(a) Identity and specifications. The color additive D&C Red No. 7 shall conform in identity and specifications to the requirements of §74.1307 (a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 7 may be safely used for coloring

(a) Identity and specifications. The color additive D&C Red No. 21 shall conform in identity and specifications to the requirements of §74.1321(a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 21 may be safely used for coloring

(a) Identity and specifications. The color additive D&C Red No. 22 shall conform in identity and specifications to the requirements of §74.1322(a)(1) and (b). (b) Uses and restrictions. The color additive D&C Red No. 22 may be safely used for coloring

(a) Identity and specifications. The color additive D&C Red No. 27 shall conform in identity and specifications to the requirements of §74.1327 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 27 may be safely used for coloring cosmetics generally

(a) Identity and specifications. The color additive D&C Red No. 28 shall conform in identity and specifications to the requirements of §74.1328 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 28 may be safely used for coloring cosmetics generally

(a) Identity and specifications. The color additive D&C Red No. 30 shall conform in identity and specifications to the requirements of §74.1330 (a)(1) and (b). (b) Uses and restrictions. D&C Red No. 30 may be safely used for coloring cosmetics generally

(a) Identity and specifications. The color additive FD&C Yellow No. 6 shall conform in identity and specifications to the requirements of §74.706 (a)(1) and (b). (b) Uses and restrictions. FD&C Yellow No. 6 may be safely used for coloring cosmetics

(a) Identity and specifications. The color additive D&C Yellow No. 10 shall conform in identity and specifications to the requirements of §74.1710(a)(1) and (b). (b) Uses and restrictions. The color additive D&C Yellow No. 10 may be safely used for

§137.250(b)(2), except that a No. 20 standard sieve is used instead of a No. 12 sieve, not less than 95 percent passes through a No. 20 sieve, not less than 45 percent through a No. 25 sieve, but not more than 25 percent through No. 72 XXX grits gauze. Its moisture content is not more than 15 percent. (b) For the purposes of this section, moisture, fat and crude fiber are determined by methods therefor referred to in

) Ferrous fumarate is used as a source of iron in foods for special dietary use, when the use is consistent with good nutrition practice.

(b) Aminoglycoside 3′-phosphotransferase II is encoded by the kanr gene originally isolated from transposon Tn5 of the bacterium Escherichia coli. (c) The level of the additive does not exceed the amount reasonably required for selection of plant

Polyethylene glycol identified in this section may be safely used as a component of articles intended for use in contact with food, in accordance with the following prescribed conditions: (a) The additive is an addition polymer of ethylene oxide and water with a mean molecular weight of 200 to 9,500. (b) It contains no more than 0.2 percent total by weight of ethylene and diethylene glycols if its mean

ingredient is used as an indirect food ingredient with no limitations other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as an indirect human food ingredient is based upon the current good manufacturing practice of using this ingredient in the manufacture of paper and paperboard that contact food. (c) Prior sanctions for this ingredient different from the uses established in this section do not exist or

(a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. (b) Personnel shall practice good sanitation and health habits. (c) Only personnel authorized by supervisory

You must implement procedures to ensure that all equipment that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained, is clean, suitable for its intended purposes, properly installed, maintained, and capable of repeatedly producing valid results. You must document your activities in accordance with these procedures. (c)

(a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them. (b) This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act

(a) The management of the establishment must take reasonable measures and precautions to ensure that all persons working in direct contact with animal food, animal food-contact surfaces, and animal food-packaging materials conform to hygienic practices to the extent necessary to protect against the contamination of animal food. (b) The methods for conforming to hygienic practices and maintaining cleanliness include:

(a) An FDA Division Director in whose division the qualified facility is located (or, in the case of a foreign facility, the Director of the Division of Compliance in the Center for Veterinary Medicine), or an FDA official senior to either such Director, must approve an order to withdraw the exemption before the order is issued. (b) Any officer or qualified employee of FDA may issue an order to withdraw the exemption after it has been

Health and Human Services for official review and copying upon oral or written request. (d) The requirements of §507.206 apply only to the written food safety plan. (e) The requirements of §507.202(a)(2), (4), and (5) and (b) do not apply to

in dogs—(1) Amount. Administer orally 2 to 5 milligrams per pound of body weight once daily. (2) Indications for use. As a tranquilizer. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27

cats—(1) Amount. 5 micrograms per pound of body weight (0.25 milliliter per 10 pounds of body weight) by intravenous, intramuscular, or subcutaneous injection in dogs or by intramuscular injection in cats. (2) Indications for use. As a preanesthetic agent. (3) Limitations. Federal law restricts this drug to

(a) [Reserved] (b) Tolerances. The tolerances for erythromycin are: (1) Cattle. (i) Edible tissues (excluding milk): 0.1 ppm. (ii) Milk: Zero. (2) Chickens and turkeys.

(a) [Reserved] (b) Tolerances. The tolerances for sulfamethazine are: (1) Cattle. Edible tissues (excluding milk): 0.1 ppm. (2) Chickens and turkeys. Edible tissues (excluding eggs): 0.1 ppm. (3)

Natural substances used in conjunction with spices and other natural seasonings and flavorings that are generally recognized as safe for their intended use, within the meaning of section 409 of the act, are as follows: Open Table

) The cautionary statement placed in a prominent position on the label, “Do Not Use if Turbid. Do Not Begin Administration More Than 4 Hours After the Container Has Been Entered.”; (c) The need for additional fluids when 20 percent or 25 percent albumin is administered to a patient with marked dehydration; (d) The protein concentration, expressed as a 4 percent, 5 percent, 20 percent, or 25 percent solution.

(a) A class III certification submitted as part of a premarket notification shall state as follows: I certify, in my capacity as (position held in company), of (company name), that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety or effectiveness problems that have been reported for the (type of

(b) The following Hawaii medical device requirements are preempted by section 521(a) of the act, and the Food and Drug Administration has denied them exemption from preemption: Hawaii Revised Statutes, chapter 451A, §14.1, subsection (a) to the extent that it requires a written authorization by a physician and does not allow adults to waive this requirement for personal, as

(a) The following District of Columbia medical device requirements are enforceable, notwithstanding section 521 of the act, because the Food and Drug Administration has exempted them from preemption under section 521(b) of the act: (1) Act 2-79, section 5, to the extent that it requires an audiological evaluation for children under the age of 18. (2) Act 2-79, section 6, on the condition that in

Many devices classified in this part are intended to be used with a calibrator. A calibrator has a reference value assigned to it which serves as the basis by which test results of patients are derived or calculated. The calibrator for a device may be (a) manufactured and distributed separately from the device with which it is intended to be used, (b) manufactured and distributed as one of several device components, such as in a kit of reagents, or (c) built-in as an integral part of the

. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §862.9. [52 FR 16122, May 1, 1987, as amended at