D&C RED 33 USE IN INGESTED DRUGS OKAYED BY FDA
D&C RED 33 USE IN INGESTED DRUGS OKAYED BY FDA for products other than mouthwashes and dentifrices "in amounts not to exceed .75 milligrams per daily dose of the drug." According to an Aug. 30 Federal Register notice the color can also be used "in externally applied drugs, mouthwashes, and dentifrices in amounts consistent with current good manufacturing practice." The publication date coincided with the expiration of the permanent listing of the additive. The new rule takes effect Sept. 30. In reviewing the data submitted on Red 33, the agency found that the dye "has not induced cancer in any of the laboratory testing," a finding supported by the National Toxicoloby Program's Board of Scientific Counselors. Therefore, Red 33 is not subject to the provisions of the Delaney clause, FDA says. However, FDA does note that six carcinogenic impurities have been found in commercial certified batches of Red 33 -- 4-aminoazobenzene, 4-aminobiphenyl, aniline, azobenzene, benzidine, and 1,3-diphenyltriazene. The regulation sets forth manufacturing specifications limiting concentrations of the impurities in future batches. "FDA is willing to consider petitions for alternative manufacturing processes," the rule says, "but those petitions should contain evidence that demonstrates that those processes will not produce impurities that will make use of the color additive unsafe." The agency followed a similar course with Red 36, for which one impurity was identified. The Red 33 approval follows an Aug. 2 final rule permanently listing D&C Red 36. Aug. 30 was also to have been the deadline for listing of FD&C Red 3, but in a separate same-day notice, FDA published a proposal to extend that closing date to June 30, 1989. Because the final rules for both Red 33 and Red 36 are not immediately effective, their provisional listing status has been extended to Oct. 28.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth
Sign in to continue reading.
Need a specific report?
1000+ reports available
New to Pink Sheet?
Start a free trial today!
Register for our free email digests: