Authority may prescribe.

Regulation 49 (extract):
(2) The container of every medicine imported, manufactured, processed or packed in Botswana shall bear a label written in English, with the following information clearly indicated thereon-
(a) either the approved name of the medicine as used in official pharmacopoeias or formularies, or the international non-proprietary name;
(b) the brand name, if any;
(c) the contents of the container;
(d) the quantity of the active ingredients per dosage unit;
(e) the name of the manufacturer or applicant;
(f) the batch identification;
(g) the expiry date;
(h) any special storage conditions that may be necessary or desirable;
(i) any warnings or precautions that may be necessary or desirable;
(j) any directions for use if sold without prescription; and
(k) any appropriate statutory or restrictive direction or lable in terms of subregulation (6);
(l) any conditions or registration stipulated by the Authority during registration; and
(m) manufacture date.
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(6) The containers of pre-packed medicines shall bear the lable with the following -
(a) name, strength and quantity of the medicine;
(b) batch number;
(c) date of manufacture;
(d) exprity date ; and
(e) manufacturer.

Section 37 (extract):
(1) A person in possession of unwanted medicine shall dispose of the medicine in the manner prescribed by regulations.
(2) In this section, “unwanted medicine” means a medicine which has expired, is substandard, banned, or is a counterfeit.

Regulation 34 (extract):
(1) A person who dipsoses of medicines shall follow the guidelines and keep disposal certificates issued by the relevant authorities, for the Authority's inspection.
(2) The destruction of any Schedule 1A, Schedule 1B Schedule 1C medicines or precursors, in part or whole, shall be reported to the Authority in accordance with the guidelines and, except where the destruction is accidental, the destrcution shall be supervised by pahrmacist and witneessed by a police officer.
(3) A person shall dipsoe of unused medicines in a clinical trial in line with the guidelines.

Section 66 (extract):
(1) A person who contravenes the provisions of this Act or who-
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(c) otherwise contravenes the provisions of this Act for which a penalty is not provided, commits an offence and without prejudice to the person’s liability in terms of subsection (2), is liable to a fine of P10 000, or to a term of imprisonment not exceeding one year, or to both.
(2) Any person who imports, exports, manufactures, distributes, sells, dispenses, prescribes or advertises any medicine or other substance falsely purporting to be, or intended to or likely to induce anyone to a mistaken belief that it is a registered medicine, commits an offence and is liable to a fine of P100 000, or to imprisonment for 10 years, or to both.
(3) Where any person is convicted of an offence under this Act or any regulation made under it, the court may, at the request of the Authority, order any medicine or other substance in respect of which the offence was committed to be seized and disposed of as the Authority may require, and the Authority may at the same time withdraw any approval or authorisation previously given by the Authority to that person.

Regulation 71:
A person who -
(a) contravenes the provisions of these Regulations, for which no penalty is provided;
(b) fails to comply with any directions given or request made by the Authoryi or any competent authority under these Regulations; or
© fails to comply with any condidyions of a license.
commits an offence and liable to the penalties provided for under section 66 of the Act.