§ 430.4 - Definitions of 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) Troleandomycin. 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 substances produced by any other means, is a kind of paromomycin.

(23) Polymyxin. Each of the antibiotic substances produced by the growth of Bacillus polymyxa, 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 a 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 substances produced by any other means, is a kind of demeclocycline.

(34) Clindamycin. Each of the antibiotic substances produced by the 7-chloro-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 1-amino group of the 2-deoxy-streptamine moiety of kanamycin A with L-(-)-γ)amino-α-hydroxybuyric acid, and each of the same substances produced by any other means is a kind of amikacin.

(44) Vidarabine. Vidarabine is a purine glycoside antibiotic substance produced by the growth of Streptomyces antibioticus, and each of the same substances produced by any other means is a kind of vidarabine.

(45) Natamycin. Each of the antibiotic substances produced by the growth of Streptomyces natalensis, and each of the same substances produced by any other means, is a kind of natamycin.

(46) Daunorubicin. Each of the antibiotic substances produced by the growth of Streptomyces coeruleorubidus and each of the same substances produced by any other means is a kind of daunorubicin.

(47) Sisomicin. A specific one of the antibiotic substances produced by the growth of Micromonospora inyoensis, and the same substance produced by any other means, is a kind of sisomicin.

(48) Moxalactam. 5-oxa-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[carboxy(4-hydroxyphenyl)acetyl]-amino]-7-methoxy-3-[[(1-methyl-1H-tetrazol-5-yl)thio]-methyl]-8-oxo-, disodium salt.

(49) Cefoperazone. Cefoperazone is a semi-synthetic antibiotic substance produced by the acylation of the amino group at the 7 position of 7-aminocephalosporanic acid with α-(4-ethyl-2,3-dioxo-1-piperazinecarboxamido)-α-(4-hydroxyphenyl) acetic acid and introduction of a methylthiotetrazol group at the 3 position.

(50) Netilmicin. Netilmicin is a semi-synthetic antibiotic of the aminoglycoside group derived from sisomicin, and each of the same substances produced by any other means is a kind of netilmicin. It is d-Streptamine, 4-O-[3-amino-6-(aminomethyl)-3,4-dihydro-2H-pyran-2-yl]-2-deoxy-6-O-[3-deoxy-4-C-methyl-3-(methylamino)-β-l-arabinopyranosyl]-N1-ethyl-, (2S-cis)-.

(51) Cyclosporine. Cyclosporine is a specific cyclic polypeptide consisting of 11 amino acids produced by the growth of Cylindrocarpon lucidum Booth or Tolypocladium inflatum Gams.

(52) Cefonicid. 5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[(hydroxyphenylacetyl)amino]-8-oxo-3[[[1-(sulfomethyl)-1H-tetrazol-5yl]-thio]methyl]-, disodium salt, [6R-[6α7β(R*)]].

(53) Clavulanic acid. Clavulanic acid is an antibiotic substance produced by the growth of Streptomyces clavuligerus having the structure described as follows: Z-(2R, 5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, and each of the same substances produced by any other means, is a kind of clavulanic acid.

(54) Ceftriaxone. Ceftriaxone is a semi-synthetic antibiotic substance produced by the addition of S-2-benzothiazolyl-2-(2-aminothiazol-4-yl)-2-methoxyiminothioacetate to the 7 amino group of 7-amino-3-(2,5-dihydro-2 methyl-5,6-dioxo-1,2,4-triazin-3-yl)-thiomethyl-3-cephem-4-carboxylic acid.

(55) Imipenem monohydrate. Imipenem monohydrate is an antibiotic substance having the chemical structure described by the following name: [5R-[5α,6α,(R*)]]-6-(1-hydroxyethyl)-3-[[2-[(iminomethyl)amino]ethyl]thio]-7-oxo-1-azabicyclo[3.2.0]-hept-2-ene-2-carboxylic acid monohydrate.

(56) Aztreonam. [2S[2alpha,3beta(Z)]]-2-[[[1-(2-amino-4-thiazolyl)-2-[(2-methyl-4-oxo-1-sulfo-3-azetidinyl)amino]-2-oxoethylidene]amino]oxy]-2-methylpropanoic acid.

