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who introduces such shipment or delivery into interstate commerce holds a permit from the Commissioner authorizing shipment for repacking in such establishment.

(b) An application for such a permit shall be in a form specified by the Commissioner, and shall give the name and location of the establishment in which such repacking is to be done. Such application shall be accompanied by:

(1) A written agreement signed by the applicant that he will keep complete records showing the date, quantity, and batch mark of each shipment and other delivery of any such drug to such establishment, and that he will make such records available to any officer or employee of the Food and Drug Administration at any reasonable hour within 3 years after the date of each shipment or delivery;

(2) A written statement signed by the operator of such establishment showing that he has adequate facilities for such repacking; such statement shall contain an agreement that he will keep complete records showing the date of receipt by him and the quantity and batch mark of each such shipment and delivery and the disposition thereof, that he will make such records available to any officer or employee of the Food and Drug Administration at any reasonable hour within 3 years after the date of such disposition, and that he will accord full opportunity to such officer or employee to make inventories of stocks on hand and otherwise check the correctness of such records; and

(3) A written agreement signed by the person who will own the drug after the repacking is completed that he will request certification of each batch thereof unless it is exempt under section 801(d) of the act or $433.12, $ 433.13, $ 433.14, or $433.17, and that he will not remove any of such drug from such establishment unless it complies with section 502(1) of the act or the certification requirements of section 512(n) of the act or is so exempt or is returned to him for labeling or, if certification is refused, unless it is returned within a reasonable time to permit reprocessing and certification, destruction, or such exemption at the establishment where it was manufactured.

When the Commissioner finds that such application contains any untrue statement of a material fact or that any provision of any such agreement has been violated he may revoke such permit. Any person who contests the denial or revocation of a permit shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.

(c) An exemption of a shipment or other delivery under paragraph (a) of this section, in case the person who introduced such shipment or delivery into interstate commerce is the operator of such establishment, shall become void at the beginning of the act of removing or offering to remove such shipment or delivery or any part thereof, before or after repacking, from such establishment unless such batch complies with section 502(1) of the act or the certification requirements of section 512(n) of the act or is exempt under section 801(d) of the act or $ 433.12, $433.13, $433.14, or $433.17, or is returned to such person for labeling or, if certification is refused, unless such shipment or delivery is returned within a reasonable time to permit reprocessing and certification, destruction, or such exemption at the establishment where it was manufactured.

(d) An exemption of a shipment or other delivery under paragraph (a) of this section, in case the person who introduced such shipment or delivery into interstate commerce is not the operator of such establishment, shall expire at the beginning of the act of removing or offering to remove such shipment or delivery or any part thereof, before or after repacking, from such establishment unless such batch complies with section 502(1) of the act or the certification requirements of section 512(n) of the act or is exempt under section 801(d) of the act or $ 433.12, $433.13, $ 433.14, or $433.17, or is returned to such person for labeling or, if certification is refused, unless such shipment or delivery within a reasonable time, is destroyed or returned to permit reprocessing and certification, destruction, or such exemption at the establishment where it was manufactured.

(39 FR 18939, May 30, 1974, as amended at 41 FR 48268, Nov. 2, 1976; 42 FR 15675, Mar. 22, 1977)

8 433.17 Exemption for investigational

use.

A shipment or other delivery of an antibiotic drug shall be exempt from section 502(1) of the act or the certification requirements of section 512(n) of the act if all the procedures outlined in part 312 or $511.1 of this chapter are complied with. For the purposes of this section, the references in part 312 or $511.1 of this chapter to "new drug" and “approved new animal drug application" shall be deemed to read "antibiotic drug" and "approval for certification

exemption from certification" respectively.

or

8 433.21 Antibiotics for diagnostic use.

Antibiotics packaged for the withdrawal of individually weighed portions and intended for use solely in laboratory procedures in connection with the diagnosis or treatment of disease and conspicuously so labeled shall be exempt from the certification requirements of section 502(1) and 507 of the act and the certification requirements of section 512(n) of the act if they comply with all the following conditions:

(a) The potency, moisture content, and identity comply with the standards prescribed for the antibiotic by the specific regulations issued in this chapter.

(b) It is packaged in immediate containers that are tight containers as defined by the U.S.P. Each such container shall contain not more than 1 gram.

(C) Each package bears on the label or labeling of its outside wrapper or container and the immediate container the following:

(1) The statements “For the withdrawal of individual portions of antibiotic. Each portion must be weighed before use. Diagnostic reagent. For professional use only."

(2) The number of milligrams or grams contained in each immediate container and the potency per milligram,

(3) The batch mark. (4) The statement “Expiration date

-", the blank being filled in with the date that does not exceed the expiration date authorized for the antibiotic by this chapter.

(d) The circular or other labeling within or attached to the package bears directions adequate for the use of such drug.

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CROSS REFERENCES: For tests and methods of assay and certification of antibiotics susceptibility discs for laboratory diagnosis of disease, see 88 460.1 and 460.6 of this chapter.

(b) Packaged in a container bearing on its label or labeling the following:

(1) On the outside wrapper or container and the immediate container:

(1) The batch mark.

(11) The potency of each disc in the batch.

(iii) The expiration date as prescribed under $432.5(a)(3) of this chapter.

(iv) The statement: Not for Susceptibility Testing.

(2) On the labeling within or attached to the package: Adequate directions for use.

§ 433.22 Biologic drugs that contain

antibiotics as a preservative. Biological drugs that contain any certifiable antibiotic drug subject to the regulations in this chapter, and the purpose of the antibiotic is for use only as a preservative and the biological drug is conspicuously so labeled, shall be exempt from the requirements of sections 502(1) and 507 of the act and

the certification requirements of section 512(n) of the act, if such drugs are licensed under the Public Health Service Act of July 1, 1944 (58 Stat. 682; 42 U.S.C. 201 et seq.) or under the VirusSerum-Toxin Act of March 4, 1913 (37 Stat. 832; 21 U.S.C. 151 et seq.).

8 433.23 Microbiological culture media

containing antibiotics. Microbiological culture media that contain any certifiable antibiotic drug subject to the regulations in this chapter shall be exempt from the requirements of sections 502(1) and 507 of the act and the certification requirements of section 512(n) of the act if:

(a) They are intended for use in tissue culture and the antibiotic drug is added solely for use as an aid in the prevention of microbial contamination; or

(b) They are intended for use in the isolation of selected organisms from mixed cultures and the antibiotic drug is added solely for use as an aid in such isolation; and

(c) The certifiable antibiotic drug used in such culture media complies with the applicable standards of identity, strength, quality, and purity prescribed therefor.

packaged for use as an allergen for skin patch testing of hypersensitivity shall be exempt from the certification requirements of section 502(1) and 507 of the act if it complies with all the following conditions:

(a) It contains neomycin sulfate equivalent to 200 milligrams of neomycin per gram in petrolatum.

(b) The neomycin sulfate used in preparing the neomycin sulfate ointment conforms to the standards prescribed by $ 444.42(a)(1) of this chapter except $444,42(a)(1)(ii).

(c) The shipment of neomycin sulfate is made as a result of a specific request made to the manufacturer or distributor by a practitioner licensed by law to administer such drug, and the use of neomycin sulfate ointment for patch testing is not promoted by the manufacturer or distributor.

(d) Each package shall bear on its outside wrapper or container and on the immediate container, in addition to other labeling information required by the act and regulations, the following statements in lieu of adequate directions for use:

(1) The statement, “Caution: Federal law prohibits dispensing without prescription",

(2) The statement, “For use only in patch testing".

(3) The potency of the ointment.

(4) The expiration date as prescribed by $432.5(a)(3) of this chapter.

(e) The quantity shipped is limited to an amount reasonable for the purpose of patch testing in the normal course of the practice of medicine and is used solely for such patch testing.

(f) The manufacturer or distributor maintains records of all shipments for this purpose for a period of 2 years after shipment and will make them available to the Food and Drug Administration upon request.

§ 433.24 Exemption of arctibiotic drugs

for use in teaching, law enforce

ment, research, and analysis. Antibiotic drugs subject to section 507 or 512(n) of the act shall be exempt from the requirements of section 502(1) and from the certification requirements of section 512(n) of the act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use; or in law enforcement; or in research not involving clinical use; or in chemical analysis or physical testing, provided they are to be used only for such instruction, law enforcement, research, analysis, or testing, and provided further that their labels bear the statement "Not for drug use."

(43 FR 11151, Mar. 17, 1978]

Subpart D-Records and Reports

$ 433.25 (Reserved]

$ 433.26 Neomycin sulfate ointment in

tended for hypersensitivity testing. Neomycin sulfate ointment subject to sections 502(1) and 507 of the act and

$ 433.30 Records retention.

