Food and Drug Regulations

C.01.032 No person shall sell a corticosteroid drug for ophthalmic use unless

• (a) the outer label or the package insert carries, as part of the directions for use, the following statements:

  “Contraindications

  Viral diseases of the cornea and conjunctiva;

  Tuberculosis of the eye;

  Fungal diseases of the eye;

  Acute purulent untreated infections of the eye, which, like other diseases caused by micro-organisms, may be masked or enhanced by the presence of the steroid.

  Side Effects

  Extended ophthalmic use of corticosteroid drugs may cause increased intraocular pressure in certain individuals and in those diseases causing thinning of the cornea, perforation has been known to occur.”;

  and

• (b) the inner label carries the statements required by paragraph (a) or instructions to see the outer label or package insert for information about contraindications and side effects.