Permit means an emergency permit issued by the Commissioner pursuant to section 404 of the act for such temporary period of time as may be necessary to protect the public health. (e) Manufacture, processing, or packing of food in any locality means activities conducted in a single plant or establishment, a series of plants under a single management, or all plants in an industry or region, by a manufacturer

(a) You must make and keep records required under this subpart N in accordance with subpart P of this part. (b) You must make and keep the following records: (1) Written procedures for fulfilling the requirements of this subpart N. (2) Any material review and disposition decision on a returned dietary supplement; (3) The results of any

calendar days, before the beginning of operations in the next growing season, or within a reasonable timeframe, agreed to by FDA, based on a written justification, submitted to FDA, for a timeframe that exceeds 120 calendar days from the date of receipt of the order; or (b) Appeal the order within 15 calendar days of the date of receipt of the order in accordance with the requirements of

In the following conditions, among others, a food does not conform to the definition and standard of identity therefor: (a) If it contains an ingredient for which no provision is made in such definition and standard, unless such ingredient is an incidental additive introduced at a nonfunctional and insignificant level as a result of its deliberate and purposeful addition to another ingredient permitted by the terms of the applicable

reaction mixture meets the following specifications: (1) Not less than 90 percent butyl oleate. (2) Not more than 1.5 percent unsaponifiable matter. (b) The additive is used or intended for use at a level not to exceed 2 percent by weight in an aqueous emulsion in dehydrating grapes to produce raisins, whereby the residue of the additive on the raisins does not exceed 100 parts per million.

The food additive calcium chloride double salt of calcium pantothenate may be safely used in foods for special dietary uses in accordance with good manufacturing practice and under the following prescribed conditions: (a) The food additive is of the d (dextrorotatory) or the dl (racemic) form. (b) To assure safe use of the

Saponification number: 178-190 (b) It is used or intended for use as follows: (1) As an aid in crystallization of sucrose and dextrose at a level not to exceed the minimum quantity required to produce its intended effect. (2) As a surfactant in molasses at a level not to exceed 320 parts per million in the molasses.

additive is used or intended for use as follows: (1) As an emulsifier in polymer dispersions that are used in the clarification of cane or beet sugar juice or liquor in an amount not to exceed 7.5 percent by weight in the final polymer dispersion. (2) The additive is used in an amount not to exceed 0.70 part per million in sugar juice and 1.4 parts per million in sugar liquor. [51 FR 11720

level not to exceed 2.0 percent by weight: Provided, That, (1) The hops extract is added to the wort before or during cooking in the manufacture of beer. (2) The label of the hops extract specifies the presence of the isopropyl alcohol and provides for the use of the hops extract only as prescribed by paragraph (c)(1) of this section.

The regulations affecting special dietary foods (§105.3(e) of this chapter) define an infant as a child not more than 12 months old. Apart from this, the Food and Drug Administration has not established any definition of the term infant. Some question has arisen whether, for the purposes of drug labeling, an infant means a child up

(a) The label of prescription and insulin-containing drugs in package form shall bear as one of its principal features a statement of the identity of the drug. (b) Such statement of identity shall be in terms of the established name of the drug. In the case of a prescription drug that is a mixture and that has no established name, the requirement for statement of identity shall be deemed to be satisfied by a listing of the quantitative

The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient: (a) Brompheniramine maleate. (b) Chlorcyclizine hydrochloride. (c) Chlorpheniramine maleate. (d) Dexbrompheniramine maleate. (e) Dexchlorpheniramine maleate.

As used in this part: Astringent drug product. A drug product applied to the skin or mucous membranes for a local and limited protein coagulant effect. Lip protectant drug product. A drug product that temporarily prevents dryness and helps relieve chapping of the exposed surfaces of the lips; traditionally called “lip balm

(a) The transcript and record shall be certified by the Commissioner. In any case in which the Commissioner enters an order without a hearing pursuant to §314.200(g) of this chapter, the request(s) for hearing together with the data and information submitted and the Commissioner's findings and conclusions shall be included in the record certified by the Commissioner

Amount. 3 micrograms per kilogram (1.36 micrograms per pound) of body weight. (2) Indications for use. To prevent infection by the canine heartworm Dirofilaria immitis and the subsequent development of canine heartworm disease. (3) Limitations. Federal law restricts this drug to use by or on the order of

§510.600 of this chapter. (c) Indications for use. Significantly more of these Atlantic salmon grow to at least 100 grams within 2,700 Celsius degree-days than their comparators. (d) Limitations. These Atlantic salmon are produced as eyed-eggs and grown-out only in physically-contained

(b) If FDA determines that an extralabel drug use in animals not intended for human consumption presents a risk to the public health, the agency may publish in the Federal Register a notice prohibiting such use following the procedures in §530.25. The prohibited extralabel drug use will be codified in

(a) [Reserved] (b) Tolerances. The tolerances for thiabendazole are: (1) Cattle. (i) Edible tissues (excluding milk): 0.1 ppm. (ii) Milk: 0.05 ppm. (2) Swine. Edible tissues: 0.1

. (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 cells carrying the

Sodium nitrite may be safely used in canned pet food containing meat and fish in accordance with the following prescribed conditions: (a) It is used or intended for use alone as a preservative and color fixative in canned pet food containing fish, meat, and fish and meat byproducts so that the level of sodium nitrite does not exceed 20 parts per million. (b) To assure safe use of the additive, in

(a) Bithionol has been used to some extent as an antibacterial agent in cosmetic preparations such as detergent bars, shampoos, creams, lotions, and bases used to hide blemishes. New evidence of clinical experience and photopatch tests indicate that bithionol is capable of causing photosensitivity in man when used topically and that in some instances the photosensitization may persist for prolonged periods as severe reactions without further contact with sensitizing

retain documentation of these reports in your MDR files for the time periods specified in §803.18. (2) You are a manufacturer or importer and you did not manufacture or import the device about which you have adverse event information. When you receive reportable event information in error, you must forward this information to us with a cover letter explaining that you

(b) Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §864.9. [45 FR 60637, Sept. 12, 1980, as amended at

(a) Identification. An enriched culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify fastidious microorganisms (those having complex nutritional requirements). The device consists of a relatively simple basal medium enriched by the addition of such nutritional components as blood, blood serum, vitamins, and extracts of plant or animal

(a) Identification. A selective culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify certain pathogenic microorganisms. The device contains one or more components that suppress the growth of certain microorganisms while either promoting or not affecting the growth of other microorganisms. The device aids in the diagnosis of disease

. This organism is responsible for a variety of inflammations of the skin following skin abrasions from contact with fish, shellfish, or poultry. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in

detect the presence of Neisseria spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Neisseria, such as epidemic cerebrospinal meningitis, meningococcal disease, and gonorrhea, and also provides epidemiological information on diseases caused by these microorganisms. The device does not include products for the detection of gonorrhea in humans

(a) Identification. Rocket immunoelectrophoresis equipment for clinical use is a device used to perform a specific test on proteins by using a procedure called rocket immunoelectrophoresis. In this procedure, an electric current causes the protein in solution to migrate through agar gel containing specific antisera. The protein precipitates with the antisera in a rocket-shaped pattern, giving the name to the device. The height

(a) Identification. A preformed tooth positioner is a plastic device that is an impression of a perfected bite intended to prevent a patient's teeth from shifting position or to move teeth to a final position after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position.

(a) Identification. A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin