Supply and distribution records in hospital pharmacy

Unique record

No, there is likely to be more than one copy.

Reason for keeping

Keep for reference.

Minimum period

Retain for 3 months.

Comment

Keep for a reasonable period and to reflect current practice.

Unique record

No, there is likely to be more than one copy.

Reason for keeping

Keep to demonstrate compliance with GXP and for audit purposes.

Minimum period

Retain for 2 years or 5 years.

Comment

Current financial year plus 1.

The 6-tax-years limit relates to disputes over simple contract (Limitation Act 1980). Manufacturers, and sometimes others involved in a product’s supply chain, are liable for their products under the Consumer Protection Act 1987. Therefore, it is recommended to keep delivery notes or invoices for 11 years as product liability records.

Wholesaler Dealers EU Guide on Good Distribution Practice requires retention of all records for 5 years.

Unique record

No, there is likely to be more than one copy.

Reason for keeping

Keep for reference.

Minimum period

Retain for 1 year.

Comment

This is a record of what was requested by ward pharmacist; unlikely benefit after 12 months.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 2 years.

Comment

Current financial year plus 1.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 18 months.

Comment

It should be noted that the original RMCoP 2016 document has been superseded by the 2021 version, which no longer includes the relevant information.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement and evidence against future claims.

Minimum period

Retain for 5 years.

Comment

Examples of documentation includes Certificates of Analysis (COA) and Certificates of Conformity (COC).

Records of the batch number should also be kept.

Provenance

• The supply of unlicensed medicinal products (“specials”). MHRA Guidance Note 14. 2014.
• The Human Medicines Regulations 2012 (regulation 170 (1))