At the option of the person having control of records required to be kept by any regulation in this part 433, photostatic or other permannnt reproductions may be substituted for such records after the first 2 years of the holding period.

Subpart F-Chemical Tests for Specific

Antibiotics

PART 436-TESTS AND METHODS OF

ASSAY OF ANTIBIOTIC AND ANTIBIOTIC-CONTAINING DRUGS

Sec.

Subpart A-Definitions; Interpretations;

Requirements

436.1 Sterility requirements of items pack

aged with sterile antibiotic drugs. 436.2 Alternative assay methods.

Subpart B-Sterility Test Methods

436.20 Sterility test methods and proce

dures.

Subpart c-Biological Test Methods

436.31 Equipment and diluents for use in bi

ological testing. 436.32 Pyrogen test. 436.35 Depressor substances test.

Subpart D-Microbiological Assay

Methods

436.100 Laboratory equipment. 436.101 Solutions. 436.102 Culture media. 436.103 Test organisms. 436.104 Penicillin activity. 436.105 Microbiological agar diffusion assay. 436.106 Microbiological turbidimetric assay.

436.300 Polarimetric assay of carbenicillin

indanyl sodium. 436.301 Thin layer chromatography identity

test for carbenicillin indanyl. 436.302 Clindamycin vapor phase chroma

tography. 436.303 Clindamycin content of clindamycin

palmitate hydrochloride by vapor phase

chromatography. 436.304 Clindamycin phosphate vapor phase

chromatography. 436.305 Thin layer chromatographic identity

test for betacillin. 436.306 Lincomycin gas liquid chroma

tography. 436.307 Spectinomycin vapor phase chroma

tography 436.308 Paper chromatography identity test

for tetracyclines. 436.309 Anhydrotetracyclines and 4-epian

hydrotetracycline. 436.310 Thin layer chromatography identity

test for mitomycin. 436.311 Thin layer chromatography identity

test for amoxicillin. 436.312 Atomic absorption method for deter

mining the zinc content of zinc baci

tracin. 436.316 Determination of penicillin G con

tent. 436.317 Solubility characteristic test for

griseofulvin (ultramicrosize) tablets. 436.318 Continuous flow thin layer chroma

tography identity test. 436.319 Thin layer chromatography identity

test for bacitracin and bacitracin zinc. 436.320 Ferric chloride colorimetric assay. 436.321 Griseofulvin

gas liquid

chromatography. 436.322 High-pressure

liquid chromatographic assay for anthracycline

antibiotics. 436.323 Continuous flow thin layer chroma

tography identity test for cefamandole

nafate. 436.324 Polarographic analysis of

cefamandole. 436.325 High pressure liquid chroma

tography assay for vidarabine. 436.326 Thin layer chromatographic identity

test for cefoxitin sodium. 436.327 Thin layer chromatographic identity

test for cyclacillin. 436.328 High

pressure

liquid chromatographic assay for sulfisoxazole

acetyl content. 436.329 High-pressure

liquid chromatographic assay for meclocycline. 436.330 Thin layer chromatographic identity

test for bacampicillin. 436.331 High-pressure

liquid chromatographic

assay

for dactinomycin. 436.332 High-pressure

liquid

Subpart E-General Chemical Tests for

Antibiotics

436.200 Loss on drying. 436.201 Moisture determination. 436.202 PH. 436.203 Crystallinity. 436.204 Iodometric assay. 436.205 Hydroxylamine colorimetric assay. 436.206 Test for metal particles in ophthal

mic ointments. 436.207 Residue on ignition. 436.208 Heavy metals determination. 436.209 Melting range or temperature. 436.210 Specific rotation. 436.211 Identity test by

infrared spectrophotometry. 436.212 Disintegration test. 436.213 Nonaqueous titrations. 436.214 Heat stability. 436.215 Dissolution test. 436.216 High-performance

liquid chromatographic assay. 436.217 Film-coat rupture test.

free erythromycin content in erythro

mycin estolate bulk. 436.363 High-performance

liquid chromatographic assay for cefmenoxime. 436.364 Atomic absorption test for sodium

carbonate content of cefmenoxime hy

drochloride for injection. 436.365 Thin layer chromatographic identity

test for rifampin, 436.366 High-performance liquid chromatography assay

for determining chromatographic purity of vancomycin. 436.367 Thin-layer chromatographic identity

test for cephalexin hydrochloride. 436.368 Thin layer chromatographic identity

test for cefprozil. 436.369 Thin layer chromatography test for

free N-Isobutylpiperidone content in

rifabutin. 436.370 Spectrophotometric identity test for

rifabutin capsules.

