Current Regulations on Drug Storage Equipment at Retail Pharmacies

Please help clarify this question for me: How are the devices used to store medications at retail drug establishments currently regulated?

Based on Subsection 4.5.2.3, Section 4.5, Chapter IV of the Practical Handbook at Retail Pharmacies (Issued together with Decision 696/QD-QLD in 2021), the regulations on drug storage equipment at retail pharmacies are as follows:

Adequate equipment is required to store drugs to prevent adverse effects from light, temperature, humidity, contamination, and insect intrusion, including:

- Sturdy, smooth, easy-to-clean cabinets, counters, and shelves convenient for displaying, storing drugs, and ensuring aesthetics.

- Sufficient lighting to ensure operations, verify information on drug labels, and avoid confusion.

- Thermometers and hygrometers to monitor temperature and humidity at the retail pharmacy. Thermometers and hygrometers must be periodically calibrated as required. At least one automated temperature monitoring device with an appropriate recording frequency (generally once or twice per hour depending on the season) must be equipped.

Storage equipment suitable for the storage requirements indicated on the drug label. Room temperature storage conditions: temperature not exceeding 30°C, humidity not exceeding 75%.

- A refrigerator or suitable cold storage means must be available for drugs requiring cool (8-15°C) or cold (2-8°C) storage.

Appropriate dispensing tools and packaging materials for drug preservation, including:

- In cases where drugs are dispensed without the primary packaging directly contacting the drug, airtight packaging; sufficiently rigid to protect the drug, and with a tight seal must be used.

- Do not use dispensing packaging containing advertisements for other drugs as drug containers.

- External drugs and specially regulated drugs need to be packaged suitably and distinguished easily.

- Compounded prescription drugs need to be stored in pharmaceutical packaging to avoid affecting drug quality and can be easily distinguished from non-drug products like beverages/foods/household products (applies to pharmacies).

Drug Labeling:

- For retail drugs not contained in the drug's outer packaging, clearly state: drug name; dosage form; concentration, strength of the drug; in the absence of a prescription, dosage, frequency, and method of use must be added.

- Compounded prescription drugs at pharmacies: in addition to the above stipulations, the following must be added: compounding date; expiration date; patient name; name and address of the compounding pharmacy; safety warnings for children (if any) (applies to pharmacies).

Sincerely!

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