Tap any paragraph to write a margin note. Your notes collect in the Desk below the text and file under cases with @. The side-by-side margin rail opens on a larger screen.

§
Marginalia
Code · CFR · Title 21 — Food and Drugs · Part 522 — Implantation or Injectable Dosage Form New Animal Drugs · § 522.1002

§ 522.1002. Follicle stimulating hormone.

393 words·~2 min read·/us/cfr/t21/s§ 522.1002

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)(1) Specifications. Each package contains 2 vials. One vial contains dry, powdered, porcine pituitary gland equivalent to 75 units (NIH-FSH-S1) of follicle stimulating hormone. The other vial contains 10 milliliters of aqueous diluent.
(2)Sponsor. See No. 052923 in § 510.600(c) of this chapter.
(3)Conditions of use—(i) Dosage. 12.5 units of follicle stimulating hormone twice a day for 3 days (a total of 75 units). To effect regression of the corpus luteum, prostaglandin should be given with the 5th dose.
(ii)Indications for use. For induction of superovulation in cows for procedures requiring the production of multiple ova at a single estrus.
(iii)Limitations. For intramuscular use in cows that are not pregnant and have a normal corpus luteum. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (b)(1) Specifications—(i) Single pack. Each package contains 2 vials. One vial contains 700 international units
(IU)porcine-pituitary-derived follicle stimulating hormone
(FSH)equivalent to 400 milligrams NIH-FSH-P1, as a dry powder. The other vial contains 20 milliliters
(mL)of bacteriostatic sodium chloride injection. When constituted, each milliliter of solution contains 35 IU FSH.
(ii)Dual pack. Each package contains 2 vials. Each vial contains 700 international units
(IU)porcine-pituitary-derived FSH equivalent to 400 milligrams NIH-FSH-P1, as a dry powder. Constitute with 20 mL bacteriostatic sodium chloride injection, using strict aseptic technique. When constituted, each milliliter of solution contains 35 IU FSH.
(2)Sponsor. See No. 017030 in § 510.600(c) of this chapter.
(3)Conditions of use—(i) Dosage. Administer 2.5 mL (87.5 IU) intramuscularly, twice daily at 12-hour intervals, for 4 consecutive days. In conjunction with the 6th dose, administer an approved prostaglandin product for cattle (cloprostenol sodium or dinoprost tromethamine), using the labeled dosage and administration instructions to cause luteolysis and induce estrus. See § 522.460 for use of cloprostenol sodium or § 522.690 for use of dinoprost tromethamine.
(ii)Indications for use. For the induction of superovulation in beef and dairy heifers and cows.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [58 FR 47377, Sept. 9, 1993, as amended at 62 FR 62242, Nov. 21, 1997; 76 FR 2808, Jan. 18, 2011; 79 FR 53136, Sept. 8, 2014; 79 FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, 2017; 82 FR 43484, Sept. 18, 2017]
Connections2 cite this
Citation graph
cites case law
§ 522.1002
Follicle stimulating hormone.
Fed. Reg.×2
Cites 0Cited by 2 across 1 source
★   the supreme law of the land   ★
Don't Tread on Me
E Pluribus Unum — out of many, one

"If you don't know your rights, you don't have any."

Marginalia · a citizen's law index
A research desk, not legal advice. Always read the cited source before relying on a summary.
Questions or an issue? support@self-law.org
disclaimerMarginalia is a research index, not a law firm. Nothing on this site is legal, tax, or financial advice and no attorney–client relationship is formed by using it. Statutes, regulations, and case law change; summaries, search results, AI output, and member posts may be incomplete, out of date, or wrong. Any interpretation drawn from material on this site should be validated by a licensed attorney in your jurisdiction before you act on it.