{"abstract":"The Food and Drug Administration (FDA) is announcing that orally administered drug products containing levothyroxine sodium are new drugs. There is new information showing significant stability and potency problems with orally administered levothyroxine sodium products. Also, these products fail to maintain potency through the expiration date, and tablets of the same dosage strength from the same manufacturer vary from lot to lot in the amount of active ingredient present. This lack of stability and consistent potency has the potential to cause serious health consequences to the public. Manufacturers who wish to continue to market orally administered levothyroxine sodium products must submit new drug applications (NDA's); manufacturers who contend that a particular drug product is not subject to the new drug requirements of the Federal Food, Drug, and Cosmetic Act (the act) should submit a citizen petition. FDA has determined that orally administered levothyroxine sodium products are medically necessary, and accordingly the agency is allowing current manufacturers 3 years to obtain approved NDA's.","action":"Notice.","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"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/1997/08/14/97-21575.html","cfr_references":[],"citation":"62 FR 43535","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"August 14, 1997.","disposition_notes":null,"docket_ids":["Docket No. 97N-0314"],"dockets":[],"document_number":"97-21575","effective_on":"1997-08-14","end_page":43538,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1997/08/14/97-21575/prescription-drug-products-levothyroxine-sodium","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/97-21575?publication_date=1997-08-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1997-08-14/97-21575/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":446,"last_updated":"2026-09-22 12:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1997-08-14/pdf/97-21575.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1997-08-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1997/08/14/97-21575.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":43535,"subtype":null,"title":"Prescription Drug Products; Levothyroxine Sodium","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":62}