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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-51/
- Published: 2021-08-22T12:00:00.000Z
- Updated: 2026-09-14T17:11:21.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149988

**Ortho-Cept Not Withdrawn Due to Safety/Efficacy: FDA**8/20/2021 *Federal Register* notice: FDA has determined that Janssen Pharmaceuticals Ortho-Cept (desogestrel-ethinyl estradiol) 21- and 28-day oral tablets, 0.15 mg/0.03 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination means that FDA will not begin procedures to withdraw ANDAs that reference the drug product, and it will allow the agency to continue to approve related ANDAs if they meet relevant legal and regulatory requirements. Ortho-Cept is indicated for preventing pregnancy. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-17990.pdf?ref=fdaweb.com).

**Info Collection on Drug Compounding**  
8/20/2021 *Federal Register* notice: FDA has submitted to OMB an information collection revision entitled “Human Drug Compounding, Repackaging, and Related Activities Regarding Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0858). The revision pertains to guidance documents issued in 2017 and 2018 to assist compounders. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-17996.pdf?ref=fdaweb.com).

**Comments Extended for Drug Scheduling Notice**  
8/16/2021 *Federal Register* notice: FDA is reopening the comment period for a 7/23 notice entitled “International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F– MDMB–BICA (4F–MDMB–BUTICA); Brorphine; Metonitazene; Eutylone (bk- EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut.” The comments will be considered in preparing a response from the U.S. to the World Health Organization regarding the abuse liability and diversion of these drugs. WHO will use the information to consider whether to recommend that certain international restrictions be placed on these drug substances. Comments are now being accepted until 8/24\. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-08-16/pdf/2021-17498.pdf?ref=fdaweb.com).