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ASHP Guidelines for Selecting Pharmaceutical Manufacturers and Suppliers
Pharmacists are responsible for selecting, from hundreds of manufacturers and suppliers of drugs, those that will enable them to fulfill an important obligation: ensuring that patients receive pharmaceuticals and related supplies of the highest quality and at the lowest cost. These guidelines are offered as an aid to the pharmacist in achieving this goal.
Obligations of the Supplier
Pharmacists may purchase with confidence the products of those suppliers meeting the criteria presented here. Other factors such as credit policies, delivery times, and the breadth of a supplier’s product line also must be considered when selecting a supplier.
Technical Considerations
1. On request of the pharmacist, the supplier should furnish
a. Analytical control data.
b. Sterility testing data.
c. Bioavailability data.
d. Bioequivalency data.
e. Descriptions of testing procedures for raw materials and finished products.
f. Any other information that may be indicative of the quality of a given finished drug product.
Testing data developed by independent laboratories should be identified by the supplier. All information should be supplied at no charge.
2. There should be no history of recurring product recalls indicative of deficient quality control procedures.
3. The supplier should permit visits (during normal business hours) by the pharmacist to inspect its manufacturing and control procedures.
4. All drug products should conform to the requirements of The United States Pharmacopeia—The National Formulary (USP—NF) (the most recent edition) unless otherwise specified by the pharmacist. Items not recognized by USP—NF should meet the specifications set forth by the pharmacist.
5. To the extent possible, all products should be available in single unit or unit dose packages. These packages should conform to the “ASHP Technical Assistance Bulletin on Single Unit and Unit Dose Packages of Drugs.”1
6. The name and address of the manufacturer of the final dosage form and the packager or distributor should be present on the product labeling.
7. Expiration dates should be clearly indicated on the package label and, unless stability properties warrant otherwise, should occur in January or July.
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