Manufacturing Versus Compounding:
Basic Differences
Manufacturing and compounding are two very different
practices that are regulated differently as well. Ohio recognizes and
enforces federal law that states compounding
is performed by a pharmacist in a pharmacy and pursuant to a
patient-specific prescription (refer to 21 USCA
353a). Manufacturing does not require a patient-specific
prescription, but requires a manufacturing license from
FDA that enables the company to produce and sell manufactured medications
(typically in bulk) again without a
patient-specific prescription. To obtain an FDA manufacturing license,
the manufacturing site must also pass
stringent quality assurance standards (good manufacturing practice)
designed to test manufacturing of sterile
drug product. Thus, there is much more scrutiny placed
on this type of practice (manufacturing) typically due to
the large amounts of drug product being made for resale.
Medication compounding, on the other hand, involves
the practice of taking commercially available products
and modifying them to meet the unique needs of an individual
patient pursuant to a prescription from a licensed
provider. Our state law defines compounding in Ohio
Revised Code 4729.01(C). Also, a pharmacy must follow
the compounding requirements pursuant to Ohio Administrative Code
(OAC) Rules 4729-5-25, 4729-9-25, 4729-
9-21, and 4729-19; current professional compounding
standards; and all applicable federal and state laws, rules,
and regulations. As required by OAC 4729-19-04, for
compounding sterile injectables, the Board would expect
to see in your written policies and procedures adherence
to United States Pharmacopeia (USP) Chapter 797 guidelines.
These guidelines are differentiated by the severity/
risk of the type of products being compounded. The Board
expects that you review and understand these guidelines
to assess your practice prior to compounding sterile injectable
prescriptions. For more information regarding
the USP Chapter 797 compounding guidelines, visit www
.usp.org/store/products-services/usp-compounding.
Compounding in Ohio does not require a special FDA
manufacturing license and can be performed with no
extra licenses other than those required by the Board
for pharmacy practice (RPh license for the pharmacist
to practice, a terminal distributor of dangerous drugs
license for the location, and, if needed, a Drug Enforcement
Administration license for controlled substances).
No doubt, compounding is a legal and common practice
in many Ohio pharmacies and brings incredible value to
Ohio patients. However, make sure that your processes
meet all standards for compounding and that you are not
manufacturing as defined above. The Board has created
a great compounding document for review, which can be
accessed from the Board’s Web site at www.pharmacy
.ohio.gov. Click on the “Terminal Distributor (TDDD) Licenses”
tab and then on the “Compounding in Ohio” link.
Source found here
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