Subpart G-Chemical Tests for Nonantibiotic Active Ingredients

436.400 Thin layer chromatographic identity

test for lodochlorhydroxyquin.

Subpart H-Tests for Specific Antibiotic

Dosage Forms

chromatographic assay for moxalactam. 436.333 Thin layer chromatographic identity

test for moxalactam. 436.334 High-pressure

liquid chromatographic assay for piperacillin. 436.335 High-pressure

liquid chromatographic assay

for chloramphenicol palmitate. 436.336 Thin layer chromatographic identity

test for azlocillin. 436.337 High-pressure

liquid chromatographic assay for cephradine. 436.338 High-pressure

liquid chromatographic assay for cefoperazone. 436.339 High-pressure

liquid chromatographic assay for bleomycin

fractions. 436.340 High-pressure

liquid chromatographic assay for tetracycline hydrochloride content and 4

epitetracycline hydrochloride content. 436.341 High-pressure

liquid chromatographic assay for plicamycin. 436.342 High-pressure

liquid chromatographic assay for cefazolin. 436.343 High-pressure

liquid chromatographic assay for cefuroxíme. 436.344 Thin layer chromatographic identity

test for cefuroxime. 436.345 High-pressure

liquid chromatographic assay for ceftizoxime. 436.346 High-pressure

liquid chromatographic assay for cyclosporine. 436.347 High-pressure

liquid chromatographic assay for cefoxitin. 436.348 High-pressure

liquid chromatographic assay for ceforanide. 436.349 High-pressure

liquid chromatographic assay for L-lysine in

ceforanide for injection. 436.350 High-performance

liquid chromatographic assay for cefonicid. 436.351 High-performance

liquid chromatographic assay for amoxicillin

and clavulanic acid. 436.352 High-performance

liquid chromatographic assay for determining clavam-2-carboxylate content in

clavulanate potassium. 436.353 High-performance

liquid chromatographic assay for amdinocillin. 436.354 High-performance

liquid chromatographic assay for ceftriaxone. 436.355 High-performance

liquid chromatographic assay for ticarcillin

clavulanic acid. 436.356 High-performance

liquid chromatographic assay for ceftazidime. 436.357 Atomic absorption test for sodium

carbonate content. 436.358 High-performance

liquid chromatographic assay for pyridine. 436.360 Gel permeation chromatographic

assay for high molecular weight polymer. 436.361 High-performance

liquid chromatographic assay for aztreonam. 436.362 Thin-layer chromatographic test for

436.500 Penicillin in oil and wax. 436.503 Procaine penicillin and buffered

crystalline penicillin for aqueous injec

tion. 436.504 Penicillin-bacitracin ointment. 436.505 Penicillin-streptomycin-bacitracin

ointment; penicillin-dihydrostreptomycin-bacitracin ointment; penicillinstreptomycin-bacitracin methylene disalicylate ointment; penicillin-dihydrostreptomycin-bacitracin methylene disa

licylate ointment. 436.506 Benzathine penicillin G and buffered

crystalline penicillin for aqueous injec

tion. 436.507 Benzathine-procaine-buffered crys

talline penicillins for aqueous injection. 436.508 Penicillin bacitracin neomycin

ointment; penicillin-bacitracin-neomycin

in oil. 436.509 Procaine

penicillin-streptomycinpolymyxin in oil; procaine penicillin-dihydrostreptomycin-polymyxin in oil; procaine penicillin-streptomycin-polymyxin ointment; procaine penicillin-di

hydrostreptomycin-polymyxin ointment. 436.510 Penicillin streptomycin erythro

mycin ointment; penicillin-dihydro

streptomycin - erythromycin ointment. 436.511 Penicillin-streptomycin-bacitracin

methylene disalicylate-neomycin ointment; penicillin-dihydrostreptomycinbacitracin methylene disalicylate-neo

mycin ointment. 436.512 Procaine penicillin G-novobiocin-ne

omycin-dihydrostreptomycin in oil.

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