Core Viewpoint - The article emphasizes the importance of having FDA documentation for products exported to the United States to avoid customs issues such as detention, delays, or returns. It provides guidance on which products require FDA documentation and how to handle situations when such documents are missing. Group 1: Products Requiring FDA Documentation - The FDA has strict regulations on imported goods, particularly for categories such as food, dietary supplements, medical devices, cosmetics, and pet food [1][3][4][5][11]. - Specific requirements include FDA registration numbers, Device Listings, Prior Notices, and safety testing reports for various product types [4][5][6][11]. Group 2: Consequences of Missing FDA Documentation - Missing FDA documents can lead to customs detention, which may require additional documentation and result in delays ranging from days to weeks [7]. - In severe cases, goods may be returned to the sender or destroyed if compliance documents are not provided in a timely manner [8]. Group 3: Emergency Handling Methods - Immediate contact with the importer or seller to submit missing documents is crucial [9]. - Engaging a customs clearance company and ensuring accurate invoice information can facilitate the process [9]. - Utilizing a Power of Attorney (POA) allows customs brokers to submit documents on behalf of the importer if direct submission is not possible [9]. Group 4: Preventive Measures - Preparing necessary documents in advance is essential to avoid customs issues [10]. - Key documents include FDA registration, Device Listings, safety test reports, and accurate invoices detailing product information [12]. - Using DDP (Delivered Duty Paid) shipping can help ensure that duties and fees are pre-paid, facilitating smoother customs clearance [12].

Industry Overview - The pharmaceutical distribution industry serves as a critical link between pharmaceutical manufacturers and end consumers, characterized by a specialized division of labor [2][5] - The industry consists of upstream manufacturers producing various types of pharmaceutical products, including Western medicine, traditional Chinese medicine, medical devices, and chemical reagents [1] Cost Structure Analysis - The primary cost in the pharmaceutical distribution industry is sales cost, which includes product and raw material costs, accounting for approximately 95% of total sales costs, while other costs make up about 5% [5] Profitability Factors - Key drivers of profitability in the pharmaceutical distribution sector include sales scale and growth, gross margin levels, expense ratios, and inventory turnover [7] - Companies maintain stable gross margins through scale advantages and product structure adjustments, while controlling costs through refined management practices [7] Internet Integration - The integration of "Internet+" in the pharmaceutical distribution industry helps reduce costs and improve efficiency, allowing pharmaceutical companies to analyze order demands and pharmacies to manage inventory effectively [9] - Patients benefit from the ability to compare prices and brands online, facilitating informed purchasing decisions [9]