ment is not conducted as required by the regulations in Parts 101 through 121 of this subchapter;

(2) The methods of preparation of the product are faulty, or the product contains impurities or lacks potency;

(3) The product is so labeled or advertised as to mislead or deceive the purchaser in any particular;

(4) The licensee or permittee has violated or failed to comply with any provision of the Virus-Serum-Toxin Act or the regulations in Parts 101 through 121 of this subchapter;

(5) The license or permit is otherwise used to facilitate or effect the preparation, sale, barter, exchange, shipment, or importation, contrary to the Virus-Serum-Toxin Act, of any worthless, contaminated, dangerous, or harmful biological product.

(b) In case of willfulness or where the public health, interest, or safety so requires the Secretary may, without hearing, informally suspend such establishment license, product license, special license, or permit upon the grounds set forth in paragraph (a) of this section pending determination of formal proceedings under Part 123 of this sub=chapter for suspension or revocation of the license or permit.

§ 102.52 Notices re worthless, contaminated, dangerous, or harmful biological products.

(a) If at any time it appears that the preparation, sale, barter, exchange, shipment, or importation, as provided in the Virus-Serum-Toxin Act, of any biological product by any person holding a li1cense or permit may be dangerous in the treatment of domestic animals, the Secretary may without hearing notify the licensee or permittee, and pending determination of formal proceedings instituted under Part 123 of this subchapter for suspension or revocation of the li*cense or permit insofar as it authorizes the manufacture or importation of the particular product, no person so notified shall thereafter so prepare, sell, barter, exchange, ship, deliver for shipment, or import such product.

(b) If a serial of biological product is found to be unsatisfactory according to applicable Standard Requirements, the Director may notify the licensee to stop distribution and sale of the serial.

PART 103-EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING

Sec.

103.1

Preparation of experimental biological products.

103.2 Disposition of animals administered experimental biological products or live organisms.

103.3 Distribution of experimental biological products.

AUTHORITY: The provisions of this Part 103 issued under 37 Stat. 832-833; 21 U.S.C. 151-158.

§ 103.1 Preparation of experimental biological products.

Except as otherwise provided in this section, experimental biological products which are neither composed of nor prepared with organisms or antigens used in biologicals already licensed, shall not be prepared in the production facilities of a licensed establishment. Upon application therefor, the Director may authorize the preparation of experimental products on the premises of a licensed establishment if he determines that such preparation will not result in contamination of the licensed products. Each request for permission to prepare an experimental biological product on licensed premises shall indicate the nature of the unlicensed product, designate facilities to be used, and specify precautions which will be taken to prevent contamination of licensed products. Such requests shall be submitted to the Director. Research facilities that are entirely separate and apart from facilities used for the preparation of licensed biological products will not be considered a part of the licensed premises for purposes of this section. [30 F.R. 11848, Sept. 16, 1965]

after administration of an experimental biological product or live organisms: Provided, however, That this holding period may be increased or decreased as permitted or required by the Director following review of all relevant information or data available.

(b) All animals administered experimental biological products which are to be slaughtered at establishments subject to the Meat Inspection Act, as amended and extended (21 U.S.C. 71-91, 96) are subject to the applicable requirements of § 309.20 of this title (Meat Inspection Regulations).

(c) Except as otherwise provided in this paragraph, the research investigator or research sponsor shall maintain adequate records relative to the disposition of each animal administered experimental biological products. These records shall be maintained for a minimum period of two years from the date that an experimental product was administered to such animal, and shall show the name and address of the owner; number, species, class and location of the animals; and if sold, the name and address of the consignee, buyer, commission firm or abattoir: Provided, however, That a research investigator or research sponsor may be exempted from these recordkeeping requirements by the Director on the basis of acceptable data demonstrating that use of the experimental biological product will not result in the presence of any unwholesome condition in the edible parts of animals subsequently presented for slaughter.

[30 F.R. 11848, Sept. 16, 1965]

§ 103.3 Distribution of experimental biological products.

Except as provided in this section, no person shall ship or deliver for shipment from one State or Territory or the District of Columbia to any other State or Territory or the District of Columbia any unlicensed biological product for experimental treatment of domestic animals. For the convenience of license applicants and to permit and encourage important research projects, a person may be authorized by the Director to ship unlicensed biological products from one State or Territory or the District of Columbia to another State or Territory or the District of Columbia, for the pur

(a) One copy of permit or letter of permission from the proper State authorities of each State involved;

(b) Two copies of a tentative list of the names of the proposed recipients and quantity of experimental product that is to be shipped to each individual. 1 In the event of subsequent changes, additional information shall be furnished when such facts are known;

(c) Two copies of a description of the product, recommendations for use, and results of preliminary research work;

(d) Three copies of labels or label sketches which show the name or identification of the product and bear a statement, "Notice! For Experimental Use Only-Not For Sale," or equivalent. The U.S. Veterinary License legend shall not appear on such labels; and

(e) Two copies of a proposed general plan covering the methods and procedures for evaluating the product and for maintaining records of the quantities of experimental product prepared, shipped and used. At the conclusion of field studies, results shall be obtained, summarized, and submitted to the Division.

(f) Data acceptable to the Director demonstrating that use of the experimental biological product in meat animals is not likely to result in the presence of any unwholesome condition in the edible parts of animals subsequently presented for slaughter.

