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establishments under the same ownership or control, provided a serial letter is added in each case to identify each license and the products produced thereunder.

(d) When a license is issued for an establishment it shall not apply to more than one person at the same location, except that subsidiaries of the licensee, when named in the license, may operate thereunder at the establishment named. The licensee with its subsidiaries will be held responsible for all operations conducted in the licensed establishment.

(e) As of November 1 of each year or whenever requested by the Director, each licensee shall submit, through the office of the inspector in charge, a list of biological products with all their forms which are to be continued in production. Should the licensee discontinue production of some of the biological products named in his licenses, he shall return to the Division for termination all outstanding licenses covering such products, with a list of products with all their forms which he will continue to produce. Whenever a number of licenses issued at different times are outstanding they shall be returned to the Director at his request for consolidation.

(f) Every license outstanding on the effective date of the regulations which is in conflict therewith shall be returned for termination, with an application for a new license.

$ 102.5 Biological products; preparation by another licensee. No biological products authorized to be prepared in a licensed establishment shall be prepared in whole or in part by any other licensed establishment unless authorized in advance by the Director.

§ 102.6 Separation of establishments. Each licensed establishment shall be separate and distinct from any unlicensed establishment in which any biological product is prepared or handled.

§ 102.7 Special licenses. (a) Special licenses may be issued in particular cases for preparation of a biological product when, in the opinion of the Director, the laboratory and other research data and . other information available with respect to the product show that the product has value in the treatment of domestic animals but that the results of its use under a larger variety of conditions should be further evaluated prior to release under

a regular license. A special license for such a product may include any or all of the following requirements as may be prescribed by the Director to protect the livestock industry or other segments of the public:

(1) The product shall be prepared under Division inspection and tested in such manner as may be administratively determined by the Director.

(2) The applicant for a license shall currently file with the Director a statement of the substance of all claims proposed to be made for the product at any time while the product is under special license, and the product shall be recommended for use only under such conditions as the Director deems warranted by the laboratory and other research data and other information currently available concerning it.

(3) Where the nature of the product so requires for the protection of the public, the product shall be recommended for use only by trained personnel.

(4) No change shall be made in the composition or method of preparation of the product without prior approval of the Director.

(5) The licensee shall distribute the product in any State or other jurisdiction only in accordance with the requirements of such State or other jurisdiction.

(6) The licensee shall request the handlers to whom he distributes the product to (i) keep complete records showing the name and address of each purchaser of the product and the name, serial number and quantity of the product sold to such purchaser; (ii) furnish to each veterinarian, animal owner, or other person using the product, a report form, approved by the Division, which shall contain blank spaces for stating pertinent information concerning the results obtained from use of the product; and (iii) request users of the product to complete and return the report form to an official of the Department specified by the Director.

(b) Special licenses may include such other requirements as the Director may impose to protect the livestock industry and other segments of the public when the Director finds that adequate protection thereof will not be afforded by the requirements set forth in paragraph (a) of this section.

(c) Notice of all requirements to be imposed under paragraph (a) or paragraph (b) of this section shall be given to the applicant for license for any product under the act as soon as possible after it is determined that such product may be licensed only under special license, and the applicant shall be afforded an opportunity to present his views with respect to such requirements.

(d) Each applicant for a special license shall furnish all information required by other provisions of the regulations in this subchapter, and all provisions of such regulations in terms applicable to a product for which a special license has been or is to be issued shall apply to such product, except insofar as such provisions are inconsistent with any requirement under this section.

(e) Each applicant for a special license shall agree to distribute the product to be covered by the license only for such use as may be authorized under the license.

(f) Violation of any of the conditions of a special license shall constitute a violation of this section and may be grounds for suspension or revocation of the special license under § 102.51.

(g) Special licenses shall be converted to regular licenses as soon as field data and other available information justify the change.

§ 102.8 Instructions to licensee; products not prepared under license. When a license is issued, the inspector in charge shall furnish the licensee with a copy of the regulations. If the licensee, at the time the license is issued, has in the establishment any biological products which have not theretofore been prepared, and the containers of which have not theretofore been marked, in compliance with the regulations, the identity of the products shall be maintained, and they shall not be shipped or delivered for shipment from one State or Territory or the District of Columbia to another State or Territory or the District of Columbia, or otherwise dealt with as products prepared under the regulations. The licensee shall adopt and enforce all necessary measures and shall comply with all such directions as the Director may prescribe for carrying out the regulations. It shall be the responsibility of the licensee, irrespective of Division supervision, so to prepare and test each biological product, as set forth in the

regulations, that it will not be worthless, contaminated, dangerous, or harmful.

IMPORT PERMITS FOR BIOLOGICAL PRODUCTS

§ 102.26 Import permits required. Each person importing biological products shall hold an unexpired, unsuspended, and unrevoked permit issued by the Secretary.

§ 102.27 Application for import permit; requirements. (a) Each person desiring to import biological products shall make application in writing to the Secretary for a permit. The application shall specify the port or ports of entry at which the imported products will be cleared through the customs. Blank forms of application will be furnished upon request addressed to the Animal Inspection and Quarantine Division, Washington, D. C.

(b) Each application for a permit shall be accompanied by the affidavit of the actual manufacturer presented before an American consular officer, giving the name of the country, and the city, town or other location, where the biological products named therein are prepared, stating that said products are not worthless, contaminated, dangerous, or harmful, and stating whether the products were derived from animals, and, if so derived, the name of the species, and that such animals have not been exposed to any infectious or contagious disease, except as may have been essential in the preparation of the products and as specified in the affidavit.

