OTC 与药品OTC & Drugs

企业注册与药品列名：时限是硬杠杠Establishment Registration & Drug Listing: Deadlines Are Hard Rules

在美国生产、加工、包装、贴标药品（含 OTC）的境内外企业，须按 21 CFR Part 207 完成注册与列名。FDA 对这几个时限卡得很严，逾期可能收到警告信或面临合规行动：Domestic and foreign establishments manufacturing, processing, packing, or labeling drugs (including OTC) in the US must register and list under 21 CFR Part 207. FDA enforces these deadlines strictly — missing them can trigger warning letters or compliance action:

• 5天企业注册：Establishment registration: 开始相关业务后 5 天内完成注册。Within 5 days of beginning relevant operations.
• 3天药品列名：Drug listing: 初始企业注册后 3 天内完成药品列名。Complete drug listing within 3 days of initial establishment registration.
• 年年度更新：Annual update: 每年 10 月 1 日–12 月 31 日完成年度更新与认证；每年 6 月、12 月复核列名信息。Every October 1 – December 31: annual update and certification; review listing information each June and December.

• 境外企业必须指定美国代理人（US Agent）作为 FDA 联络人。Foreign establishments must designate a US Agent as FDA liaison.
• 注册信息、列名信息有任何变更，须按规定时限更新，不能拖到年底。Any changes to registration or listing information must be updated within the required timeframes — don't wait until year-end.

NDC 码 12 位新规The 12-Digit NDC Rule

FDA 在 2026 年 3 月发布终规：NDC 码统一为 12 位（6-4-2 格式），这是几十年来最大的一次格式调整。In March 2026, FDA published the final rule: NDC numbers move to a uniform 12-digit (6-4-2) format — the biggest format change in decades.

• ✓生效：Effective: 2033 年 3 月 7 日。March 7, 2033.
• ✓节奏：Timeline: 2026–2033 共 7 年准备期，2033–2036 共 3 年过渡期。A 7-year preparation period (2026–2033) plus a 3-year transition (2033–2036).
• ✓影响：Impact: ERP / 标签系统升级、条码切换（一维 / 二维二选一）、DSCSA 主数据同步——现在就该开始规划。ERP / label system upgrades, barcode switching (linear or 2D), DSCSA master-data alignment — planning should start now.

查看法规动态里的详细解读Read the detailed analysis in Regulatory Updates →

OTC 药品路径与 OMUFA 费用OTC Pathways & OMUFA Fees

多数 OTC 药品按 FDA 的 OTC 专论（monograph）上市，无需逐产品审批，但企业注册、药品列名、标签（Drug Facts）一样都不能少。专论路径下的生产设施须缴纳 OMUFA（非处方药使用者费用）设施费：Most OTC drugs are marketed under FDA's OTC monographs without per-product approval — but establishment registration, drug listing, and Drug Facts labeling are all still required. Manufacturing facilities under the monograph pathway pay OMUFA (Over-the-Counter Monograph User Fee) facility fees:

设施类型Facility Type	FY2027 年费FY2027 Annual Fee	说明Notes
MDF（专论药品设施）MDF (monograph drug facility)	$47,891	生产专论药品的设施缴纳。Paid by facilities manufacturing monograph drugs.
CMO（合同生产组织）CMO (contract manufacturing organization)	$31,927	合同生产组织缴纳。Paid by contract manufacturing organizations.

以上为 FDA 官方费用，每年调整；是否适用 OMUFA 取决于你的生产模式，我们会在评估时帮你确认。These are official FDA fees, adjusted yearly. Whether OMUFA applies depends on your manufacturing model — we confirm this during evaluation.

标签与供应链Labeling & Supply Chain

OTC 药品标签须采用统一的 Drug Facts 格式；处方药标签按批准文件执行。供应链方面，DSCSA（药品供应链安全法）要求处方药建立可追溯体系，相关主数据须与 NDC 12 位切换同步规划。OTC drug labels must use the uniform Drug Facts format; prescription drug labeling follows the approval documents. On the supply chain side, DSCSA (Drug Supply Chain Security Act) requires traceability for prescription drugs, and related master data must be planned alongside the 12-digit NDC transition.

• Drug Facts：适应症、用法用量、警示语格式固定，逐项核对。Drug Facts: indications, directions, and warnings follow fixed formats — checked item by item.
• NDC 12 位切换会影响条码与 DSCSA 产品标识，建议提前做系统评估。The 12-digit NDC switch affects barcodes and DSCSA product identifiers — assess your systems early.

这项服务包含什么What's Included in This Service