Information chapters in pharmacopoeias.

Pharmacopoeias have been established by governmental authorities to serve three primary purposes: 1) to compile a select list of currently utilized drugs, including the most efficient forms for their application; 2) to distinguish these articles by convenient and definite names; and 3) to publish objective standards and analytical methods suitable for testing the integrity of commercially available preparations. In addition, some pharmacopoeias also offer informational text intended to instruct pharmacists on the compounding, use, storage and labeling of drugs; to advise physicians about dosage regimens and preferred modes of administration; to counsel producers about good manufacturing practices, and to edify drug analysts by explaining the theories underlying methods employed in compendial tests and assays. Examples of informational chapters in USP XIX are those on Pharmaceutical Dosage Forms, Stability Considerations in Dispensing Practice, and Sterilization. Because of the official status of national pharmacopoeias and their use as regulatory instruments in drug control, pharmacopoeial text intended merely for the information of the reader should be identified as such, and should be separated and distinguished from the mandatory, legally enforceable requirements.