Records and Registers to be Kept in a Pharmacy under the control of the pharmacist.

Provisions in the Drugs and Cosmetics Act 1945. Subject Pharmacy Law and Ethics.

Records to be kept in a pharmacy

The Drugs and Cosmetics Rules, 1945, state guidelines for maintaining records in a pharmacy to ensure compliance with the law. The following are some general points related to record-keeping in a pharmacy under the Drugs and Cosmetics Rules, 1945:

Prescription Record

• 1. The supply of any drug other than those specified in Schedule X on a prescription of a Registered Medical Practitioner shall be recorded in a prescription register. The serial number of the entry in the register shall be entered on the prescription. The following particulars shall be entered in the register:

  • serial number of the entry,

  • the date of supply,

  • the name and address of the prescriber,

  • the name and address of the patient, or the name and address of the owner of the animal if the drug supplied is for veterinary use

  • the name of the drug or preparation and the quantity,

  • in the case of a drug specified in Schedule C or Schedule H and Schedule H1 the name of the manufacturer of the drug, its batch number, and the date of expiry,

  • the signature of the registered Pharmacist

• 2. OR All above information 1 to 8 shall be entered in serially numbered cash/credit memos especially meant for this purpose.

• 3. Only entry of a serial number, the date of supply, and the quantity supplied in the register during the refilling of the prescription.

• 4. It is not necessary to record all details in the register or cash/credit memo if the drug is supplied against

  • · Prescription under the Employees State Insurance Scheme if all particulars are written on the prescription,

  • · Any drug other than that specified in Schedule C or Schedule H and Schedule H1, if it is supplied in the original unopened container of the manufacturer and if the prescription is duly stamped at the time of supply with the name of the supplier and the date on which the supply was made.

• 5. The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply. The information recorded is the name and address of the prescriber, the name of the patient, the name of the drug, and the quantity supplied. Records shall be maintained for three years and be open for inspection.

• 6. The option to maintain a prescription register or a cash/credit memo book shall be informed in writing to the Licensing Authority at the time of application for the grant or renewal of the license.

• 7. The Licensing Authority may require records to be maintained only in the prescription register if the entries in the carbon copy of the cash/credit memo book are not legible.

Sale Record

• 8. The supply by retail of any drug shall be made against a cash/credit memo which shall contain the following particulars:

  • · Name, address, and sale license number of the dealer,

  • · Serial number of the cash/credit memo,

  • · The name and quantity of the drug supplied.

  • · Carbon copies of cash/credit memos shall be maintained by the licensee as a record.

• 9. The Whole Seller supplies drugs and maintains a cash or credit memo bearing the name and address of the Whole Seller and his license number under the Drugs and Cosmetics Act. The following particulars shall be entered

  • · the date of sale,

  • · The name, address of the retailer, and his sale license number.

  • · In case of sale to an authority on behalf of the Government, to a hospital, medical, educational, or research institution, or to a Registered Medical Practitioner

    • § The name of the drug,

    • § the quantity and

    • § The batch number,

    • § The name of the manufacturer,

  • · The signature of the competent person.

• 10. Carbon copies of cash or credit memos shall be preserved as records for three years from the date of the sale of the drug.

Purchase Record

• 11. Records of purchase of a drug intended for sale or sold by retail shall be maintained by the licensee. Records shall show the following particulars:

  • · The date of purchase,

  • · The name and address of the person from whom purchased and the number of the relevant license held by him,

  • · The name of the drug, the quantity and the batch number, and

  • · The name of the manufacturer of the drug.

  • · Purchase bills including cash/credit memos shall be serially numbered by the licensee and maintained by him in chronological order.

• 12. Records of the purchase of a drug intended for resale shall be maintained by the licensee. Records shall show the following particulars, namely:

  • the date of purchase

  •  the name, address, and number of the relevant license held by the person from whom purchased,

  • the name of the drug, the quantity and the batch number, and

  • the name of the manufacturer of the drug.

  • Purchase bills including cash or credit memos shall be serially numbered by the licensee.

Duration of Records

• 13. All registers and records maintained shall be preserved for not less than two years from the date of the last entry. Except duration specified for specific registers and records.

• 14. Two copies of prescriptions from registered medical Practitioners shall be required for substances specified in Schedule X. One copy of the prescription shall be retained by the licensee for two years.

Prescription details

A prescription shall be in writing and be signed with a date by the registered medical practitioner. Prescriber shall specify 

• the name and address of the patient, or the name and address of the owner of the animal if the drug is meant for veterinary use.

• indicate the total amount of the medicine to be supplied and the dose to be taken.

Alok Bains