Food and Drug Regulations
C.01.015 (1) Subject to subsection (2), no person shall sell for human use a drug in the form of a tablet that is intended to be swallowed whole unless, when tested by the official method DO-25, Determination of the Disintegration Time of Tablets, dated July 5, 1989,
(a) in the case of an uncoated tablet, the tablet disintegrates in not more than 45 minutes;
(b) in the case of a plain coated tablet, the tablet disintegrates in not more than 60 minutes; and
(c) in the case where the label of the drug indicates that the tablet carries an enteric coating or a coating designed to serve a purpose similar to that of an enteric coating, the tablet does not disintegrate when exposed for 60 minutes to simulated gastric fluid, but when it is subsequently exposed for a continuous period to simulated intestinal fluid, the tablet disintegrates in not more than 60 minutes.
(2) Subsection (1) does not apply in respect of a drug in the form of a tablet where
(a) a notice of compliance in respect of the drug in the form of a tablet has been issued pursuant to section C.08.004;
(b) [Repealed, SOR/98-423, s. 7]
(c) a dissolution or disintegration test for the drug in the form of a tablet is prescribed in Division 6 of this Part;
(d) the drug is labelled as complying with a standard contained in a publication referred to in Schedule B to the Act;
(e) the drug has been demonstrated by an acceptable method to be available to the body; or
(f) representations regarding the drug are made on its label, or in any advertisement, with respect to the site, rate or extent of release to the body of a medicinal ingredient of that drug, or the availability to the body of a medicinal ingredient of that drug.
- SOR/89-429, s. 2;
- SOR/89-455, s. 3;
- SOR/94-36, s. 2;
- SOR/98-423, s. 7.
- Date modified: