{"database": "openregs", "table": "federal_register", "rows": [["2016-29588", "Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry; Availability", "Notice", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.\" The guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain. The guidance also describes how trading partners should notify FDA of illegitimate product and sets forth a process for terminating notifications of illegitimate product in consultation with FDA. This guidance also includes a new section, for comment purposes only, that describes when manufacturers should notify FDA of a high risk that a product is illegitimate. Aside from that section, this guidance is a final guidance subsequent to the draft guidance that was issued on June 11, 2014.", "2016-12-09", 2016, 12, "https://www.federalregister.gov/documents/2016/12/09/2016-29588/drug-supply-chain-security-act-implementation-identification-of-suspect-product-and-notification", "https://www.govinfo.gov/content/pkg/FR-2016-12-09/pdf/2016-29588.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled \"Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.\" The guidance addresses provisions...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url", "agency_names", "agency_ids", "excerpts", "regulation_id_numbers"], "primary_keys": ["document_number"], "primary_key_values": ["2016-29588"], "units": {}, "query_ms": 0.33727800473570824, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}