USP 659草案修订：药品受控室温统一为15–25℃

On July 1, 2026, the United States Pharmacopeia (USP) officially released the revised draft of <659> Packaging and Storage Requirements, issuing a critical update on the core pharmaceutical storage index — Controlled Room Temperature (CRT). The long-standing CRT range of 20℃–25℃ has been adjusted to 15℃–25℃, fully aligning with mainstream international pharmacopeia standards including WHO, EP and JP.

2026年7月1日，美国药典（USP）正式发布《659 包装与储存条件要求》修订草案，针对药品储存核心指标——受控室温（CRT）发布关键性更新。沿用多年的受控室温区间由20℃～25℃调整为15℃～25℃，全面接轨WHO、欧洲药典、日本药局方等主流国际药典标准。

As a core general chapter governing the full lifecycle of pharmaceutical packaging, storage and distribution, USP <659> guides compliance operations for global pharmaceutical manufacturers, warehouses and logistics enterprises. This revision is not a simple numerical adjustment, but a systematic optimization based on scientific stability evidence, global supply chain practice and sustainable development goals, which will profoundly affect pharmaceutical temperature control, logistics compliance, quality judgment and international trade rules.

USP 659作为管控药品包装、储存、分销全流程的核心通则，指导全球药企、医药仓储及流通企业的合规运营。本次修订并非简单的数值调整，而是基于科学稳定性数据、全球供应链现状与可持续发展目标的系统性优化，将深刻影响药品温控管理、物流合规、质量判定及国际贸易准则。

1. Revision History: Iteration of USP Controlled Room Temperature Standards 

修订溯源：USP受控室温标准迭代历程

The definition of USP Controlled Room Temperature (CRT) has undergone two major iterations, and the 2026 update represents upgraded scientific cognition and industrial development needs.

USP受控室温（CRT）定义历经两次关键迭代，本次2026年修订是科学认知升级与行业发展需求的必然结果。

1. USP 18 (1970): First established the CRT definition as 15℃–30℃ (59℉–86℉). The broad range adapted to the early extensive operation mode of pharmaceutical storage and distribution.

1970年 USP 18版本：首次确立受控室温定义，温度区间为15℃～30℃（59℉～86℉），宽泛区间适配早期医药仓储流通的粗放式运营模式。

2. USP 22–NF 17 Supplement 9 (1990): Tightened the core constant CRT range to 20℃–25℃ (68℉–77℉), while permitting temporary temperature excursions of 15℃–30℃ for pharmacy, hospital and warehouse environments. Meanwhile, Mean Kinetic Temperature (MKT) was introduced as the core assessment indicator for temperature deviations, with a maximum MKT limit of 25℃. This revision was synchronized with the update of USP <1151> Pharmaceutical Dosage Forms stability chapter.

1990年 USP 22–NF 17补编：将CRT核心恒温区间收紧至20℃～25℃（68℉～77℉），同时允许药房、医院、仓库场景下15℃～30℃的临时温度波动。同步引入平均动力学温度（MKT）作为温度偏移核心判定指标，限定MKT计算值不得超过25℃。本次修订与USP〈1151〉药品剂型稳定性通则更新同步落地。

3. USP <659> Draft (July 2026): Aligned with global unified pharmacopeia standards, the formal constant CRT range is revised to 15℃–25℃. The mature MKT evaluation system and excursion control rules are fully retained without changing the original compliance judgment logic, achieving balanced optimization of product safety, global harmonization, energy saving and sustainability.

2026年7月 USP 659草案：对标全球统一药典标准，将受控室温恒定区间正式修订为15℃～25℃。完整保留成熟的MKT评判体系与波动管控规则，不改变原有合规判定逻辑，实现药品安全、全球合规统一、节能降本的多维平衡升级。

2. Core Revision Rationale 

五大核心修订依据

his standard adjustment is fully supported by scientific evidence, industrial practice and global policy, with five core rationales catering to high-quality pharmaceutical industry development.

本次标准调整具备充分的科学依据、行业实践与政策支撑，五大核心修订理由全面适配医药行业高质量发展需求。

2.1 Energy Cost Efficiency

Maintaining the previous 20℃–25℃ CRT range imposes substantial energy burdens, especially in cold climate regions. For example, winters in the northern United States often drop below 0℃, requiring continuous intensive heating to sustain the 20℃ minimum temperature, resulting in high energy consumption and operational costs. Lowering the minimum temperature to 15℃ significantly reduces heating demand and operational expenses in cold seasons.

2.1 降本提效：原有20℃～25℃的温控标准对寒冷地区能耗压力极大。以美国北部为例，冬季气温常低于0℃，为维持20℃以上恒温需持续高强度供暖，能耗与运维成本居高不下。本次下限下调至15℃，可大幅降低寒冷季节供暖负荷与运营成本。

2.2 Environmental Sustainability

Harmonized room temperature standards reduce overall energy consumption and carbon footprints of the pharmaceutical industry. The unified temperature specification supports global climate change mitigation strategies and enhances the environmental responsibility of pharmaceutical manufacturing and logistics sectors.

