Nationwide Crackdown on Traditional Chinese Medicine Herbal Pieces: How Pharmacy Staff Are Responding

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Recently, the "Gualou substandard drug case" was fined 1.11 million yuan, while products such as Haishen, Baitouweng, and Hawthorn were also penalized or warned due to不合格 (non-compliant) characteristics or moisture content.

Multiple regions have launched special crackdowns on traditional Chinese medicine decoction pieces. How can pharmacy staff stay competitive, and how can decoction-piece dispensers enhance their professional expertise?

The new versions of the "Drug Law" and the "Pharmacopoeia" elevate regulation to a new level.

On July 2, the 2020 edition of the *Pharmacopoeia of the People's Republic of China* was reviewed, approved, and officially released by the National Medical Products Administration in collaboration with the National Health Commission, coming into effect on December 30, 2020.

The new edition of the Pharmacopoeia has set forth new requirements for the traditional Chinese medicine decoction piece industry, imposing stringent management standards on all stages—including processing and distribution enterprises—to ensure the quality of these medicinal materials. Additionally, the 2019 version of the Drug Administration Law has also strengthened penalties for counterfeit and substandard drugs.

Due to the unique characteristics of traditional Chinese medicine slices, attributes such as appearance, moisture content, and ash levels can significantly impact product quality. Taking the "Gu Lou Substandard Medicine Case" as an example, the handling personnel noted that the Gu Lou purchased and sold by the parties involved, upon inspection, exhibited an 【appearance】where the outer surface was described as "immature dark green, ... not adhering tightly to the seeds in clumps, with numerous seeds visibly present." This clearly contradicts the pharmacopoeia standard, which specifies that the outer surface should be "orange-red or orange-yellow, ... firmly adhering to most seeds in cohesive clumps." Such discrepancies in appearance could easily be detected during the routine, standard acceptance procedures conducted by inspectors. However, the parties failed to fulfill their legal duties, resulting in the substandard Gu Lou being accepted into inventory and subsequently sold.

Additionally, the 2020 edition of the *Chinese Pharmacopoeia* explicitly mandates that 33 prohibited pesticides, including methamidophos, must not be detected at all (i.e., their levels must remain below the limit of quantification), and these requirements have been incorporated into the General Rules for Testing of Crude Drugs and Herbal Pieces. This means that Chinese medicinal herbs and herbal preparations will now face even stricter regulatory oversight.

Pharmacist shares experience: The state is tightening its management of traditional Chinese medicinal materials, with increased inspection efforts. Moreover, the new Drug Administration Law has significantly intensified penalties for counterfeit and substandard drugs. As pharmacies serve as the final checkpoint in the distribution chain of these materials, they must take full responsibility to ensure people’s medication safety. Given the enhanced regulatory standards, pharmacy staff should strictly adhere to all national requirements.

The experience from the pharmacy where I work is that each pharmacy's inspector should, whenever possible, carefully open and thoroughly examine the packaging bags during acceptance checks. In fact, seasoned pharmacists can often spot the authenticity and quality grade of herbal medicines at a glance based on their extensive experience—especially since the headquarters of chain companies also have dedicated quality-control personnel who conduct rigorous inspections to ensure compliance.

Improving professional standards starts with trait identification.

From recent inspections, it's evident that the examination typically focuses on the physical characteristics of herbal slices. Identifying these characteristics is the most fundamental skill—and one that dispensing pharmacists must master. In fact, once the herbal slices are delivered to pharmacies, the quality-checking process conducted by inspectors represents the final checkpoint in the entire distribution chain. At this critical stage, dispensing pharmacists should maintain strict vigilance, ensuring that no lapses occur simply because quality control has already been handled by previous staff members.

