The food additive calcium lactobionate may be safely used in food in accordance with the following prescribed conditions: (a) The food additive is the calcium salt of lactobionic acid (4-(β,D-galactosido)-D-gluconic acid) produced by the oxidation of lactose. (b) It is used or intended for use as a firming agent in dry pudding mixes at a level not greater than that required to accomplish the intended

Tamarind seed kernel powder may be safely used as a component of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. (a) Tamarind seed kernel powder is the ground kernel of tamarind seed (Tamarindus indica L.) after removal of the seed coat.

(a) Product. Sodium carboxymethylcellulose is the sodium salt of carboxymethylcellulose not less than 99.5 percent on a dry-weight basis, with maximum substitution of 0.95 carboxymethyl groups per anhydroglucose unit, and with a minimum viscosity of 25 centipoises for 2 percent by weight aqueous solution at 25 °C. (b) Conditions of use. This substance is

There are presently no regulations under the Federal Food, Drug, and Cosmetic Act that prevent a manufacturer of prescription drugs from sending the pharmacist data he needs on indications and dosage in exercising his important professional function of checking against possible mistakes in a prescription. The Food and Drug Administration believes manufacturers should be encouraged to supply such printed matter to the pharmacist for his professional information. Obviously, such printed matter

imported or offered for import into the United States.

Distribution records shall contain the name and strength of the product and description of the dosage form, name and address of the consignee, date and quantity shipped, and lot or control number of the drug product. For compressed medical gas products, distribution records are not required to contain lot or control numbers. (Approved by the Office of Management and Budget under control number 0910-0139)

Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant

(a) An over-the-counter anthelmintic drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this subpart and each general condition established in §330.1. (b) References in this subpart to regulatory sections of the Code of Federal

An approved new animal drug or human drug intended to be used for an extralabel purpose in an animal is not unsafe under section 512 of the act and is exempt from the labeling requirements of section 502(f) of the act if such use is: (a) By or on the lawful written or oral order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship; and (b) In compliance with

(a) [Reserved] (b) Tolerances. The tolerance for amoxicillin is: (1) Cattle. Edible tissues: 0.01 ppm. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerance for quinoxaline-2-carboxylic acid (marker residue) is: (1) Swine. Liver (target tissue): 30 ppb. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerance for carbomycin is: (1) Chickens. Edible tissues (excluding eggs): Zero. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerance for chlorhexidine is: (1) Cattle. Edible tissues (excluding milk): Zero. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerance for colistimethate is: (1) Chickens. Edible tissues (excluding eggs): Not required. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerance for dichlorvos is: (1) Swine. Edible tissues: 0.1 ppm. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerance for fenthion is: (1) Cattle. Edible tissues (excluding milk): 0.1 ppm. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerance for haloxon is: (1) Cattle. Edible tissues (excluding milk): 0.1 ppm. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerance for maduramicin (marker residue) is: (1) Chickens. Fat (target tissue): 0.38 ppm. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerance for metoserpate is: (1) Chickens. Edible tissues (excluding eggs): 0.02 ppm. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerance for poloxalene is: (1) Cattle. Edible tissues (excluding milk): Not required. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerance for sulfachloropyrazine is: (1) Chickens. Edible tissues (excluding eggs): Zero. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerances for sulfachlorpyridazine are: (1) Cattle and swine. Edible tissues (excluding milk): 0.1 ppm. (2) [Reserved] (c) Related conditions of use. See

(a) [Reserved] (b) Tolerances. The tolerances for sulfomyxin are: (1) Chickens and turkeys. Edible tissues (excluding eggs): Zero. (2) [Reserved] (c) Related conditions of use. See

(a) Product. Sodium carboxymethyl- cellulose is the sodium salt of carboxymethylcellulose not less than 99.5 percent on a dry-weight basis, with maximum substitution of 0.95 carboxymethyl groups per anhydroglucose unit, and with a minimum viscosity of 25 centipoises for 2 percent by weight aqueous solution at 25 °C. (b) Conditions of use. This substance is

(a) Whole blood donors must meet the criteria for eligibility prescribed in §§630.10 and 630.15 of this chapter. (b) Collection establishments must determine the eligibility of plasmapheresis donors in accordance with §§630.10 and 630.15 of

Either the manufacturer, packer, or distributor of a cosmetic product is requested to file Form FDA 2512 (“Cosmetic Product Ingredient Statement”), whether or not the cosmetic product enters interstate commerce. This request extends to any foreign manufacturer, packer, or distributor of a cosmetic product exported for sale in any State as defined in section 201(a)(1) of the Federal Food, Drug, and Cosmetic Act. No filing fee is required.

(a) Identification. A red cell indices device, usually part of a larger system, calculates or directly measures the erythrocyte mean corpuscular volume (MCV), the mean corpuscular hemoglobin (MCH), and the mean corpuscular hemoglobin concentration (MCHC). The red cell indices are used for the differential diagnosis of anemias. (b) Classification. Class II

(a) Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene). (b) Classification.

(a) Identification. A hyperbaric chamber is a device that is intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient's tissue by means of pressurization that is greater than atmospheric pressure. This device does not include topical oxygen chambers for extremities (

(a) Identification. A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line. (b