Lapas attēli
PDF
ePub

micrograms of the rifampin master standard.

(49) Minocycline. The term “microgram" applied to minocycline means the minocycline activity (potency) contained in 1.1588 micrograms of the minocycline master standard.

(50) Spectinomycin. The term "microgram" applied to spectinomycin means the spectinomycin activity (potency) contained in 1.490 micrograms of the spectinomycin master standard.

(51) Clindamycin palmitate hydrochloride. The term “microgram” applied to clindamycin palmitate hydrochloride means the clindamycin activity (potency) contained in 1.661 micrograms of the clindamycin palmitate hydrochloride master standard.

(52) Carbenicillin indanyl. The term "microgram" applied to carbenicillin indanyl means the carbenicillin activity (potency) contained in 1.4514 micrograms of the carbenicillin indanyl master standard.

(53) Cephapirin. The term “microgram" applied to cephapirin means the cephapirin activity (potency) contained in 1.0616 micrograms of the cephapirin master standard.

(54) Cefazolin. The term “microgram" applied

cefazolin means the cefazolin activity (potency) contained in 1.005 micrograms of the cefazolin master standard.

(55) Mitomycin. The term "microgram" applied to mitomycin means the mitomycin activity (potency) contained in 1.0416. micrograms of the mitomycin master standard.

(56) Amoxicillin. The term "microgram" applied to amoxicillin means the amoxicillin activity (potency) contained in 1.17647 micrograms of the amoxicillin master standard.

(57) [Reserved]

(58) Cephradine. The term "microgram" applied to cephradine means the cephradine activity (potency) contained in 1.1111 micrograms of the cephradine master standard.

(59) Doxorubicin. The term “microgram" applied to doxorubicin

the activity (potency) calculated as doxorubicin hydrochloride contained in 1.0204 micrograms of the doxorubicin master standard.

(60) Tobramycin. The term “microgram" applied to tobramycin means the tobramycin activity (potency) contained in 1.126 micrograms of the tobramycin master standard.

(61) Amikacin. The term “microgram" applied to amikacin means the amikacin activity (potency) contained in 1.091 micrograms of the amikacin master standard.

(62) Vidarabine. The term "microgram" applied to vidarabine means the vidarabine activity (potency) contained in 1.0674 micrograms of the vidarabine master standard.

(63) Ticarcillin. The term "microgram" applied to ticarcillin means the ticarcillin activity (potency) contained in 1.136 micrograms of the ticarcillin master standard.

(64) Cefadroxil. The term "microgram" applied to cefadroxil means the cefadroxil activity (potency) contained in 1.0537 micrograms of the cefadroxil master standard.

(65) Natamycin. The term "microgram" applied to natamycin means the natamycin activity (potency) contained in 1.0846 micrograms of the natamycin master standard.

(66) Cefoxitin. The term “microgram" applied to cefoxitin

the cefoxitin activity (potency) contained in 1.072 micrograms of the cefoxitin master standard.

(67) Cefamandole. The term “microgram" applied to cefamandole means the cefamandole activity (potency) contained in 1.1364 micrograms of cefamandole master standard.

(68) Cefaclor. The term "microgram" applied to cefaclor means the cefaclor activity (potency) contained in 1.0493 micrograms of cefaclor master standard.

(69) Cyclacillin. The term “microgram" applied to cyclacillin means the cyclacillin activity (potency) contained in 1.01 micrograms of the cyclacillin master standard.

(70) Daunorubicin. The term "microgram" applied to daunorubicin means the daunorubicin activity (potency) contained in 1.0965 micrograms of the daunorubicin master standard.

(71) Sisomicin. The term "microgram" applied to sisomicin means the sisomicin activity (potency) contained

means

to

means

(83) Ceforanide. The term "microgram" applied to ceforanide means

the ceforanide activity (potency) contained in 1.005 micrograms of the ceforanide master standard.

(84) Cefonicid. The term "microgram”

in 1.00 microgram of the sisomicin master standard expressed on an anhydrous basis.

(72) Meclocycline. The term "microgram" applied to meclocycline means the meclocycline activity (potency) contained in 1.0493 micrograms of the meclocycline master standard.

(73) Cefotaxime. The term "microgram" applied to cefotaxime means the cefotaxime activity (potency) contained in 1.089 micrograms of cefotaxime master standard.

