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CODE OF GOOD PHARMACEUTICAL WHOLESALE DISTRIBUTION PRACTICE.

INTRODUCTION

Medical products before they are made available for use by the medical profession for treatment are subjected to long and expensive processes of research, development and licensing to ensure safety and efficacy.

Pharmaceutical wholesale distributors form part of the supply chain from pharmaceutical products and they are responsible for the effective and efficient handling, storing and distributing of such products in order that they reach the patient promptly on demand, and in perfect condition.

This Code of Practice has been sponsored by the British Association of Pharmaceutical Wholesalers. All member Companies have agreed to maintain these as the minimum standards of storage and distribution.

STORAGE AND DISTRIBUTION

a. Wholesalers must carry a comprehensive stock of prescription products and over the counter medicines for which there is a demand even if such demand is irregular, and also sufficient depth of stock to ensure continuity of supply to the customer from shelf stock.
b. The wholesaler will hold a current Wholesale Dealers’ Licence issued by the Medicines Control Agency and the necessary Controlled Drug, Industrial Methylated Spirit and Alcohol licences.
c. Key personnel involved in the warehousing of medicinal products should be suitably trained and have the ability and experience appropriate to the responsibility of ensuring that the products or materials are properly handled, stored and distributed.
d. Stocks should be received in a separate reception area, and examined for correctness against order, and for absence or damaged containers. There should be a system for the recognition and prompt handling of Controlled Drugs and those products requiring specific temperature storage. Where appropriate there must be a system for batch recording of LVP’s of 500 mls and over.
e. All medicinal products handled by the distributor must have a UK Product Licence or Parallel Import Licence. All products must be stored under acceptable conditions, which take account of any requirements specified by the manufacturer. Stock, which is known to have a risk of contamination, should be stored in conditions, which prevent such an occurrence.
f. All products should be protected from excessive local heating, and from undue exposure to direct sunlight, and (unless they are known to be unaffected) from freezing.
g. Sufficient provisions should be made to ensure that temperature storage conditions specified by the manufacturers are adhered to.
h. Temperature controlled storage areas should be equipped with temperature recorders which will indicate that the specified temperature range has been maintained. Control should be adequate to maintain all parts of the storage area within the specified range.
i. There should be system to ensure stock rotation, with regular and frequent checks that the system is operating correctly. Products approaching their expiry date or shelf life should be removed from useable stock and neither be sold nor supplied.
j. Stock which is damaged or withheld from supply, and which is not immediately destroyed, should be kept apart from saleable stock, so that it cannot be sold in error, and so that leakage from any broken package cannot contaminate other goods.
k. Stocks of sterile products with broken seals, damaged packaging, or suspected of possible contamination must not be sold nor supplied.
l. Products should be transported in such a way that:
   1) the identification of the product is not lost;
   2) the product does not contaminate, and is not contaminated by, other products or materials;
   3) adequate precautions are taken against spillage or breakage; and
   4) the product and its pack are not subjected to unacceptable degrees of heat, cold, light, moisture or other adverse influence nor to attack by microorganisms or pests.
m.     Goods which have been rejected, recalled or returned should be placed in segregated storage to avoid confusion with other materials and products and to prevent redistribution, until instructions have been issued as to their disposal.    

RETURNED GOODS

Goods which have left the care of the wholesale dealer should only be returned to saleable stock if:

a. they are in their original unopened containers and in good condition and bear a valid product licence number;
b. it is not suspected that they have been subject to adverse conditions; and
c. they have been examined and assessed by a person authorised to do so, which assessment should take into account the nature of the product, and special storage conditions it requires, and the elapsed time since it was issued. If necessary, advice should be sought from the person responsible for the Quality Control of the manufactured product.


RECALL

a. An emergency recall plan should be available in writing. The "Responsible Person" is responsible for the plan’s execution. In the case of a Wholesaler with more than one warehouse one of their "Responsible Persons" should be nominated to co-ordinate the recall.
b. Urgent Recall
   1) The Manufacturer, the Department of Health, or other competent authority can order a product recall. They will inform all Wholesalers and other suppliers of this decision giving the name of the product, batch number, pack size, and any other relevant information.
   2) Wholesalers are to immediately inform all their customers including those in other Member States. This can be done by on line computer, telephone or by other suitable means. It is important that this recall notice is not limited only to customers to whom the product has been supplied. It is accepted that customers with more than one Wholesaler will receive the recall notice from more than one source.
   3) The recall should request the customer to isolate the product immediately and if necessary to contact the patient. The Wholesaler will then collect the isolated product and together with his own isolated stock await disposal instructions from the Manufacturer.
c. Routine Recall

Recall of a product where the urgency is less than immediate should follow the same procedure except that the time-scale for action will be longer and appropriate to the need.
     
     


RECORDS

Clear, readily available records of each sale should be made; showing date of supply, customer, product name and quantity. They should be retained for the statutory period in force for the product concerned.

TRANSPORTATION

The Wholesaler will offer a regular prompt delivery service to all customers. The frequency of the delivery and lead-time will depend upon the nature of the product and the urgency with which it is required.


TRAINING & SUPERVISION

a. All personnel involved in the warehousing and distribution of medicinal products should be suitably trained and have the ability and experience appropriate to their responsibility.
b. Wholesalers will nominate a person at each warehouse to be responsible for ensuring that this Code is complied with and its focal point in that company location for all aspects of the Wholesale Dealers’ Licence. This person will be a senior manager, suitably trained and experienced, who will be known as the ‘Responsible Person’ and his appointment and telephone number will be registered with the Association.
c. Wholesalers are to have ready and regular access to a registered pharmacist for specialist advice. Such a person could be an owner, a director, employee or a retained consultant.

Updated: 27-Apr-00

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