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sample required hereunder which includes such material as an ingredient or component of an ingredient, unless and until the person requesting certification makes an adequate showing that the cause for such refusal no longer exists.

effectiveness of such certifications as are set forth in $429.45(a) (1) and (b) (4).

(d) For the purposes of his investigations under the authority of this section, the Commissioner may accept, when he is satisfied as to the completeness and accuracy thereof, the results of any tests or assays made by the control laboratory of the Insulin Committee of the University of Toronto.

[39 FR 11750, Mar. 29, 1974, as amended at 39 FR 40286, Nov. 15, 1974; 44 FR 48968, Aug. 21, 1979; 44 FR 55170, Sept. 25, 1979; 45 FR 40111, June 13, 1980; 50 FR 8996, Mar. 6, 1985; 55 FR 11582, Mar. 29, 1990]

8 429.45 Conditions on the effective

ness of certificates.

429.41 Certifications.

(a) If it appears to the Commissioner, after such investigation as he considers necessary, that:

(1) The information (including results of tests and assays) and the samples required by or pursuant to 8 429.40 have been submitted, and such information contains no untrue statement of a material fact;

(2) The batch complies with the regulations in this part 429 and conforms to the standards of identity, quality, strength, and purity for insulin injection, protamine zinc insulin suspension, globin zinc insulin injection, isophane insulin suspension, insulin zinc suspension, prompt insulin zinc suspension, or extended insulin zinc suspension; the Commissioner shall certify that such batch is safe and efficacious for use, subject to such conditions on the effectiveness of such certifications as are set forth in $ 429.45, and shall issue to the person who requested it a certificate to that effect.

(b) If the Commissioner determines, after such investigation as he considers to be necessary, that the information submitted pursuant to $ 429.40 or the batch covered by such request, does not comply with the requirements set forth in paragraph (a) of this section for the issuance of a certificate, the Commissioner shall refuse to certify such batch and shall give notice thereof to the person who requested certification,

ating his reasons for refusal.

(c) Upon the request of the manufacturer, the Commissioner shall certify as a “batch” a master lot, which has been approved in accordance with $ 429.40(j) as safe and efficacious for use in preparation of an insulin-containing drug, subject to the conditions on the

(a) A certificate shall not become effective:

(1) If it is obtained through fraud, or through misrepresentation or concealment of a material fact.

(2) With respect to any package, unless its immediate container complies with the requirements of $429.10 and such package or such immediate container has been so sealed that its contents cannot be used without destroying such package or seal.

(3) With respect to any package, unless its label and labeling bear all words, statements, and other information, and are distinguished by the color or colors, required by $$ 429.11 and 429.12.

(b) A certificate shall cease to be effective: (1) With respect to any package of insulin injection, protamine zinc insulin suspension, globin zinc insulin injection, isophane insulin suspension, insulin zinc suspension, prompt insulin zinc suspension, or extended insulin zinc suspension on the expiration date specified in the U.S.P.

(2) With respect to any package, when such package or the seal thereof or the immediate container therein or the seal of the immediate container is broken, or when its label or labeling ceases to conform to any requirement of $ 429.11 or $429.12.

(3) With respect to any package, when the drug therein so changes that it fails to meet the standards of identity, strength, quality, and purity upon the basis of which the batch was certified; except that those minor changes in potency (not exceeding 10 percent from the potency stated on the label, in the case of insulin injection) which occur before the expiration date, and which are normal and unavoidable in good storage and distribution practice, shall be disregarded.

(4) With respect to a master lot of insulin, 5 years after date of issue if the master lot is a solution, or 10 years after date of issue if the master lot is a solid.

(39 FR 11750, Mar. 29, 1974, as amended at 39 FR 40286, Nov. 15, 1974)

8 429.47 Authority to refuse certifi

cation service.

When the Commissioner finds, after giving notice and opportunity for hearing, that a person has:

(a) Obtained or attempted to obtain a certificate through fraud, or through misrepresentation or concealment of a material fact;

(b) Falsified the records required to be kept by $429.60; or

(c) Failed to keep such records or to make them available, or to accord full opportunity to make an inventory of stocks on hand or otherwise to check the correctness of such records, as required by such section; the Commissioner may immediately suspend service to such person under the regulations in this part, and may continue such suspension unless and until such person shows adequate cause why such suspension should be terminated.

all circumstances and contingencies, warrants a refund from the fund collected during such period, he shall make ratable refunds to those persons to whom the services were rendered and charged.

(b) The fees for requests for certification submitted under $429.40 are as follows:

(1) $2,400 for each master lot or mixture of two or more master lots or parts thereof.

(2) $1,700 for each dosage form batch.

(3) The fees established in this paragraph may increase as Federal salary costs increase. The rate of increase will be no higher than Federal salary increases, commencing with pay rais on or after January 1, 1997. Notification of the exact fees established and adjustments will be communicated directly to the manufacturers of insulin products.

(c) A person requiring continuing certification services may maintain an advance deposit of the estimated costs of such services for a period of 2 months or more. Such deposits shall be debited with fees for services rendered, but shall not be debited for any fee the amount of which is not definitely specified in these regulations unless the depositor has previously requested the performance of the services to be covered by such fee. A monthly statement for each such advance deposit shall be rendered.

(d) The unearned portion of any advance deposit made pursuant to paragraph (b) or (c) of this section shall be refunded to the depositor upon his application.

(e) All advance deposits required by the regulations in this part 429 shall be paid by money order, bank draft, or certified check drawn to the order of the Food and Drug Administration, collectible at par at Washington, DC. All deposits shall be forwarded to the Food and Drug Administration, Department of Health and Human Services, Washington, DC 20204, whereupon after making appropriate record thereof they will be transmitted to the Chief Disbursing Officer, Division of Disbursement, Treasurer of the United

Subpart F-Administrative

Procedures

8 429.50 Hearing procedure.

Hearings pursuant to $429.47 shall be governed by part 16 of this chapter.

(41 FR 48267, Nov. 2, 1976, as amended at 42 FR 15674, Mar. 22, 1977)

8 429.55 Fees.

(a)(1) Fees for the services rendered under the regulations in this part shall be such as are necessary to provide, equip, and maintain an adequate certification service.

(2) Whenever in the judgment of the Commissioner the ratio between fees collected (which are based upon experience and the best estimate of costs and the best estimate of earnings) and the costs of providing the service during an elapsed period of time, in the light of

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8 429.60 Records of distribution.

(a) The person to whom a certificate is issued shall keep complete records showing each shipment and other delivery (including exports) of each batch or part thereof, by the person requesting certification, and showing each such shipment and delivery into, or from any place in, any State or Territory, made by any person subject to his control, including records showing the date and quantity of each such shipment and delivery and the name and post office address of the person to whom such shipment or delivery was made.

(b) Upon the request of any officer or employee of the Food and Drug Administration or of any other officer or employee of the United States, acting on behalf of the Secretary, the person to whom a certificate is issued, at all reasonable hours within 2 years after disposal of all the batch covered by such certificate, shall make such records available to any such officer or employee, and shall accord to such officer or employee full opportunity to make inventory of stocks of such batch on hand and otherwise to check the correctness of such records.

§ 430.3 Definitions applicable to all

certifiable antibiotic drugs. (a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act shall be applicable to such terms when used in the regulations in this chapter covering the certification of antibiotic and antibiotic-containing drugs.

(b) The term Commissioner means the Commissioner of Food and Drugs and any other officer of the Food and Drug Administration whom he may designate to act in his behalf for the purpose of the regulations for the certification of antibiotic and antibiotic-containing drugs.

(c) The term act means the Federal Food, Drug, and Cosmetic Act and amendments thereto. (52 Stat. 1040 et seq.; 21 U.S.C. 301-392).

(d) The term U.S.P. means the official Pharmacopeia of the United States, including supplements thereto. The term N.F. means the official National Formulary, including supplements thereto.