(74) Mezlocillin. The term "microgram" applied to meziocillin means the mezlocillin activity (potency) contained in 1.1086 micrograms of the mezlocillin master standard.

(75) Moxalactam. The term "microgram" applied to moxalactam means the moxalactam activity (potency) contained in 1.1173 micrograms of the moxalactam master standard.

(76) Piperacillin. The term "microgram" applied to piperacillin means the piperacillin activity (potency) contained in 1.0460 micrograms of the piperacillin master standard.

(77) Cefoperazone. The term "microgram" applied to cefoperazone means the cefoperazone activity (potency) contained in 1.056 micrograms of the cefoperazone master standard.

(78) Azlocillin. The term “microgram” applied to azlocillin means the azlocillin activity (potency) contained in 1.128 micrograms of the azlocillin master standard.

(79) Netilmicin. The term “microgram" applied to netilmicin means the netilmicin activity (potency) contained in 1.000 microgram of the netilmicin master standard expressed on an anhydrous basis.

(80) Cefuroxime. The term "microgram" applied to cefuroxime means the cefuroxime activity (potency) contained in 1.0893 micrograms of the cefuroxime master standard.

(81) Ceftizozime. The term "microgram" applied to ceftizoxime means the ceftizoxime activity (potency) contained in 1.011 micrograms of the ceftizoxime master standard.

(82) Cyclosporine. The term “microgram" applied to cyclosporine means the cyclosporine activity (potency) contained in 1.0173 micrograms of cyclosporine master standard.

applied to cefonicid means the cefonicid activity (potency) contained in 1.150 micrograms of the cefonicid master standard.

(85) Clavulanic acid. The term "microgram" applied to clavulanic acid means the clavulanic acid activity (potency) contained in 1.053 micrograms of clavulanic acid master standard.

(86) Amdinocillin. The term "microgram” applied to amdinocillin means the amdinocillin activity (potency) contained in 1.004 micrograms of the amdinocillin master standard.

(87) Ceftriaxone. The term “microgram" applied to ceftriaxone means the ceftriaxone activity (potency) contained in 1.19 micrograms of the ceftriaxone master standard.

(88) Ceftazidime. The term “microgram" applied to ceftazidime means the ceftazidime activity (potency) contained in 1.1834 micrograms of the ceftazidime master standard.

(89) Imipenem. The term “microgram" applied to imipenem monohydrate means the imipenem activity (potency) contained in 1.085 micrograms of the imipenem master standard.

(90) Cefotetan. The term “microgram" applied to cefotetan means the cefotetan activity (potency) contained in 1.012 micrograms of the cefotetan master standard.

(91) Aztreonam. The term "microgram" applied to aztreonam means the aztreonam activity (potency) contained in 1.05 micrograms of the aztreonam master standard.

(92) Sulbactam. The term "microgram" applied to sulbactam means the sulbactam activity (potency) contained in 1.002 micrograms of the sulbactam master standard.

(93) Cefuroxime axetil. The term “microgram" applied to cefuroxime axetil means the cefuroxime activity (potency) contained in 1.246 micrograms of the cefuroxime axetil master standard.

(94) Cefmenorime. The term "microgram" applied to cefmenoxime

[ocr errors]

chloride contained in 1.036 micrograms of the idarubicin master standard.

(105) Loracarbef. The term "microgram" applied to loracarbef means the loracarbef (potency) contained in 1.059 micrograms of the loracarbef master standard.

(106) Rifabutin. The term "microgram" applied to rifabutin means the rifabutin (potency) contained in 1.022 micrograms of the rifabutin master standard.

(107) Cefpodorime proxetil. The term “microgram" applied to cefpodoxime proxetil means the cefpodoxime (potency) contained in 1.304 micrograms of the cefpodoxime proxetil master standard when dried.

(39 FR 18925, May 30, 1974)

means

EDITORIAL NOTE: For FEDERAL REGISTER CItations affecting $430.6, see the List of CFR Sections Affected appearing in the Finding Aids section of this volume.

Subpart B-Antibiotic Drugs Af

fected by the Drug Amendments of 1962

means the cefmenoxime activity (potency) contained in 1.0482 micrograms of the cefmenoxime master standard.

(95) Cefixime. The term “microgram” applied to cefixime means the cefixime activity (potency) contained in 1.126 micrograms of the cefixime master standard.

(96) Cefotiam. The term "microgram" applied to cefotiam means the cefotiam (potency) contained in 1.144 micrograms of the cefotiam master standard.

