Market Overview

Lipoderm® Topical Vehicle Used in USP Compounded Preparation Monograph

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The new USP Compounded Preparation Monograph for Ondansetron
Compounded Topical Gel (20 mg/ml) includes PCCA's proprietary topical
base as a key ingredient

Lipoderm® – developed and produced by PCCA, and the first proprietary
permeation enhancing vehicle in the compounding industry – is now
included in the official USP Compounded Preparation Monograph for Ondansetron
Compounded Topical Gel (20 mg/ml)
.

"The monograph represents a significant investment of time and resources
by the USP to create meaningful standards for compounding – and to
ensure that patients have access to the quality compounded medicine they
need," said Gus Bassani, PharmD, Vice President of Consulting, R&D and
Formulations for PCCA.

Published in the USP–NF and
in the USP
Compounding Compendium
, the monograph for Ondansetron Compounded
Topical Gel includes information such as: The formula, ingredients
(including PCCA's Lipoderm®), quantities of ingredients, directions on
how to correctly compound the preparation and the 90-day beyond-use date
(BUD), which is the date after which the preparation must not be used.
The BUD was determined by a study conducted by USP that utilized a
validated stability indicating methodology.

Since 1820, USP Compounded Preparation Monographs have provided quality
standards for specific preparations to assist practitioners in
compounding formulations for which there is no suitable commercially
available product for human and animal patients. As of July 2018, there
are nearly 200 official USP Compounded Preparation Monographs. After
identifying a public health need, USP initiates the creation of the data
and evidence necessary to create a Compounded Preparation Monograph. USP
has invested more than $1.8 million since 2012 in the development of
monographs to meet public health needs, as reported on its website (www.usp.org).

ABOUT LIPODERM®

Scientifically proven to deliver APIs through the skin, Lipoderm is the
ideal base in deep-penetrating topical formulations for local absorption
of APIs, as well as formulas for systemic absorption of APIs. It's
supported by an ever-growing portfolio of peer-reviewed journal
publications and FormulaPlus™ BUD-studied formulas. These FormulaPlus
BUD studies determine the physicochemical stability of a formula
utilizing a stability-indicating method. Lipoderm is also
non-comedogenic and doesn't separate with refrigeration,
resulting in cosmetically elegant and stable preparations of
deep-penetrating topical formulations. The patented Lipoderm core
technology has also led to the development of an entire line of
permeation enhancing bases. For more information about Lipoderm, contact
PCCA at 800.331.2498.

ABOUT PCCA

PCCA helps pharmacists and prescribers create personalized medicine that
makes a difference in patients' lives. As a complete resource for
independent compounding pharmacists, PCCA provides high-quality
products, education and support to more than 3,500 pharmacy members
throughout the United States, Canada, Australia and other countries
around the world. Incorporated in 1981 by a network of pharmacists, PCCA
has supported pharmacy compounding for more than 37 years. Learn more at www.pccarx.com.

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