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355 Subpart D—Records and Reports PART 436—TESTS AND Food and Drug Administration, HHS Pt. 436 from the requirements of section 502(l) (e) The quantity shipped is limited to and from the certification require- an amount reasonable for the purpose ments of section 512(n) of the act if of patch testing in the normal course shipped or sold to, or in the possession of the practice of medicine and is used of, persons regularly and lawfully en- solely for such patch testing. gaged in instruction in pharmacy, (f) The manufacturer or distributor chemistry, or medicine not involving maintains records of all shipments for clinical use; or in law enforcement; or this purpose for a period of 2 years in research not involving clinical use; after shipment and will make them or in chemical analysis or physical available to the Food and Drug Admin- testing, provided they are to be used istration upon request. only for such instruction, law enforce- ment, research, analysis, or testing, [43 FR 11151, Mar. 17, 1978] and provided further that their labels bear the statement ``Not for drug use.'' Subpart DÐRecords and Reports § 433.25 [Reserved] § 433.30 Records retention. § 433.26 Neomycin sulfate ointment in- At the option of the person having tended for hypersensitivity testing. control of records required to be kept Neomycin sulfate ointment subject by any regulation in this part 433, pho- to sections 502(l) and 507 of the act and tostatic or other permannnt reproduc- packaged for use as an allergen for skin tions may be substituted for such patch testing of hypersensitivity shall records after the first 2 years of the be exempt from the certification re- holding period. quirements of section 502(l) and 507 of the act if it complies with all the fol- PART 436ÐTESTS AND METHODS OF lowing conditions: ASSAY OF ANTIBIOTIC AND AN- (a) It contains neomycin sulfate TIBIOTIC-CONTAINING DRUGS equivalent to 200 milligrams of neomy- cin per gram in petrolatum. Sec. (b) The neomycin sulfate used in pre- paring the neomycin sulfate ointment Subpart AÐDefinitions; Interpretations; conforms to the standards prescribed Requirements by § 444.42(a)(1) of this chapter except § 444.42(a)(1)(ii). 436.1 Sterility requirements of items (c) The shipment of neomycin sulfate packaged with sterile antibiotic drugs. is made as a result of a specific request 436.2 Alternative assay methods. made to the manufacturer or distribu- tor by a practitioner licensed by law to Subpart BÐSterility Test Methods administer such drug, and the use of 436.20 Sterility test methods and proce- neomycin sulfate ointment for patch dures. testing is not promoted by the manu- facturer or distributor. Subpart CÐBiological Test Methods (d) Each package shall bear on its outside wrapper or container and on 436.31 Equipment and diluents for use in bi- the immediate container, in addition ological testing. to other labeling information required 436.32 Pyrogen test. by the act and regulations, the follow- 436.35 Depressor substances test. ing statements in lieu of adequate di- rections for use: Subpart DÐMicrobiological Assay (1) The statement, ``Caution: Federal Methods law prohibits dispensing without pre- 436.100 Laboratory equipment. scription''. 436.101 Solutions. (2) The statement, ``For use only in 436.102 Culture media. patch testing''. 436.103 Test organisms. (3) The potency of the ointment. 436.104 Penicillin activity. (4) The expiration date as prescribed 436.105 Microbiological agar diffusion assay. by § 432.5(a)(3) of this chapter. 436.106 Microbiological turbidimetric assay. 355 VerDate 29<MAY>97 12:37 Jun 06, 1997 Jkt 174063 PO 00000 Frm 00350 Fmt 8010 Sfmt 8010 21V5.TXT pfrm13 Pt. 436 21 CFR Ch. I (4±1±97 Edition) Subpart EÐGeneral Chemical Tests for 436.322 High±pressure liquid Antibiotics chromatographic assay for anthracycline antibiotics. 436.200 Loss on drying. 436.323 Continuous flow thin layer chroma- 436.201 Moisture determination. tography identity test for cefamandole 436.202 pH. nafate. 436.203 Crystallinity. 436.324 Polarographic analysis of 436.204 Iodometric assay. cefamandole. 436.205 Hydroxylamine colorimetric assay. 436.325 High pressure liquid chroma- 436.206 Test for metal particles in ophthal- tography assay for vidarabine. mic ointments. 436.326 Thin layer chromatographic identity 436.207 Residue on ignition. test for cefoxitin sodium. 436.208 Heavy metals determination. 436.327 Thin layer chromatographic identity 436.209 Melting range or temperature. test for cyclacillin. 436.210 Specific rotation. 436.328 High pressure liquid 436.211 Identity tests by infrared chromatographic assay for sulfisoxazole spectrophotometry. acetyl content. 436.212 Disintegration test. 436.329 High-pressure liquid 436.213 Nonaqueous titrations. chromatographic assay for meclocycline. 436.214 Heat stability. 