{"description":"Documents matching 'peptides' and published on or after 10/01/2026","count":3,"total_pages":1,"results":[{"title":"Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances","type":"Notice","abstract":"The Secretary of the Department of Health and Human Services (HHS) is announcing the availability of an \"Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances.\" This document describes the Secretary of HHS's enforcement policy regarding the use of certain peptide bulk drug substances in compounding pursuant to section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) while the list of bulk drug substances that can be used in compounding under section 503A of the FD&C Act (the 503A bulks list) is developed through rulemaking.","document_number":"2026-22192","html_url":"https://www.federalregister.gov/documents/2026/10/30/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-30/pdf/2026-22192.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-22192.pdf?1793200509","publication_date":"2026-10-30","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"}],"excerpts":"and data regarding utilization of <span class=\"match\">peptides</span>, HHS believes that there is significant interest in the use of these <span class=\"match\">peptides</span> in compounding given the lack of availability of approved products. Therefore, to expand and improve patient access, HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a <span class=\"match\">peptide</span> bulk drug substance found in Appendix A. FDA's future rulemakings may propose adding some or all of these <span class=\"match\">peptides</span> to the 503A bulks list based on the"},{"title":"Clinical Laboratory Improvement Amendments of 1988 (CLIA); Virtual Access, Gynecologic Cytology Proficiency Testing (PT), Personnel Qualifications, and Other Changes","type":"Proposed Rule","abstract":"This proposed rule would amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to allow for virtual access under the CLIA certificate of the primary testing laboratory that generated the data, with the exception of the subspecialty of cytology, and the use of digital images for gynecologic cytology proficiency testing. This proposed rule also includes proposed changes to personnel qualification requirements and other proposed changes pertaining to SARS-CoV-2 reporting requirements, certificate requirements, test reporting requirements, enforcement requirements, public consultation requirements, and editorial and technical updates. These proposed updates aim to strengthen the Federal oversight of clinical laboratories and ensure accurate and reliable patient test results while adapting to modern technological capabilities and industry needs, including workforce shortages.","document_number":"2026-20613","html_url":"https://www.federalregister.gov/documents/2026/10/08/2026-20613/clinical-laboratory-improvement-amendments-of-1988-clia-virtual-access-gynecologic-cytology","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-10-08/pdf/2026-20613.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-20613.pdf?1791377115","publication_date":"2026-10-08","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Centers for Medicare & Medicaid Services","name":"Centers for Medicare & Medicaid Services","id":45,"url":"https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services","json_url":"https://www.federalregister.gov/api/v1/agencies/45","parent_id":221,"slug":"centers-for-medicare-medicaid-services"}],"excerpts":"Bilirubin, total \n Target value ±20% or ±0.4 mg/dL (greater). \n \n \n Blood gas pCO2 \n Target value ±8% or ±5 mm Hg (greater). \n \n \n Blood gas pO2 \n Target value ±15% or ±15 mmHg (greater). \n \n \n Blood gas pH \n Target value ±0.04. \n \n \n B-natriuretic <span class=\"match\">peptide</span> (BNP) \n Target value ±30%. \n \n \n Pro B-natriuretic <span class=\"match\">peptide</span> (proBNP) \n Target value ±30%. \n \n \n Calcium, total \n Target value ±1.0 mg/dL. \n \n \n Cancer antigen (CA) 125 \n Target value ±20%. \n \n \n Carbon dioxide \n Target value ±20%. \n \n \n Carcinoembryonic antigen (CEA) \n Target value ±15% or 1 ng/mL (greater)"},{"title":"Infant Formula Nutrient Requirements","type":"Proposed Rule","abstract":"The Food and Drug Administration (FDA or we) proposes to amend the regulations on nutrient specifications and labeling for infant formula as part of its phased, comprehensive review of infant formula nutrients. This action, if finalized, would amend the minimum and/or maximum levels of four required nutrients, change the unit of measure for certain nutrients, change the permitted source to meet one of the nutrient requirements, and amend the content of the required labeling. This action also includes a comprehensive assessment of four additional nutrients for which we conclude that the current required levels remain appropriate and reflect the best available scientific evidence on infant nutritional requirements and safe intake levels.","document_number":"2026-22273","html_url":"https://www.federalregister.gov/documents/2026/11/02/2026-22273/infant-formula-nutrient-requirements","pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-11-02/pdf/2026-22273.pdf","public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-22273.pdf?1793286910","publication_date":"2026-11-02","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"excerpts":"that the required sodium levels in § 107.100 remain appropriate. \n 1. Background \n Sodium is an essential nutrient. It plays a critical role in regulating extracellular fluid volume and blood pressure homeostasis, and it is important for the absorption of amino acids, small <span class=\"match\">peptides</span>, and monosaccharides (Refs. 76, 101, 102). Together with chloride and potassium, sodium maintains osmotic and acid-base balance between intracellular and extracellular compartments and is necessary for transporting solutes across membranes and generating electrical signals"}]}