Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
- Laboratory Waste Management, Types and Its Disposal - January 28, 2024
- How to Become a Skilled Manufacturing Chemist in the Pharma Industry - January 26, 2024
- Sweet Science: Exploring Importance of Inverted Sugar in Pharma Industry - December 5, 2023
Last Updated on May 13, 2024 by The Health Master
Record keeping for Medical Store / Pharmacy
Record keeping for Medical Store / Pharmacy
Abbreviations:
The Act: Drugs and Cosmetics Act 1940, and Rules Framed Thereunder
RSDL: Retail Sale Drug License
WSDL: Whole Sale Drug License
RP: Registered Pharmacist
EP: Experience Person
NSQ: not of std. quality
CS: Civil Surgeon
TB: Tuberculosis
DCO: Drugs Control Officer
All medical stores/pharmacies (retailers/wholesalers) have to maintain the various records as per the Drugs and Cosmetics Act 1940, and the Rules framed thereunder.
Here is a list of records/documents all the medical stores/pharmacies (retailers or wholesalers) have to maintain on the premises.
They have to produce the said records/documents before the notified Inspector when asked:
- Drug file: Maintain a drug file Keep all the correspondence in the drug file. Correspondence with drug authorities. License retention fee record Records of any change in constitution or change in premises, if any. Inspections records
- Correspondence file: Maintain a correspondence file and keep all correspondence with dealers in this file.
- Drug license: Keep copies of all the documents submitted during the grant of the license. Keep a copy of the retail drug licenses / wholesale drug licenses in the file.
- Inspection record: Keep copies of all inspections done by the Drug Control Officer in your area.
- Registered Pharmacist (RP): Keep copies of all the documents of the Registered pharmacist, i.e., registration certificate, qualification certificates, and address proof.
- Change of Registered Pharmacist (RP): Keep copies of all the documents regarding the change of RP. Application to Drug Department with the details and dates of relieving the previous RP and joining the new RP, Copy of Regn. Certificate, Qualification Certificates; Address Proof.
- Refrigerator: Purchase invoice of the refrigerator
- Purchase records of drugs: Maintain purchase files and keep all the purchase invoices of drugs in chronological order. Keep payment records for drugs. Keep a transportation record for drugs.
- Sale records of drugs: Maintain sale records of drugs by means of an invoice book having all the details as per the Act. The sale of scheduled drugs must be under the personal supervision of a registered pharmacist. Maintain sales records in a legible manner.
- Schedule-H1 register: Maintain schedule-H1 register for Schedule-H1 drugs
- TB Drugs Record: Keep all the sales records of the TB drugs, as per the directions of the drug department. or health authorities. i.e., details of the patients and details of the drugs given. Send the required details to the authorities from time to time.
- NDPS Drugs Record: Keep all the sales records of the NDPS drugs, as per the directions of the drug department.
- Expiry drugs: Keep a record of expired drugs, i.e., correspondence with the dealer about returning the expired drugs.
- Returned drugs: Keep a record of drugs returned, i.e., correspondence with the dealer for returning the expired drugs.
- Suspension of licenses: Keep records of suspensions of licenses, if any.
- NSQ drug: Keep records of NSQ drugs (sampled from the medical store and declared by the Government Analyst), if any.
Note:
- Always stock the drugs properly on racks and avoid direct sunlight.
- Always purchase the drugs with an invoice from licensed dealers.
- Don’t stock and sell physician samples.
- Don’t stock and sell hospital-supply drugs.
- Don’t misuse intoxicating drugs.
How to obtain retail drug license
How to obtain Jan Aushadhi License
How to change pharmacist at medical store
Good storage practice of medicines at Medical Store
Record keeping for Medical Store / Pharmacy
Self inspection of Medical Store :105 points
Duties of Retail Chemists / Medical Store / Pharmacy
FAQs – on Medical Store / Pharmacy (Retail sale or Wholesale)
Difference between Sanitizer and Disinfectant
FAQs on Sanitizer, N95 Mask & Digital Thermometer
Also watch the Videos:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
