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348 Part 528—New Animal Drugs in Genetically § 526.1810 21 CFR Ch. I (4–1–14 Edition) slaughtered for food for 30 days fol- § 528.1070 Bc6 recombinant lowing udder infusion. deoxyribonucleic acid construct. [57 FR 37336, Aug. 18, 1992; 57 FR 42623, Sept. (a) Specifications and indications for 15, 1992; 79 FR 10973, Feb. 27, 2014] use. Five copies of a human Bc6 recom- binant deoxyribonucleic acid (rDNA) § 526.1810 Pirlimycin. construct located at the GTC 155–92 (a) Specifications. Each 10-milliliter site in a specific hemizygous diploid syringe contains 50 milligrams (mg) line of dairy breeds of domestic goats (Capra aegagrus hircus) directing the pirlimycin (as pirlimycin hydro- expression of the human gene for chloride). antithrombin (which is intended for (b) Sponsor. See No. 054771 in the treatment of humans) in the mam- § 510.600(c) of this chapter. mary gland of goats derived from lin- (c) Related tolerances. See § 556.515 of eage progenitor 155–92. this chapter. (b) Sponsor. See No. 042976 in § 510.600 (d) Conditions of use in cattle—(1) of this chapter. Amount. Infuse 50 mg into each infected (c) Limitations. Food or feed from quarter. Repeat treatment after 24 GTC–155–92 goats is not permitted in hours. Daily treatment may be re- the food or feed supply. peated at 24-hour intervals for up to 8 consecutive days. PART 529—CERTAIN OTHER DOS- (2) Indications for use. For the treat- AGE FORM NEW ANIMAL ment of clinical and subclinical mas- DRUGS titis in lactating dairy cattle associ- ated with Staphylococcus species such Sec. as Staphylococcus aureus and Strepto- 529.40 Albuterol. coccus species such as Streptococcus 529.56 Amikacin. agalactiae, Streptococcus dysgalactiae, 529.400 Chlorhexidine tablets and suspen- and Streptococcus uberis. sion. (3) Limitations. Milk taken from ani- 529.536 Detomidine. mals during treatment and for 36 hours 529.778 Doxycycline. following the last treatment must not 529.1030 Formalin. be used for food regardless of treat- 529.1044 Gentamicin in certain other dosage ment duration. Following infusion forms. 529.1044a Gentamicin solution for infusion. twice at a 24-hour interval, treated ani- 529.1044b Gentamicin solution for dipping mals must not be slaughtered for 9 eggs. days. Following any extended duration 529.1115 Halothane. of therapy (infusion longer than twice 529.1150 Hydrogen peroxide. at a 24-hour interval, up to 8 consecu- 529.1186 Isoflurane. tive days), animals must not be slaugh- 529.1350 Meloxicam. tered for 21 days. Federal law restricts 529.1660 Oxytetracycline. this drug to use by or on the order of a 529.1940 Progesterone intravaginal inserts. licensed veterinarian. 529.2150 Sevoflurane. 529.2464 Ticarcillin. [58 FR 58486, Nov. 2, 1993, as amended at 65 529.2503 Tricaine methanesulfonate. FR 61091, Oct. 16, 2000; 73 FR 811, Jan. 4, 2008; 529.2620 Triptorelin. 79 FR 10973, Feb. 27, 2014] AUTHORITY: 21 U.S.C. 360b. SOURCE: 40 FR 13881, Mar. 27, 1975, unless PART 528—NEW ANIMAL DRUGS IN otherwise noted. GENETICALLY ENGINEERED ANI- MALS § 529.40 Albuterol. (a) Specifications. A net weight of 6.7 AUTHORITY: 21 U.S.C. 360b. grams of formulated albuterol sulfate is supplied in a pressurized aluminum SOURCE: 74 FR 6823, Feb. 11, 2009, unless canister within an actuator system otherwise noted. equipped with a detachable nasal deliv- ery bulb. 348 VerDate Mar<15>2010 09:09 Aug 04, 2014 Jkt 232075 PO 00000 Frm 00358 Fmt 8010 Sfmt 8010 Y:\SGML\232075.XXX 232075 wreier-aviles on DSK5TPTVN1PROD with CFR.
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