{"database": "openregs", "table": "federal_register", "rows": [["2014-13544", "Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Availability", "Notice", "The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.\" The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The draft guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and terminating notifications regarding illegitimate product. This draft guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable; and for product that has been determined to be illegitimate, or (for manufacturers) has a high risk of illegitimacy, sets forth the process by which trading partners should notify FDA of illegitimate product and how they must terminate the notifications, in consultation with FDA.", "2014-06-11", 2014, 6, "https://www.federalregister.gov/documents/2014/06/11/2014-13544/draft-guidance-for-industry-on-drug-supply-chain-security-act-implementation-identification-of", "https://www.govinfo.gov/content/pkg/FR-2014-06-11/pdf/2014-13544.pdf", "Health and Human Services Department; Food and Drug Administration", "221,199", "The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.\" The draft guidance addresses new...", null]], "columns": ["document_number", "title", "type", "abstract", "publication_date", "pub_year", "pub_month", "html_url", "pdf_url",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": ["2014-13544"], "units": {}, "query_ms": 15.143139054998755, "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"}