(c) Each application for a permit shall be accompanied by the written consent of the actual manufacturer that properly accredited employees of the Department shall have the privilege of inspecting, without previous notification, and at such times as may be demanded by the aforesaid employees, all parts of the establishment at which such biological products were prepared, all processes of preparation, and all records relative to the preparation of such products.

(d) Each application for a permit shall be accompanied by information regarding all claims to be made on labels and in advertising matter used in connection with or related to the biological products to be imported, and a description of the methods of producing and testing the products used by the manufacturer. A permit will not be issued for the importation of any biological product unless written assurance is furnished that the

product will not be so advertised as to mislead or deceive the purchaser, and that the package or container in which the same is intended to be sold, bartered, exchanged, shipped, or imported will bear or contain no statement, design, or device which is false or misleading in any particular, and unless the product meets the applicable requirements of the regulations in Part 112 of this subchapter.

§ 102.28 Import permits; number, form, and termination. Permits shall be numbered and shall be in the following form:

UNITED STATES VETERINARY PERMIT NO.

BIOLOGICAL PRODUCTS
Washington, D. C.,

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Director, Animal Inspec

tion and Quarantine
Division

Each permit shall terminate at the end of the calendar year for which it is issued.

SUSPENSION OR REVOCATION OF LICENSES AND PERMITS; NOTICES RE DANGEROUS PRODUCTS

§ 102.51 Suspension ΟΤ revocation. (a) A license or permit issued under the Virus-Serum-Toxin Act may be formally suspended or revoked after opportunity for hearing has been accorded the licensee or permittee as provided in Part 123 of this subchapter, if the Secretary is satisfied that the license or permit is being used to facilitate or effect the preparation, sale, barter, exchange, shipment, or importation contrary to said act of any worthless, contaminated, dangerous,

or harmful biological product. Such use may be found to exist if:

(1) The construction of the establishment in which the biological product is prepared is defective, or the establishment is not conducted as required by the regulations;

(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;

(5) The license or permit is otherwise used to facilitate or effect the preparation, sale, barter, exchange, shipment, or importation, contrary to the VirusSerum-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, however, the Secretary may without hearing informally suspend such license or permit upon the grounds set forth in paragraph (a) of this section pending determination of formal proceedings under Part 123 of this subchapter for suspension or revocation of the license or permit.

§ 102.52 Notices re dangerous biological products. 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 license 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 license 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. ASSIGNMENT OF INSPECTORS AND FACILITIES § 102.76 Inspections of licensed establishments. (a) Any inspector shall be permitted to enter any establishment licensed under the regulations at any hour

during the day or night, and such inspector shall be permitted to inspect, without previous notification, the entire premises of the establishment, including all buildings, compartments, and other places, all biological products, and organisms and vectors in the establishment, and all equipment, such as chemicals, instruments, apparatus, and the like, and the methods used in the manufacture of, and all records maintained relative to, biological products at such establishment.

(b) Each inspector will be furnished with a numbered official badge, which he shall not allow to leave his possession. This badge shall be sufficient identification to entitle him to admittance at all regular entrances and to all parts of the licensed establishment and premises and to any place at any time for the purpose of making an inspection pursuant to paragraph (a) of this section.

§ 102.77 Facilities. When required by the Director or the Inspector in charge, the following facilities, and such others as may be essential to efficient conduct of inspection, shall be provided in each licensed establishment.

(a) Satisfactory pens, equipment, and assistance for conducting tests required in accordance with the regulations in this subchapter;

(b) The following special facilities in establishments producing anti-hogcholera serum and hog-cholera virus:

(1) Separate laboratory rooms for serum and virus,

(2) A separate room in which animals shall be washed and cleaned,

sary for holding biological products: Provided, That such rooms and compartments, and containers, and the like shall be capable of being secured under locks or seals furnished by the Division, and the keys of said locks shall not leave the custody of the inspectors;

(d) Suitable containers satisfactorily equipped for thoroughly mixing batches of all biological products; and

(e) Automatic recording thermometers or gages equipped for locking or sealing as provided in paragraph (c) of this section, and other thermometers which will register temperatures accurately and satisfactorily for use as required by the regulations.

§ 102.78 Overtime work at licensed establishments. The management of a licensed establishment desiring to work under conditions which will require the services of an employee of the Division on Saturday, Sunday, or a holiday, or for more than eight hours of any other day, shall sufficiently in advance of the period of overtime, request the inspector in charge or his assistant to provide inspection service during such overtime period, and shall pay the Administrator of the Agricultural Research Service an amount sufficient to reimburse the service for the cost of the inspection service so furnished. It will be administratively determined from time to time which days constitute holidays.

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(3) A separate room in which animals shall be finally prepared for bleeding or hyperimmunizing,

108.2

108.3

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§ 108.1

Remodeling and additions; 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 establishments. (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.

§ 108.7 Dangerous organisms and products. Rooms or compartments separate from the remainder of the establishment shall be provided at licensed establishments for preparing, handling, and storing virulent or dangerous organisms and products.

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$108.9 Dressing rooms and other facilities. (a) Each licensed establishment shall have dressing and toilet rooms and urinals sufficient in number, ample in size, conveniently located, properly ventilated, and meeting all requirements of the regulations as to sanitary construction and equipment. These rooms and facilities shall be separate from rooms and compartments in which any biological product is prepared, handled or stored.

(b) Each licensed establishment shall have modern lavatory accommodations, including running hot and cold water, soap, towels, and the like. These shall be so located in the establishments as to make them readily accessible to all persons handling biological products.

§ 108.10 Drainage and plumbing. There shall be an efficient drainage and plumbing system for each licensed establishment and premises thereof, and all drains and gutters shall be properly installed with approved traps and vents.

§ 108.11 Water supply. 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.

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§ 108.12 Rooms and equipment. 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 con

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