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§558.575. Sulfadimethoxine and ormetoprim.

21 C.F.R. § 558.575

(a)
Specifications. Type A medicated articles containing either:
(1)
25 percent sulfadimethoxine and 15 percent ormetoprim; or
(2)
25 percent sulfadimethoxine and 5 percent ormetoprim.
(b)
Sponsors. See sponsors in § 510.600(c) of this chapter as follows:
(1)
No. 054771 for use of the product described in paragraph (a)(1) as in paragraphs (e)(1), (e)(2)(i), and (e)(3)(i) through (iii) of this section.
(2)
No. 015331 for use of the product described in paragraph (a)(2) as in paragraphs (e)(3)(iv) and (v) of this section.
(c)
Related tolerances. See §§ 556.490 and 556.640 of this chapter.
(d)
Special considerations.
(1)
Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.
(2)
The expiration date of VFDs for sulfadimethoxine and ormetoprim medicated feeds must not exceed 6 months from the date of issuance. VFDs for sulfadimethoxine and ormetoprim shall not be refilled.
(e)
Conditions of use. It is used in animal feeds as follows:
(1)
Chickens—
(2)
Turkeys—
(3)
Minor species—
Notes, amendments, and revision history

Amendments

[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 13550, Mar. 11, 1977; 49 FR 33442, Aug. 23, 1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400, Mar. 3, 1986; 51 FR 18884, May 23, 1986; 52 FR 2686, Jan. 26, 1987; 54 FR 1686, Jan. 17, 1989; 63 FR 27846, May 21, 1998; 64 FR 26672, May 17, 1999; 64 FR 43910, Aug. 12, 1999; 66 FR 46707, Sept. 7, 2001; 70 FR 52292, Sept. 2, 2005; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; 81 FR 95013, Dec. 27, 2016; 83 FR 13637, Mar. 30, 2018; 84 FR 12502, Apr. 2, 2019; 86 FR 14827, Mar. 19, 2021; 87 FR 76424, Dec. 14, 2022; 91 FR 20347, Apr. 16, 2026]

Authority

Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

Source

Source: 40 FR 13959, Mar. 27, 1975, unless otherwise noted.

Amendments

[40 FR 13959, Mar. 27, 1975, as amended at 42 FR 13550, Mar. 11, 1977; 49 FR 33442, Aug. 23, 1984; 49 FR 46371, Nov. 26, 1984; 51 FR 7400, Mar. 3, 1986; 51 FR 18884, May 23, 1986; 52 FR 2686, Jan. 26, 1987; 54 FR 1686, Jan. 17, 1989; 63 FR 27846, May 21, 1998; 64 FR 26672, May 17, 1999; 64 FR 43910, Aug. 12, 1999; 66 FR 46707, Sept. 7, 2001; 70 FR 52292, Sept. 2, 2005; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; 81 FR 95013, Dec. 27, 2016; 83 FR 13637, Mar. 30, 2018; 84 FR 12502, Apr. 2, 2019; 86 FR 14827, Mar. 19, 2021; 87 FR 76424, Dec. 14, 2022; 91 FR 20347, Apr. 16, 2026]