436.330 Thin layer chromatographic identity 436.215 Dissolution test. test for bacampicillin. 436.216 High±performance liquid 436.331 High-pressure liquid chromatographic assay. chromatographic assay for 436.217 Film-coat rupture test. dactinomycin. 436.332 High-pressure liquid Subpart FÐChemical Tests for Specific chromatographic assay for moxalactam. Antibiotics 436.333 Thin layer chromatographic identity test for moxalactam. 436.300 Polarimetric assay of carbenicillin 436.334 High-pressure liquid indanyl sodium. chromatographic assay for piperacillin. 436.301 Thin layer chromatography identity 436.335 High-pressure liquid test for carbenicillin indanyl. chromatographic assay for chlor- 436.302 Clindamycin vapor phase chroma- amphenicol palmitate. tography. 436.336 Thin layer chromatographic identity 436.303 Clindamycin content of clindamycin test for azlocillin. palmitate hydrochloride by vapor phase 436.337 High-pressure liquid chromatography. chromatographic assay for cephradine. 436.304 Clindamycin phosphate vapor phase 436.338 High-pressure liquid chromatography. chromatographic assay for cefoperazone. 436.305 Thin layer chromatographic identity 436.339 High-pressure liquid test for hetacillin. chromatographic assay for bleomycin 436.306 Lincomycin gas liquid chroma- fractions. tography. 436.340 High-pressure liquid 436.307 Spectinomycin vapor phase chroma- chromatographic assay for tetracycline tography. hydrochloride content and 4± 436.308 Paper chromatography identity test epitetracycline hydrochloride content. for tetracyclines. 436.341 High-pressure liquid 436.309 Anhydrotetracyclines and 4-epian- chromatographic assay for plicamycin. hydrotetracycline. 436.342 High-pressure liquid 436.310 Thin layer chromatography identity chromatographic assay for cefazolin. test for mitomycin. 436.343 High-pressure liquid 436.311 Thin layer chromatography identity chromatographic assay for cefuroxime. test for amoxicillin. 436.344 Thin layer chromatographic identity 436.312 Atomic absorption method for deter- test for cefuroxime. mining the zinc content of zinc baci- 436.345 High-pressure liquid tracin. chromatographic assay for ceftizoxime. 436.316 Determination of penicillin G con- 436.346 High-pressure liquid tent. chromatographic assay for cyclosporine. 436.317 Solubility characteristic test for 436.347 High-pressure liquid griseofulvin (ultramicrosize) tablets. chromatographic assay for cefoxitin. 436.318 Continuous flow thin layer chroma- 436.348 High-pressure liquid tography identity test. chromatographic assay for ceforanide. 436.319 Thin layer chromatography identity 436.349 High-pressure liquid test for bacitracin and bacitracin zinc. chromatographic assay for L-lysine in 436.320 Ferric chloride colorimetric assay. ceforanide for injection. 436.321 Griseofulvin gas liquid chroma- 436.350 High-performance liquid tography. chromatographic assay for cefonicid. 356 VerDate 29<MAY>97 12:37 Jun 06, 1997 Jkt 174063 PO 00000 Frm 00351 Fmt 8010 Sfmt 8010 21V5.TXT pfrm13 Food and Drug Administration, HHS Pt. 436 436.351 High-performance liquid 436.505 Penicillin-streptomycin-bacitracin chromatographic assay for amoxicillin ointment; penicillin-dihydrostrepto- and clavulanic acid. mycin-bacitracin ointment; penicillin- 436.352 High-performance liquid streptomycin-bacitracin methylene disa- chromatographic assay for determining licylate ointment; penicillin-dihydro- clavam-2-carboxylate content in streptomycin-bacitracin methylene disa- clavulanate potassium. licylate ointment. 436.353 High-performance liquid 436.506 Benzathine penicillin G and buffered chromatographic assay for amdinocillin. crystalline penicillin for aqueous injec- 436.354 High-performance liquid tion. chromatographic assay for ceftriaxone. 436.507 Benzathine-procaine-buffered crys- 436.355 High±performance liquid talline penicillins for aqueous injection. chromatographic assay for ticarcillin± 436.508 Penicillin - bacitracin - neomycin clavulanic acid. ointment; penicillin-bacitracin-neomycin 436.356 High±performance liquid in oil. chromatographic assay for ceftazidime. 436.509 Procaine penicillin-streptomycin- 436.357 Atomic absorption test for sodium polymyxin in oil; procaine penicillin-di- carbonate content. hydrostreptomycin-polymyxin in oil; 436.358 High±performance liquid procaine penicillin-streptomycin- chromatographic assay for pyridine. polymyxin ointment; procaine penicillin- dihydrostreptomycin-polymyxin oint- 436.360 Gel permeation chromatographic ment. assay for high molecular weight polymer. 436.510 Penicillin - streptomycin - erythro- 436.361 High±performance liquid mycin ointment; penicillin-dihydro- chromatographic assay for aztreonam. streptomycin - erythromycin ointment. 436.362 Thin-layer chromatographic test for 436.511 Penicillin-streptomycin-bacitracin
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