(97) Clindamycin phosphate. The term "microgram" applied to clindamycin phosphate means the clindamycin phosphate (potency) contained in 1.252 micrograms of the clindamycin phosphate master standard.

(98) Mupirocin. The term "microgram" applied to

to mupirocin the activity (potency) calculated as mupirocin activity (potency) contained in 1.075 micrograms of the mupirocin master standard.

(99) Cefmetazole. The term "microgram" applied to cefmetazole means the cefmetazole (potency) contained in 1.002 micrograms of the cefmetazole master standard.

(100) Cefpiramide. The term “microgram" applied to cefpiramide means the cefpiramide (potency) contained in 0.994 microgram of the cefpiramide master standard.

(101) Clarithromycin. The term "microgram"

applied

to clarithromycin

the clarithromycin (potency) contained in 1.010 micrograms of the clarithromycin master standard.

(102) Azithromycin. The term “microgram" applied to azithromycin means the azithromycin (potency) contained in 1.063 micrograms of the azithromycin master standard.

(103) Cefprozil. The term "microgram" applied to cefprozil (Z) means the cefprozil (Z) potency contained in 1.060 micrograms of the cefprozil (Z) master standard. The term “microgram" applied to cefprozil (E) means the cefprozil (E) potency contained in 1.106 micrograms of the cefprozil (E) master standard.

(104) Idarubicin. The term "microgram" applied to idarubicin

the idarubicin activity (potency) calculated as idarubicin hydro

§ 430.10 Certification or release of an

tibiotic drugs affected by the drug amendments of 1962.

means

(a) Before the 1962 amendments to it, the Federal Food, Drug, and Cosmetic Act only permitted the Food and Drug Administration to provide for the certification of batches of antibiotic drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any derivative of them. FDA certified those drugs under regulations promulgated on the basis of scientific proof of the drugs' safety and effectiveness. Most drugs containing an antibiotic other than one of those listed were subject to the new drug provisions of the act, which required that an applicant show that the drug was safe and obtain FDA approval of a new drug application before marketing it. An affirmative showing of effectiveness was not then required to obtain approval. Some antibiotic drugs that were not subject to certification, however, were also not subject to the new drug provisions of the act under informal FDA opinions that the drug was "not a new drug" or "no longer a new drug." FDA

means

termination that the drug has not been shown to be safe or lacks substantial evidence of effectiveness under the DESI program. FDA is proceeding under its DESI program to establish regulations under section 507 to provide for certification of those drugs only if they have been shown to be safe and effective.

(50 FR 7516, Feb. 22, 1985)

PART 431-CERTIFICATION OF

ANTIBIOTIC DRUGS

Subpart A-General Provisions

Sec. 431.1 Requests for certification, check tests

and assays, and working standards; infor

mation and samples required. 431.5 Samples for sterility testing. 431.10 Certification. 431.11 Conditions on the effectiveness of cer

tificates. 431.12 Certification of antibiotic drugs after

shipment in bulk containers. 431.17 Request to provide for certification of

an antibiotic drug. 431.20 Disposition of outdated drugs.

revoked those opinions under $310.100 of this chapter.

(b) The 1962 amendments amended section 507 of the act to require the certification, release without certification, or exemption from certification, of all antibiotic drugs on the basis of scientific proof of safety and effectiveness. The amendments provided that FDA implement them for antibiotic drugs that were marketed on April 30, 1963 and were not subject to the certification provisions on that date. FDA is implementing the amendments with respect to antibiotic drugs formerly subject to the new drug provisions of the act through its Drug Efficacy Study Implementation (DESI) program under which the agency is evaluating those antibiotic drugs for efficacy. Until FDA completes that evaluation it will permit continued marketing of those antibiotic drugs under paragraph (c) of this section. The agency is also implementing the 1962 amendments with respect to antibiotic drugs formerly not subject to either the certification or new drug provisions of the act and the agency is evaluating those antibiotic drugs for both safety and efficacy. Until FDA completes that evaluation, it will permit continued marketing of those antibiotic drugs under paragraph (d) of this section.

(c) Unless exempted from certification, FDA will certify or release antibiotic drugs which on April 30, 1963 were the subject of an approved new drug application under section 505 of the act, under regulations providing for certification of the drugs. Although the initial regulation for each of these drugs established under section 507(h) of the act was not conditioned upon an affirmative finding of the effectiveness of the drug, FDA is proceeding under its DESI program to amend or repeal those regulations to provide for certification of those drugs only if they had been shown to be both safe and effective.