(e) The term batch means a specific homogeneous quantity of a drug.

(f) The term batch mark means an identifying mark or other identifying device assigned to a batch by the manufacturer or packer thereof.

(g) The term manufacture does not include the use of a drug as an ingredient in compounding any prescription issued by a practitioner licensed by law to administer such drug.

PART 430-ANTIBIOTIC DRUGS;

GENERAL

Subpart A-General Provisions

[39 FR 18925, May 30, 1974)

$430.4 Definitions of antibiotic sub

stances.

Sec. 430.3 Definitions applicable to all certifiable

antibiotic drugs. 430.4 Definitions of antibiotic substances. 430.5 Definitions of master and working

standards. 430.6 Definitions of the terms "unit" and

"microgram" as applied to antibiotic substances.

(a) The following are definitions of antibiotic substances:

(1) Penicillin. Each of the several antibiotic substances (e.g., penicillin F, penicillin G, penicillin X) produced by the growth of Penicillium notatum or Penicillium chrysogenum, and each of the same substances produced by any other means, is a kind of penicillin.

(2) Streptomycin. Each of the several antibiotic substances produced by the growth of Streptomyces griseus, and each of the same substances produced by any other means, is a kind of streptomycin.

(3) Dihydrostreptomycin. Each of the antibiotic substances produced by hydrogenation of streptomycin, and each of the same substances produced by any other means, is a kind of dihydrostreptomycin.

(4) Chlortetracycline. Each of the several antibiotic substances produced by the growth of Streptomyces aureofaciens, and each of the same substances produced by any other means is a kind of chlortetracycline.

(5) Tetracycline. Each of the several antibiotic substances produced by the hydrogenation of chlortetracycline, and each of the same substances produced by any other means, is a kind of tetracycline.

(6) Chloramphenicol. Each of the several antibiotic substances produced by the growth of Streptomyces venezuelae, and each of the same substances produced by any other means, is a kind of chloramphenicol.

(7) Bacitracin. Each of the several antibiotic substances produced by the growth of Bacillus subtilis var. Tracy, and each of the same substances produced by any other means, is a kind of bacitracin.

(8) (Reserved]

(9) Amphotericin. Each of the antibiotic substances produced by the growth of Streptomyces nodosus, and each of the same substances produced by any other means, is a kind of amphortericin.

(10) Colistin. Each of the antibiotic substances produced by the growth of Bacillus polymyxa var. colistinus, and each of the same substances produced by any other means, is a kind of colistin.

(11) Cycloserine. Each of the antibiotic substances produced by the growth of Streptomyces orchidaceus, and each of the same substances produced by any other means, is a kind of cycloserine.

(12) Erythromycin. Each of the antibiotic substances produced by the

growth of Streptomyces erythreus, and each of the same substances produced by any other means, is a kind of erythromycin.

(13) Gramicidin. Each of the antibiotic substances produced by the growth of Bacillus brevis, and each of the same substances produced by any other means, is a kind of gramicidin.

(14) Griseofulvin. Each of the antibiotic substances produced by the growth of Penicillium patulum or Penicillium griseofulvum, and each of the same substances produced by any other means, is a kind of griseofulvin.

(15) Kanamycin. Each of the antibiotic substances produced by the growth of Streptomyces kanamyceticus, and each of the same substances produced by any other means, is a kind of kanamycin.

(16) Neomycin. Each of the antibiotic substances produced by the growth of Streptomyces fradiae, and each of the same substances produced by any other means, is a kind of neomycin.

(17) Novobiocin. Each of the antibiotic substances produced by the growth of Streptomyces niveus (known also as Streptomyces spheroides), and each of the same substances produced by any other means, is a kind of novobiocin.

(18) Nystatin. Each of the antibiotic substances produced by the growth of Streptomyces noursei, and each of the same substances produced by any other means, is a kind of nystatin.

(19) Oleandomycin. Each of the antibiotic substances produced by the growth of Streptomyces antibioticus, and each of the same substances produced by any other means, is a kind of oleandomycin.