(57) Sulbactam. Sulbactam is a semi-synthetic antibiotic substance produced by the oxidation of the sulfur atom at the 4 position to its dioxide and the deamination at the 6 position of (2S,5R)-6-amino-3,3-dimethyl-7-oxo-4 thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid (6-APA).

(58) Cefmenoxime. Cefmenoxime is 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[(2-amino-4-thiazolyl) (methoxyimino)acetyl]amino]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-, [6R-[6-α,7-β(Z)]]-.

(59) Cefixime. Cefixime is a semisynthetic antibiotic substance produced by the acylation of the amino group at the 7 position of 7-aminocephalosporanic acid with a β-[(2-amino-4-thiazolyl) (carboxymethoxy)imino] acetyl group and the introduction of a vinyl group at the 3 position.

(60) Cefotiam. Cefotiam is an antibiotic substance having the chemical structure described by the following name: 7-(R)-[2-(2-amino-4-thiazol)acetamido]-3-[[[1-(2-dimethylamino)ethyl]-1H-tetrazol-5-y1] thio] methyl]-3-cephem-4-carboxylic acid.

(61) Mupirocin. Each of the antibiotic substances produced by the growth of Pseudomonas fluorescens, and each of the same substances produced by any other means, is a kind of mupirocin.

(62) Cefmetazole. Cefmetazole is an antibiotic substance having the chemical structure described by the following name: (6R-cis)-7- [[[cyanomethyl)thio]acetyl]amino]-7- methoxy-3-[[(1-methyl-1H- tetrazol-5-yl)thio]methyl]-8-oxo-5- thia-1-azabicyclo[4.2.0]oct-2- ene-2-carboxylic acid.

(63) Cefpiramide. Cefpiramide is an antibiotic substance having the chemical structure described by the following name: (6R, 7R)-7-[(R)-2-(4-hydroxy-6- methyl-nicotinamido)-2-(p- hydroxyphenyl)acetamido]-3-[[(1- methyl-1H-tetrazol-5-yl)thio]methyl]-8- oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene- 2-carboxylic acid.

(64) Clarithromycin. Clarithromycin is 6-O-methylerythromycin A.

(65) Azithromycin. Azithromycin is an antibiotic substance having the chemical structure described by the following name: (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one.

(66) Cefprozil. Cefprozil is an antibiotic substance having the chemical structure described by the following name: (6R,7R)-7-[(R)-2-amino-2-(p-hydroxyphenyl)acetamido]8-oxo-3-propenyl-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. It is a mixture of the Z (cis) and E (trans) isomers in an approximate ratio of 9:1, respectively.

(67) Idarubicin. Idarubicin is an anthracycline antibiotic substance having the chemical structure described by the following name: 5,12-Naphthacenedione, 9-acetyl-7-[(3-amino-2,3,6-trideoxy-α-L-lyxo- hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,9,11-trihydroxy-(7S-cis).

(68) Loracarbef. Loracarbef is an antibiotic substance having the chemical structure described by the following name: (6R,7S)-7-[(R)-2-amino-2-phenylacetamido]-3-chloro-8-oxo-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid.

(69) Rifabutin. Rifabutin is an antibiotic substance having the chemical structure described by the following name: (9S,12E,14S,15R,16S,17R,18R,19R, 20S,21S,22E, 24Z)-6,16, 18,20-tetrahydroxy-1′-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethylspiro[9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2′,3′:7,8]naphth[1,2-d]imidazole-2,4′-piperidine]-5,10,26-(3H,9H)-trione-16-acetate.

(70) Cefpodoxime proxetil. Cefpodoxime proxetil is an antibiotic substance having the chemical structure described by the following name: (±)-1-Hydroxyethyl(+)-(6R,7R)-7-[2-(2-amino-4-thiazolyl)glyoxylamido]-3-(methoxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate,72-(Z)-(O-methyloxime), isopropyl carbonate (ester).

(b) [Reserved]