Schedule H1 Drug Register Format | Rule 65(3)(1)(h) [FREE PDF]
Rule 65(3)(1)(h) of the Drugs Rules, 1945 requires Schedule H1 supplies to be recorded in a separate register at the time of supply. The record must be kept for three years and remain open for inspection.
- Industry: Healthcare / Pharmacy
- Frequency: At each Schedule H1 supply
- Estimated Time: 1-2 minutes per entry
- Role: Registered Pharmacist / Pharmacy Licence Holder
- Total Items: 13
- Compliance: Drugs Rules 1945 Rule 65(3)(1)(h), Drugs Rules 1945 Schedule H1, G.S.R. 588(E), 30 August 2013
Schedule H1 statutory register format
Rule 65(3)(1)(h) requires these five particulars to be recorded in a separate register at the time of supply. Keep the record for three years and open for inspection.
| Supply date and time (operational, not statutory) | Prescriber name | Prescriber address | Patient name | Drug name | Quantity supplied |
|---|---|---|---|---|---|
Supply date and time appears beside the statutory particulars for day-to-day use. It is an operational field, not one of the five particulars required by Rule 65(3)(1)(h).
Particulars required by Rule 65(3)(1)(h)
Enter these particulars in a separate register at the time a Schedule H1 drug is supplied.
- Prescriber name
- Prescriber address
- Patient name
- Drug name
- Quantity supplied
Operational field alongside the statutory particulars
Supply date and time appears beside the five statutory particulars for day-to-day use. It is not required by Rule 65(3)(1)(h).
- Supply date and time (operational, not statutory)
Optional operational fields
These fields may help with retrieval and stock reconciliation. They are not stated as mandatory particulars in Rule 65(3)(1)(h).
- Internal record ID
- Prescription/reference number
- Manufacturer
- Batch number
- Expiry date
- Pharmacist name or signature
- Operational notes
Reviewer notes
From the reviewer. Akshay Tupe (B. Pharm, MSPC Reg. 468872) recommended three refinements to the format we published:
- Add a prescription or reference number field so entries are traceable to the source prescription.
- Label the supply date and time column clearly as an operational field so auditors can distinguish it from the five statutory particulars.
- Widen the prescriber address and drug name columns; both fields regularly exceed a single narrow column in dispensing practice.
All three refinements are reflected in the register format and the downloadable PDF above.
Primary source: Drugs Rules, 1945, Rule 65(3)(1)(h), read with Schedule H1 and G.S.R. 588(E), 30 August 2013. Open the CDSCO compilation
Reviewed by Akshay Tupe, B. Pharm, registered pharmacist, Maharashtra State Pharmacy Council, registration 468872.
Open the Schedule H1 pharmacy audit checklist
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Why Use This Schedule H1 Drug Register Format | Rule 65(3)(1)(h) [FREE PDF]?
This schedule h1 drug register format | rule 65(3)(1)(h) [free pdf] helps healthcare / pharmacy teams maintain compliance and operational excellence. Designed for registered pharmacist / pharmacy licence holder professionals, this checklist covers 13 critical inspection points across 3 sections. Recommended frequency: at each schedule h1 supply.
Ensures compliance with Drugs Rules 1945 Rule 65(3)(1)(h), Drugs Rules 1945 Schedule H1, G.S.R. 588(E), 30 August 2013. Regulatory-aligned for audit readiness and inspection documentation.
Frequently Asked Questions
What is a Schedule H1 Drug Register Format | Rule 65(3)(1)(h) [FREE PDF]?
A Schedule H1 Drug Register Format | Rule 65(3)(1)(h) [FREE PDF] is a standardized form used by registered pharmacist / pharmacy licence holder to ensure consistent healthcare / pharmacy operations. It contains 13 fields organized into 3 sections. FREE Schedule H1 drug register format under Rule 65(3)(1)(h). Printable pharmacy record with verified statutory fields. Download FREE template now.
How often should I use this healthcare / pharmacy checklist?
This checklist is designed to be completed at each schedule h1 supply. Regular use ensures compliance with Drugs Rules 1945 Rule 65(3)(1)(h) and Drugs Rules 1945 Schedule H1 and helps identify issues before they become problems.
Can I download this Schedule H1 Drug Register Format | Rule 65(3)(1)(h) [FREE PDF] as a PDF?
Yes, you can download this checklist as a FREE PDF for printing or offline use. The checklist includes 13 fields across 3 sections and typically takes 1-2 minutes per entry to complete.
What compliance standards does this checklist cover?
This checklist helps ensure compliance with Drugs Rules 1945 Rule 65(3)(1)(h), Drugs Rules 1945 Schedule H1, G.S.R. 588(E), 30 August 2013. Following these standards protects your organization and ensures best practices.
How do I complete this healthcare / pharmacy checklist?
Work through each of the 3 sections, completing the fields in each section. The entire process takes approximately 1 to 2 minutes per entry.
What are the key sections in this healthcare / pharmacy checklist?
This healthcare / pharmacy checklist is organized into 3 key sections: Particulars required by Rule 65(3)(1)(h), Operational field alongside the statutory particulars, Optional operational fields. Each section contains specific fields that registered pharmacist / pharmacy licence holder must complete. The structured layout ensures nothing is missed during healthcare / pharmacy recordkeeping and makes the process efficient, typically taking 1-2 minutes per entry to complete.
Who should use this Schedule H1 Drug Register Format | Rule 65(3)(1)(h) [FREE PDF]?
This checklist is primarily designed for registered pharmacist / pharmacy licence holder working in healthcare / pharmacy operations. However, it is also valuable for quality assurance teams, safety officers, compliance managers, and supervisors who need to verify that healthcare / pharmacy standards are being met. Organizations of all sizes can benefit from using this Schedule H1 Drug Register Format | Rule 65(3)(1)(h) [FREE PDF] to maintain consistency and accountability.