(g) A statement from the research investigator or research sponsor agreeing to furnish, upon the Director's request, additional information concerning each group of meat animals involved prior to movement of these animals from the premises where the test is to be conducted. Such information shall inIclude the owner's name and address; number, species, class and location of

plans and specifications. Triplicate copies of plans properly drawn to scale, and of specifications, including plumbing and drainage, for remodeling licensed establishments and for new structures at licensed establishments shall be submitted to the Director in advance of construction. § 108.2

Stables and premises.

Stables or other premises for animals used in the production or testing of biological products at licensed establishments shall be properly ventilated and lighted, appropriately drained and guttered, and kept in sanitary condition. § 108.3 Segregation of animals.

Animals infected with or exposed to any dangerous, infectious, contagious, or communicable disease shall be effectively segregated at licensed establishments.

§ 108.4 Location of licensed establish

ments.

(a) Licensed establishments shall be so located and so constructed that disease will not spread therefrom, and suitable arrangements shall be made for the disposal of all refuse.

(b) Direct communication to licensed establishments shall not be maintained from public stockyards, abattoir pens, or other places in which animals are received or held for any purpose.

§ 108.5 Precautions.

All biological products prepared at licensed establishments shall be prepared, handled, and distributed under the Virus-Serum-Toxin Act with due sanitary precautions, and all such biological products to be shipped or delivered under said act shall be securely packed. § 108.6 Construction.

The floors, walls, ceilings, partitions, posts, doors, and all other parts of all structures at licensed establishments shall be of such material, construction, and finish as can be readily and thoroughly cleaned.

The supply of hot and cold water at licensed establishments shall be ample and clean. Adequate facilities shall be provided for the distribution of water in each establishment and for the washing of all containers, machinery, instruments, other equipment, and animals used in the preparation, handling, or storing of any biological product.

§ 108.12 Rooms and equipment.

All rooms, compartments, and other places used in connection with the preparation, handling, or storing of any biological product at licensed establishments shall be of such material, construction, and design as can be readily and thoroughly cleaned. All containers, instruments, and other equipment shall be cleaned and sterilized and so handled thereafter as to afford protection from contamination. Containers, instruments, and other apparatus and equipment used for preparing, handling, or storing virulent or dangerous organisms or products shall not be used for handling, preparing, or storing other forms of biological products.

§ 108.13 Hands and clothing.

(a) All employees of licensed establishments who handle biological products shall keep their hands and clothing clean. The hands of such employees shall not come in contact with any biological product or with any part of sterilized containers, instruments, or other equipment which may come in contact with such products.

(b) Caps, gowns, and other outer clothing worn by persons while handling any biological product shall be of clean, white material whenever practicable.

The outer premises of licensed establishments, embracing docks, driveways, approaches, yards, pens, chutes, and alleys, shall be drained properly and kept in a clean and orderly condition. No nuisance shall be allowed in any licensed establishment or on its premises. § 108.15 Flies and other vermin.

Every practicable precaution shall be taken to keep licensed establishments free of flies, rats, mice, and other vermin. The accumulation, on the premises of an establishment, of any material in which flies or other vermin may breed is forbidden.

§ 109.1

Equipment and the like.

(a) All containers, instruments, and other apparatus and equipment, before being used in preparing, handling, or storing biological products, at a licensed establishment, except as otherwise prescribed herein, shall be thoroughly sterilized by live steam at a temperature of at least 120° C. for not less than one-half hour, or by dry heat at a temperature of at least 160° C. for not less than one hour. If for any reason such methods of sterilization are impracticable, then a process known to be equally efficacious in destroying microorganisms and their spores may be substituted after approval by the Director.

(b) Instruments which are found to be damaged by exposure to the degree of heat prescribed in this section, after having been thoroughly cleaned, may be sterilized by boiling for not less than 15 minutes, provided apparatus satisfactory to the inspector in charge is furnished for this purpose.

censed establishment or imported by a permittee, in compliance with the regulations for the purpose of sale, barter, exchange, or commercial distribution, and found not to be worthless, contaminated, dangerous, or harmful, shall be labeled and packaged as provided in this part, before it is removed from the licensed establishment or presented for importation.

(b) No container of any biological product may be labeled until it has been tested and found to be not worthless, contaminated, dangerous, or harmful. The Director may permit labeling in advance if in his opinion adequate precautions to prevent marketing of untested products are taken by the licensee.

(c) No person shall apply or affix, or cause to be applied or affixed, any label, stamp, or mark to any biological product prepared or received in a licensed establishment or imported except in compliance with the regulations. Suitable tags or labels of a distinct design shall be used for identifying all biological products while in course of preparation at licensed establishments.

[23 F.R. 10051, Dec. 23, 1958, as amended at 26 F.R. 7727, Aug. 18, 1961; 30 F.R. 920, Jan. 29, 1965]

§ 112.2 Required and permitted informa. tion.

(a) Except as provided by the Director, each label of a biological product prepared at a licensed establishment or imported shall include the following:

(1) The true name of the product which name shall be identical with that shown in the license or permit under which the product is prepared or imported and shall be prominently lettered and placed giving equal emphasis to each word composing it;

(2) In the case of product manufactured in the United States, the name and address of the licensee, or of the subsidiary which manufactured the product, when named in the license as provided in § 102.4 (d) of this subchapter, and in the case of foreign-manufactured product offered for importation, the name and address of the permittee and of the foreign manufacturer: Provided, That when the licensee has more than one establishment, one street address only shall be given, although the gen