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Posted by / 18-Oct-2018 09:34

Usp 797 standards beyond use dating

Compounding preparation monographs are generally used for specific patients who may need a certain strength or dosage form of a drug that is not commercially available, or may have an allergic reaction to an ingredient in the drug.

Compounded preparation monographs assist practitioners in compounding formulations in a consistent manner, in conformance with USP standards.

They did this through mixing, grinding, filtering, percolating, heating, and distilling, which led to preparations of vinegars, extracts, infusions, elixirs, syrups, tinctures, ointments, and pills.

The rise of manufactured medicines in the late 1800s and early 1900s decreased the need for compounded preparations on a large scale, but compounding continued to be part of the “art” of pharmacy, and addressed the specific needs of the patient.

Today, compounding has made a resurgence because of many drug shortages in recent years; the need for customized drug formulations as a result of allergies; special dosage forms for pediatric patients, geriatric patients, and special needs populations; and the movement toward specialty and personalized medicines.

The injections and infusions compounded in hospitals and other health systems include large-volume parenterals (LVPs) and small-volume parenterals (SVPs).” IV admixtures are those LVPs or SVPs to which injections have been added.

The Expert Committee members review and incorporate comments as appropriate.

A “Commentary” is published to explain the rationale of whether the comment was incorporated once a standard becomes official.

Sterile preparations typically include injections, infusions, and some irrigation, ophthalmic, and inhalation preparations. Food and Drug Administration (FDA) defines compounding as "...a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.” was in the process of being revised; following submission of thousands of comments on the initial draft, the United States Pharmacopeial Convention (USP) announced in January 2017 that it would republish the revised proposed general chapter for a second round of public comments.

Nonsterile preparations typically include oral suspensions, topical solutions, topical suspensions, topical gels, powders, ointments, creams, emulsions, suppositories, and others. The new revision will likely take several years to complete and thus is not the focus of this CE program.

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