All dispensing pharmacists should be familiar with the basic knowledge of physical characteristic identification, carefully examining the shape, size, color, surface features, texture, cross-sectional characteristics, as well as the aroma, taste, and results from water and fire tests of herbal slices. Do not underestimate the importance of physical characteristic differentiation—some herbal slices look remarkably similar, requiring meticulous identification to tell them apart, such as Cinnamomi Ramulus versus Clematis armandii, or Rehmanniae Praeparata versus Polygonati Odorati Praeparata, and so on.

Pharmacy professionals should prioritize learning knowledge about herbal medicine preparations, enhancing their expertise and rigorously ensuring quality control. In fact, all dispensers of herbal medicines must master the relevant knowledge before they can officially take up their roles. The state has always maintained strict regulations regarding the qualifications and working conditions of herbal medicine sales personnel—only trained individuals are permitted to handle Chinese medicinal herb preparations. Moreover, even if you’re qualified to dispense herbal medicines, it’s essential to engage in diligent, ongoing learning to continuously elevate your professional competence.

For example, when it comes to identifying medicinal materials based on their characteristics, the cross-sectional features of processed herbs—such as whether the cut surface is smooth, fibrous, granular, or flaky; whether they contain gelatinous strands; whether they can be peeled off in layers; and whether radial patterns are present—can help distinguish many types of traditional Chinese medicine preparations. In a sense, being a herbal preparation technician is indeed a profession that requires lifelong learning.

Pharmacist’s Experience Sharing: Identifying the characteristics of herbal slices is the most commonly used method among dispensers, as the appearance and physical traits of these slices can roughly determine whether they are genuine medicines—or counterfeit and substandard products.

When preparing Chinese medicinal herbs, the author sometimes finds it difficult to distinguish between Rehmannia glutinosa and Scrophularia ningpoensis based on their appearance alone—this is where scent comes in handy for identification. Rehmannia has a faint, pleasant fragrance, while Scrophularia emits a distinctive aroma that slightly resembles caramel. With this simple olfactory clue, the two can easily be told apart.

Daily training is essential.

Pharmacy staff training isn’t just for show—it’s like military drills, requiring real commitment and effort. In addition to developing annual training plans, pharmacy professionals should also promptly update and revise their programs in line with national policies.

For herbal medicine dispensers, pharmacy training should align closely with the nature of their work—covering topics such as the proper arrangement rules for medicinal herb formulas, contraindications in Chinese medicine combinations, and clear instructions on special preparation methods like first decocting, adding later, wrapping for decoction, separate decoction, dissolving, and mixing medications. It also includes mastering both the standard and alternate names of herbs, as well as following the typical dispensing procedure: reviewing prescriptions—calculating costs—compounding—double-checking—packaging—and finally dispensing the medication. Although the daily tasks of a herbal medicine dispenser may seem monotonous, they must be carried out precisely according to the established workflow.

The training for herbal medicine dispensers differs from that of general pharmaceutical staff. In addition to learning how to identify the authenticity of herbal ingredients, dispenser training also covers the entire dispensing process, with a strong emphasis on practical, hands-on skills. There are plenty of everyday examples: when the quality of herbal medicines is assured, but sales staff fail to properly prepare or dispense them—leading customers to perceive your service as unprofessional—customers are likely to walk away. That’s why herbal medicine training should begin with regular, real-world practice sessions to build both confidence and competence.

Pharmacist Experience Sharing: Training for herbal medicine dispensers should still begin with hands-on practice specific to their roles. The company I work for regularly holds role-playing competitions, divided into two parts—dispensing Western medicines and dispensing traditional Chinese herbal formulas.

Generally, the process begins with a theoretical exam, which is prepared by professional experts and administered under closed-book, proctored conditions—often following the same rigorous supervision model used in standardized school exams like the Gaokao. After the theoretical test results are released, candidates are ranked based on their scores from highest to lowest, followed by an on-site practical exam. Finally, a comprehensive ranking is determined by combining both the theoretical and practical scores, with top performers receiving well-deserved rewards. This regular training and hands-on practice are highly beneficial for enhancing the professional skills of Chinese medicine dispensing technicians.