(20) Trcleandomycin. Each of the antibiotic substances produced by the triacetylation of oleandomycin, and each of the same substances produced by any other means, is a kind of troleandomycin.

(21) Oxytetracycline. Each of the antibiotic substances produced by the growth of Streptomyces rimosus, and each of the same substances produced by any other means, is a kind of oxytetracycline.

(22) Paromomycin. Each of the antibiotic substances produced by the growth of Streptomyces rimosus var. paromomycinus, and each of the same

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substances produced by any other means, is a kind of paromomycin.

(23) Polymyxin. Each of the antibiotic substances produced by the growth of Bacillus polymyra, and each of the same substances produced by any other means, is a kind of polymyxin.

(24) Plicamycin. Each of the antibiotic substances produced by the growth of a variant of Streptomyces plicatus, and each of the same substances produced by any other means, is a kind of plicamycin.

(25) Tyrothricin. Each of the mixtures of antibiotic substances produced by the growth of Bacillus brevis, and each of the same mixtures of substances produced by any other means, is a kind of tyrothricin.

(26) Vancomycin. Each of the antibiotic substances produced by the growth of Streptomyces orientalis, and each of the same substances produced by any other means, is a kind of vancomycin.

(27) (Reserved]

(28) Gentamicin. Each of the antibiotic substances produced by the growth of Micromonospora purpurea, and each of the same substances produced by any other means, is a kind of gentamicin.

(29) Dactinomycin. Dactinomycin is a specific kind of actinomycin produced by the growth of Streptomyces parvullus or the same antibiotic produced by any other means.

(30) Candicidin. Each of the heptaene antibiotic substances produced by the growth of Streptomyces griseus and each of the same substances produced by any other means is

kind of candicidin.

(31) Cephalosporin. Each of the antibiotic substances produced by the growth of Cephalosporium acremonium, and each of the same substances produced by any other means, is a kind of cephalosporin.

(32) Lincomycin. Each of the antibiotic substances produced by the growth of Streptomyces lincolnensis var. lincolnensis, and each of the same substances produced by any other means, is a kind of lincomycin.

(33) Demeclocycline. Each of the antibiotic substances produced by removal of the 6-methyl group from chlortetracycline, and each of the same sub

stances produced by any other means, is a kind of demeclocycline.

(34) Clindamycin. Each of the antibiotic substances produced by the 7chloro-substitution of the 7(R)hydroxyl group of lincomycin, and each of the same substances produced by any other means, is a kind of clindamycin.

(35) [Reserved]

(36) Capreomycin. Each of the antibiotic substances produced by the growth of Streptomyces capreolus, and each of the same substances produced by any other means, is a kind of capreomycin.

(37) Rifamycin. Each of the several antibiotic substances (e.g., rifamycin A, rifamycin B, rifamycin SV) produced by the growth of

Streptomyces mediterranei, and each of the same substances produced by any other means, is a kind of rifamycin.

(38) Spectinomycin. Each of the antibiotic substances produced by the growth of Streptomyces spectabilis, and each of the same substances produced by any other means, is a kind of spectinomycin.

(39) Mitomycin. Mitomycin is the antibiotic substance produced by the growth of Streptomyces caespitosus, and each of the same substances produced by any other means is a kind of mitomycin.

(40) Doxorubicin. Each of the antibiotic substances produced by the growth of Streptomyces peucetius var. caesius, and each of the same substances produced by any other means, is a kind of doxorubicin.

(41) Bleomycin. Each of the antibiotic substances produced by the growth of Streptomyces verticillus and each of the same substances produced by any other means is a kind of bleomycin.

(42) Tobramycin. A specific one of the antibiotic substances produced by the growth of Streptomyces tenebrarius, and the same substance produced by any other means, is tobramycin.

(43) Amikacin. Each of the antibiotic substances produced by the acylation of the l-amino group of the 2-deoxystreptamine moiety of kanamycin A with L-(-)-amino-a-hydroxybuyric acid, and each of the same substances produced by any other means is a kind of amikacin.

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