Will Talk of California’s Pending Law
Fade into that of Federal Law?
The Safeguarding America’s
Pharmaceuticals Act of 2008, introduced in April 2008 as HR 5839 by
Representative Stephen Buyer (
RIN), would institute uniform national
standards that would supersede any
state-level requirements. “No state
or political subdivision of a state
may establish or continue in effect
any requirement with respect to
statements of distribution history,
manufacturer packing lists, unique
standardized numerical identifiers, or
drug identification and tracking systems for prescription drugs that is
different from, or in addition to, any
requirement under this subsection,”
the pending law reads. HR 5839
would amend Section 801(a) of the
Federal Food, Drug, and Cosmetic
Act ( 21 U.S.C. 381(a)).
Manufacturers and repackagers of
high-risk drugs would be required to
apply standardized unique identifiers
to each package from which the
product is repackaged or dispensed.
“Not later than 18 months after the
date of notice in the Federal Register
. . . each manufacturer or repackager
of a prescription drug that appears
on [a] list of high-risk drugs shall
apply a standardized numerical identifier that is unique to each unit
(namely, a package from which the
drug may be repackaged or dispensed) of the drug. The identifier
shall be applied by the manufacturer or repackager (in which case the
serialized number shall be linked to
the numerical identifiers applied by
the manufacturer),” it reads. Other
drugs shall be marked with standardized numerical identifiers
according to a timetable established
by the Health and Human Services
Secretary.
Standard pedigrees would consist
of “a statement, whether in paper or
electronic form, identifying each
wholesale distribution of such drug,
back to the authorized distributor of
record for such drug or a member of
the affiliated group.” If there is no
such authorized distributor of record,
the statement must trace back to the
manufacturer of such drug and
include the following:
• The proprietary and established
names of the drug.
• The drug's National Drug Code
number.
• Strength.
• Container size.
• Number of containers.
• The drug's lot or control number
or numbers.
• The business name and address
of all parties to each prior transaction involving the drug, starting with the authorized
distributor of record who provided the original statement of
distribution history required
under clause (i) or, if there is no
such authorized distributor of
record, back to the manufacturer of such drug.
• The date of each previous
transaction involving such drug,
back to the authorized distributor of record who provided the
original statement of distribution
history required under clause (i)
or, if there is no such authorized
distributor of record, back to the
manufacturer of such drug.
Standards would be developed
for “electronically accessible and
interoperable databases through
which drug manufacturers, repackagers, wholesale distributors, and
dispensers may authenticate the
wholesale distribution history of
prescription drugs using the numerical identifiers,” the act reads. Manufacturers or repackagers would be
required to employ numerical identifiers in at least one electronically
readable form.
The Healthcare Distribution Management Association (HDMA) supports HR 5839, Ron Bone, Senior
Vice President, Distribution Support,
for McKesson Corp., testified before
the House Energy and Commerce
Subcommittee on Health. “The bill
provides for a uniform, federal electronic pedigree standard that
the national supply chain can
implement. The variability of state
requirements creates a patchwork
of regulations that causes confusion, erodes efficiencies, and disrupts the just-in-time availability of
prescription medicines. These conflicting requirements slow the development and adoption of uniform
approaches to pedigree implementation.” He added that uniformity
would drive the development of
interoperable technologies to track
and trace pharmaceuticals across
the supply chain.
Pharmaceutical Research and
Manufacturers of America (PhRMA)
supports several anticounterfeiting
concepts in the act, testified Lori
Reilly, PhRMA vice president for
policy & research.
If passed, this proposed legislation will enable drug manufacturers
and trading partners to build a common infrastructure to meet a unified
set of requirements. Other standards must be put in place as well,
including electronic interoperability
and data carriers (RFID frequencies,
and 2-D codes), to further facilitate
investment for a cohesive system.