2.2 低碳环保：统一室温标准可降低医药行业整体能耗与碳足迹，契合全球气候变化治理目标，提升医药生产、流通环节的环境可持续性与行业责任担当。

2.3 Global Supply Chain Consistency

Historical discrepancies between USP (20–25℃) and WHO/EP/JP (15–25℃) created dual compliance standards for cross-border pharmaceutical trade, increasing logistical complexity and compliance costs. This revision eliminates regional standard barriers, simplifies global distribution, and facilitates consistent international supply chain operation.

2.3 全球协同：以往USP与WHO、EP、JP室温标准不统一，形成跨境药品「双重合规体系」，大幅增加国际贸易物流复杂度与合规成本。本次修订彻底消除区域标准壁垒，简化全球分销流程，助力供应链高效协同。

2.4 Drug Safety and Stability

Scientific temperature mapping data and stability studies confirm that pharmaceutical products maintain full stability within 15℃–25℃. Lowering the temperature lower limit does not significantly accelerate drug degradation or compromise safety and efficacy. The revised range aligns with ICH Q1A(R2) globally harmonized stability conditions, including intermediate stability (30℃±2℃ / 65%±5% RH) and accelerated stability (40℃±2℃ / 75%±5% RH) for 6 months. Although ICH Q1A(R2) does not explicitly define MKT, USP excursion limits are consistent with the temperature tolerance range specified in ICH stability guidelines.

2.4 质量安全：温度分布数据与药品稳定性研究证实，15℃～25℃区间可充分保障药品稳定性，下调温度下限不会加速药品降解、不影响药品安全性与有效性。本次温度区间完全匹配ICH Q1A(R2)全球稳定性试验规范，涵盖中长期稳定性（30℃±2℃、相对湿度65%±5%）与加速稳定性（40℃±2℃、相对湿度75%±5%）6个月试验条件。尽管ICH Q1A(R2)未单独定义MKT，但USP温度波动限值与该准则耐受区间高度契合。

2.5 Reduction of Pharmaceutical Wastage

Inconsistent regional temperature standards previously caused unreasonable pharmaceutical discarding. For instance, products stored steadily at 18℃ may comply with WHO/EP standards but fail the old USP criteria, resulting in unnecessary disposal of safe and effective medicines, causing both economic loss and environmental waste.

2.5 减少损耗：过往区域温控标准差异易造成合规判定矛盾。例如18℃储存的合格药品，可符合WHO、EP标准却不符合旧版USP规范，导致有效药品被无端报废，造成经济损失与医药废弃物污染。

3. Global Pharmacopeia Temperature Standard Comparison

全球主流药典室温标准对标

After the 2026 USP revision, major global pharmacopeias have basically unified room temperature specifications, while the Chinese Pharmacopoeia maintains differentiated provisions.

本次USP修订后，全球主流药典室温储存标准基本实现大一统，仅中国药典保留差异化温控体系。

• USP 659 (Draft): Controlled Room Temperature (CRT): 15℃–25℃, MKT rules retained
  

  美国药典（USP 659草案）：受控室温15℃～25℃，保留MKT波动判定规则

• EP (European Pharmacopoeia): Room temperature: 15℃–25℃
  

  欧洲药典（EP）：室温15℃～25℃

• WHO (TRS 1025 Annex 7): Room temperature: 15℃–25℃
  

  世界卫生组织（WHO TRS 1025附录7）：室温15℃～25℃

• JP (Japanese Pharmacopoeia): Cold: 1℃–15℃; Standard temperature: 20℃; Room temperature: 15℃–25℃. The wider lower limit provides operational flexibility for vaccines and biologics during cold seasons.
  

  日本药局方（JP）：冷藏1℃～15℃、标准温度20℃、室温15℃～25℃；宽松下限为疫苗、生物制品冬季储存提供更高操作弹性

• ICH: No explicit definition of room temperature; the revision fully complies with ICH harmonization principles
  

  ICH协调准则：无专属室温定义，本次修订完全契合ICH全球质量协调原则

• Chinese Pharmacopoeia (Current): Normal temperature: 10℃–30℃; Cool place: ≤20℃; Dark cool place: ≤20℃ (light-proof); Cold place: 2℃–10℃
  

  中国药典（现行）：常温10℃～30℃；阴凉处≤20℃；凉暗处（避光）≤20℃；冷处2℃～10℃

  
  

4. Key Operational & Compliance Rules (Unchanged) 

核心实操合规规则（保持不变）

This revision only adjusts the constant CRT range. All core compliance judgment mechanisms and temperature excursion control requirements remain unchanged to minimize enterprise compliance transformation costs.

本次修订仅调整受控室温恒定区间，所有核心合规判定机制、温度波动管控要求均保持不变，最大限度降低企业合规改造成本。

4.1 MKT Evaluation Principle

Mean Kinetic Temperature (MKT) remains the core indicator for evaluating short-term temperature excursions above 25℃. Only the lower constant temperature limit is adjusted from 20℃ to 15℃; all MKT calculation logics, thresholds and judgment criteria are unchanged.

