SPS 10.03(2)(m)(m) Any drug or device that is used for an ophthalmic therapeutic purpose and that is the subject of a new drug application approved by the food and drug administration under section 505 (c) (1) of the federal food, drug and cosmetic act, 21 USC 355, as amended. SPS 10.03(2)(n)(n) Any drug or device that is used for an ophthalmic therapeutic purpose and that is generally exempt from the new drug application approval requirement contained in section 505 of the federal food, drug and cosmetic act, 21 USC 355, as amended.