(d) Unless exempted from certification, FDA will release without certification an antibiotic drug that was marketed on April 30, 1963, but not subject to certification, and not subject to an approved new drug application on that date, unless FDA has made a de

Subpart B-Administrative Procedures

431.50 Forms for certification or exemption

of antibiotic drugs. 431.51 Suspension of certification service. 431.52 Hearings. 431.53 Fees.

Subpart C-Records and Reports

431.61 Records of distribution, 431.62 Records retention.

Subpart D-Confidentiality of Information

431.70 Confidentiality of data and informa

tion in an investigational new drug notice for an antibiotic drug.

AUTHORITY: 21 U.S.C. 351, 352, 353, 355, 357, 379e; 42 U.S.C. 216, 241, 262; 5 U.S.C. 552.

SOURCE: 39 FR 18934, May 30, 1974, unless otherwise noted.

Subpart A-General Provisions

§ 431.1 Requests for certification,

check tests and assays, and working standards; information and samples

required. (a) A request for certification of a batch (antibiotic Form 7/Form FDA1677) is to be addressed to the Food and Drug Administration, Division of Research and Testing (HFD-470), 200 C St. SW., Washington, DC 20204.

(b) (Reserved]

(c) A person who requests certification or check tests and assays of a batch shall submit with his request the following information and samples:

(1) The batch mark of the drug.

(2) The quantity of each ingredient used in making the batch and a statement that each such ingredient conforms to the requirements or standards prescribed therefor, if any, by specific regulations or official compendium or otherwise approved by the Commissioner.

(3) The size of the batch, including the number of containers of each size in the batch.

(4) The date of the latest assay of the batch.

(5) The results of the latest tests and assays made by or for him on the batch as required for the drug by specific regulations.

(6) The batch mark(s) of the antibiotic(s) used in making the batch.

(7) Unless previously submitted, the results and dates of the latest tests and assays made by or for him on the antibiotic(s) used in making the batch as required by specific regulations.

(8) The number of accurately representative samples that are required for the batch by specific regulations:

(1) In the case of drugs such as dry powders, solutions, ointments, and suspensions, the sample shall be collected by taking single immediate containers, before or after labeling, at such intervals throughout the entire time of packaging the batch that the quantities packaged during the intervals are approximately equal. In no case, however, shall more than 5,000 immediate containers have been packaged during each such interval of sampling, except for a sample collected for sterility testing.

(ii) In the case of drugs in unit dosage forms, such as tablets, capsules, or suppositories, samples shall be collected as follows:

(a) From batches exceeding 500,000 units, a representative sample consisting of 100 units shall be collected by taking single units at approximately equal intervals throughout the final

production of the batch. If the person packaging the units into dispensingsize containers is not the manufacturer, the representative sample consisting of 100 units shall be collected by taking single units at approximately equal intervals during packaging.

(6) From batches of 500,000 units or less, a representative sample consisting of not more than 100 units shall be collected by taking single units at approximately equal intervals throughout the final production of the batch. If the person packaging the units into dispensing-size containers is not the manufacturer, the samples shall be collected by taking single units at approximately equal intervals during packaging. In no case shall more than 5,000 units be produced or packaged during a sampling interval. The minimum acceptable sample size shall be as specified in the appropriate monograph.

(c) When the manufacturing process is such that it is not feasible to collect the samples throughout the final production of the batch (e.g., if tablets undergo further processing, such as polishing or coating, after being compressed), the samples may be collected from bulk containers of the finished product, according to the following requirements:

(1) For batches exceeding 500,000 units: If the batch is in more than 100 containers, the sample is 1 unit from each container. If the batch is in 100 containers or less, the sample is 100 units, taken in approximately equal amounts from each container.

(2) For batches of 500,000 units or less: If the batch is in more than 100 containers, the sample is 1 unit from each container. If the batch is in 100 containers or less, the sample is at least 1 unit for every 5,000 units in the batch taken in approximately equal amounts from each container. The sample shall not be less than the minimum number of units specified in the appropriate monograph

(iii) In the case of drugs packaged for repacking or for use in the manufacture of another drug, the sample must be representative of the batch. Such samples may be taken from a composite composed of portions taken from a

« iepriekšējāTurpināt »