34 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m
Once dosage form
development is initiated,
additional compendial
content becomes important.
Nomenclature used in pharmacopoeias for excipients,
drug substances, and drug products must also be consid-
ered during the product lifecycle. The link between a prod-
uct's generic name and the content of the active ingredient
can be important in clinical trials to support dosing studies,
in developing product strengths, and for filing and label-
ing purposes, especially in the United States. USP <1121>
states that USP–NF titles for monograph articles are legally
recognized under the FD&C Act as the designations for use
in labeling the articles to which they apply and relate to the
adulteration and misbranding provisions of the Act. USP
<1121> also contains a section on the monograph naming
policy for drug products containing salt drug substances.
The USP Salt Policy stipulates that USP will use the name of
the active moiety, which is the molecule or ion responsible
for the physiological or pharmacological action of the drug
substance, instead of the name of the salt, when creating
drug product monograph titles for such a drug product.
The policy also stipulates that USP will base the strength
of the product on the active moiety. Companies need to
be aware of the USP Salt Policy, which is enforced by FDA
(6, 7), to avoid issues with the name and strength listed
on drug product labeling and in registrations. The FDA
guidance (6) states that a drug product with labeling that
contains a name that is inconsistent with the applicable USP
monograph title risks being misbranded. Another example
of the impact of pharmacopoeia nomenclature is the tran-
sition from the excipient name hydroxypropyl methylcel-
lulose to the shortened title hypromellose, which resulted
in significant revisions to the ingredient listing on labels
and in registrations.
Once a product is launched and reaches the end of ex-
clusivity, compendial monographs for drug substances
and drug products will be developed by the pharmaco-
poeia. This is generally accomplished with the support
of companies who have received regulatory approval for
these products, to provide a public quality standard in the
pharmacopoeia that is applicable to the product or material
from all approved sources. Considerations for monograph
development, looking at the impact to both innovator and
generic-drug companies, will be provided in a later article
in this series.
Conclusion
In this article, the first in a series about compendial ac-
tivities in the bio/pharmaceutical industry, the basis for
pharmacopoeia compliance expectations was provided,
a long w it h consideration of how t he pharmacopoeias
impact drugs t hroughout t heir product lifecycle. The
increasingly global environment for industry, regulators,
and pharmacopoeias, where expectations and standards
do not always agree, represents one of the significant chal-
lenges to ensuring consistent and sustained compendial
compliance.
Subsequent articles in this series will cover a wide range
of topics: providing information to help in the creation of an
effective compendial review process; presenting a case study
in compliance for excipients and raw materials; discussing
considerations for monograph development; giving recom-
mendations concerning global vs. national pharmacopoeias
and the need for harmonization in order to establish con-
sistent, global pharmacopoeia standards, which will help
industry deliver medicines with consistent quality to extend
and improve the lives of patients around the world while
meeting health authority expectations. It is the authors' goal
for these articles to provide clear understanding about the
need for pharmacopoeia compliance and practical guidance
to assist those who perform this work to establish effective
processes, partnerships and tools to maintain appropriate
and timely compliance across the bio/pharmaceutical in-
dustry to the benefit of patients.
Acknowledgment
The authors gratefully acknowledge the contribution of
Susan J. Schniepp for her technical review and helpful sug-
gestions during the preparation of this series of articles.
References
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