4.1 MKT判定原则不变：平均动力学温度（MKT）仍为评估25℃以上短期温度波动的核心指标。仅恒温下限由20℃下调至15℃，MKT计算逻辑、阈值、判定标准完全沿用旧版规则。

4.2 Data Documentation & Observation Period

All temperature monitoring data and calculated MKT values must be fully documented and traceable. MKT calculation shall adopt all valid temperature data during the observation period, defined as the entire duration the products are held by the custodian. If the exact storage duration is unknown (e.g., general warehouse storage), the observation period defaults to 30 days, supported by temperature mapping data and typical U.S. warehouse turnover cycles.

4.2 数据存档与观测周期：所有温度监测原始数据、MKT计算结果必须完整存档、全程可追溯。MKT计算需纳入观测周期内全部有效数据；观测周期为药品保管方全程持有时长，无法精准判定时长的仓库场景，统一默认按30天计算，该规则有温度映射数据与美国仓库常规周转实践支撑。

4.3 Temperature Excursion Duration & Offset Rules

Specified by USP <1079.2>: The maximum allowable duration for a single temperature excursion outside the CRT range is 24 hours. Storage time under controlled cold or cool conditions cannot be used to offset out-of-CRT temperature excursions.

4.3 波动时长与抵扣规则（依据USP〈1079.2〉）：单次超出受控室温区间的温度波动最长允许时长为24小时；受控冷藏、阴凉储存时长不得冲抵、抵消超出CRT区间的温度波动时长。

4.4 Editorial Format Optimization

Minor editorial revisions are implemented to align the chapter format with the current USP stylistic specifications.

4.4 格式规范优化：本次草案同步完成少量文字编辑与体例优化，适配现行USP药典格式规范。

5. Industrial Impact & Compliance Implications 

行业影响与合规启示

The USP <659> revision marks a milestone of global standardization, green development and harmonization for pharmaceutical quality control.

本次USP 659修订是全球医药质量标准化、绿色化、协同化发展的里程碑事件。

For export pharmaceutical enterprises: Eliminates cross-border temperature standard barriers, unifies global storage requirements, and simplifies cross-border supply chain compliance management.

对出口药企：彻底打通跨境温控标准壁垒，统一全球储存要求，简化国际供应链合规管理。

For pharmaceutical warehousing and logistics enterprises: Optimizes heating energy consumption in cold regions, reduces operational costs, and realizes win-win compliance and energy efficiency.

对仓储流通企业：优化寒冷地区供暖能耗，降低运维成本，实现合规与节能双赢。

For quality management: Expands temperature flexibility based on solid stability data, avoids unreasonable product scrapping, and balances safety and operational flexibility.

对质量管控：在稳定性数据支撑下提升温控灵活性，杜绝无意义药品报废，兼顾质量安全与运营弹性。

For domestic Chinese pharmaceutical industry: Highlights Sino-foreign pharmacopeia differences and provides reference for China’s pharmaceutical storage standard upgrading and international docking.

对国内医药行业：凸显中外药典温控差异，为国内药品储存标准升级、对接国际规范提供重要参考。

6.参考文献：

1. United States Pharmacopeia. "Controlled room temperature" as defined under Preservation, Packaging, Storage, and Labeling in General Notices. In: USP 18; 1970.

2. United States Pharmacopeia. "Controlled room temperature" as defined under Preservation, Packaging, Storage, and Labeling in General Notices. In: USP 22–NF 17, Supplement 9; 1990.

3. United States Pharmacopeia. Pharmaceutical Dosage Forms 〈1151〉. In: USP 22–NF 17, Supplement 9; 1990.

4. Pharmaceuticals and Medical Devices Agency. General Notices. In: Japanese Pharmacopeia 18^th Edition; 2021.

5. Ministry of Health, Labour and Welfare of Japan (MHLW). Storage and Handling of Pharmaceuticals; 2019.

6. European Directorate for the Quality of Medicines & HealthCare (EDQM). General Notices. In: European Pharmacopoeia 11^th Edition; 2023.

7. World Health Organization (WHO). Good storage and distribution practices for medical products. Annex 7. WHO Technical Report Series, No. 1025; 2020. https://www.who.int/publications/m/item/trs-1025-annex-7.

8. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Q1A(R2): Stability Testing of New Drug Substances and Products. 2003. https://www.ich.org/page/quality-guidelines.

9. United States Pharmacopeia. Packaging and Storage Requirements 〈659〉. In: USP–NF; 2024.

10. Intergovernmental Panel on Climate Change (IPCC). Climate Change 2021: The Physical Science Basis; 2021. https://www.ipcc.ch/report/ar6/wg1/.

11. United Nations Conference on Trade and Development. Global Supply Chains: Trade and Economic Policies for Developing Countries. Policy Issues in International Trade and Commodities Study Series No. 55. United Nations; 2013.

12. World Health Organization (WHO). WHO guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products. Annex 10. WHO Technical Report Series, No. 1010; 2020. https://www.who.int/publications/m/item/trs1010-annex10.

13. World Health Organization (WHO). WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products; 2017. https://www.who.int/publications/i/item/9789241513425.