36 RXINSIDER | 2026 PHARMACY500 PLATINUM PAGES
COMPOUNDING
• Closed System Drug-Transfer Devices (CSTDs)
• Sterile Compounding Automation, IV Automation
• USP <795> Non-Sterile Resources, Compliance, Technology
• USP <797> Sterile Resources, Compliance, Technology
• USP <800> Resources, Compliance, Technology
OVERVIEW
Pharmacy compounding involves preparing customized
medications to meet individual patient needs, governed by strict
regulatory standards such as USP <795>, <797>, and <800>.
Non-sterile compounding creates formulations like creams or
capsules in clean environments, while sterile compounding,
essential for injectable and high-risk medications, requires
aseptic conditions to prevent contamination.
KEY TERMS
• Pharmacy Closed System Drug-Transfer Devices (CSTDs)
are specialized mechanical devices designed to prevent the
escape of hazardous drug vapors, aerosols, and liquids during
drug preparation, transfer, and administration, ensuring a
safer working environment and minimizing risks associated
with the handling of hazardous drugs.
• Pharmacy sterile compounding automation refers to the
use of advanced mechanical systems to prepare sterile
compounded medications in a controlled and precise manner,
under aseptic conditions, ultimately reducing the risk of
contamination and human error.
• Non-sterile pharmacy compounding (USP <795>) refers
to the process of preparing customized medications in a
pharmacy setting under conditions that do not require a
sterile environment. This practice involves mixing, combining,
altering, or assembling pharmaceutical ingredients to meet
the specific needs of an individual patient when commercially
available medications are not suitable. The primary focus of
non-sterile compounding is to ensure that the compounded
medication is safe, effective, and tailored to the patient’s
requirements while adhering to established quality control
practices.
• Sterile pharmacy compounding (USP <797>) refers to
the preparation of customized medications in a controlled
environment that meets stringent sterility requirements to
prevent contamination. This process is typically used to
prepare medications intended for administration by injection,
infusion, or other routes requiring sterility, such as ophthalmic
or intrathecal delivery.
• Hazardous pharmacy compounding (USP <800>) refers to
the standards established by the United States Pharmacopeia
(USP) to ensure the safe handling of hazardous drugs (HDs) in
healthcare settings, including pharmacies, to protect personnel,
patients, and the environment from exposure to hazardous drugs
during receipt, storage, preparation, transport, administration,
and disposal.
Source: Alliance for Pharmacy Compounding
of compounding pharmacies
employ 12 individuals or fewer.
61%
of compounding pharmacies
compounded drugs listed
in shortage in the previous
12-month period.
57%