K&LNG
DECEMBER 2006
Alert
Food & Drug Practice
FDA Drug Establishment Registration and
Drug Product Listing Changes on the Horizon
K&LNG Attorneys Will Attend 12/11/06 FDA Meeting on NDC System
The Food and Drug Administration (“FDA”)
announced a public meeting, scheduled for December
11, 2006, to discuss proposed changes to the National
Drug Code (“NDC”) system. The meeting is related
to an FDA proposed rule to establish new rules and
requirements for the registration of foreign and
domestic drug establishments and the listings of
human drugs. The proposed rule would significantly
alter the NDC system; specifically, the process by
which NDC numbers are generated and recorded for
manufacturers, repackers and private label
distributors. The public meeting will present an
opportunity for the public and FDA to discuss the
NDC-related issues raised by the proposed rule. See
71 Fed. Reg. 63,726 (October 31, 2006), available at
http://www.fda.gov/OHRMS/DOCKETS/98fr/E618310.pdf (Meeting Announcement); 71 Fed. Reg.
51,275 (August 29, 2006), available at
http://www.fda.gov/OHRMS/DOCKETS/98fr/067172.pdf (Proposed Rule).
SUMMARY
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As a service to our clients, we will be sending
one of our attorneys to this public meeting
and preparing a written summary of the
meeting. If you would like to receive a copy
of the summary for a set fee of $300, please
contact one of the attorneys listed at the
bottom of this Client Alert.
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So that you can better understand the potential impact
of the Proposed Rule on your company, we briefly
summarize several regulatory changes under
consideration, as well as some issues raised by the
Proposed Rule.
The NDC number is comprised of three parts:
the labeler code, the product code, and the
package code. Currently, FDA assigns the
labeler code to the company, and the company
assigns the product and package code to each
drug product to complete the NDC number.
Under the Proposed Rule, FDA will assign all
parts of the NDC number (labeler code,
product code, and package code), thereby
reducing each company’s flexibility in creating
its own NDC numbers.
Currently, the listing of NDC numbers on drug
labels is voluntary. Under the Proposed Rule,
NDC numbers will be required on all drug
labels and any outside container of the retail
package.
Currently, for most drugs, the company can
choose whose NDC number to list on the drug
product label (e.g., the drug manufacturer’s
NDC number, the repacker’s NDC number, or
the private label distributor’s NDC number).
The Proposed Rule would require the drug
label to bear the NDC number of the party last
responsible for the drug immediately before
the drug is received by the wholesaler or
retailer.
Currently, a private label distributor (“PLD”)
can obtain a company labeler code and submit
listing forms for its drug products on its own.
Under the Proposed Rule, PLDs will no longer
be able to submit registration and listing
information. Instead, manufacturers,
Kirkpatrick & Lockhart Nicholson Graham LLP |
DECEMBER 2006
repackers, relabelers, and drug product
salvagers will be responsible for obtaining the
labeler code and remaining NDC components
on behalf of their PLDs.
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If a drug already has an NDC number at the
time of the effective date of a final rule, the
drug will retain that NDC number provided
that the manufacturer, repacker, or relabeler,
within 9 months after the effective date of a
final rule, reviews and updates the information
in FDA’s database for the NDC number.
However, if there is any change to an existing
product, FDA will generate a new NDC
number for the product.
Currently, drug establishment registration and
drug product listing is accomplished through a
paper submission format. Under the Proposed
Rule, all establishment registrations and drug
listings will be submitted electronically. Drug
listing will be a two-step process. First, the
lister will be required to submit information to
obtain an NDC code. After receiving an NDC
code, the lister will submit the required drug
product listing information.
Initial and updated registration and listing will
be largely conducted electronically. FDA will
make all registration information and most
listing information publicly available.
ISSUES
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The Proposed Rule will place additional
responsibilities on the manufacturer, repacker,
or relabeler in connection with PLD labeler
code and drug product listing functions.
A PLD may have multiple contract
manufacturers. The Proposed Rule does not
address whether this will result in multiple
labeler codes for the same private label
distributor and/or multiple NDC numbers for
the same product.
The two-step listing process may slow down
the entry of certain drug products to the
market. The Proposed Rule contains no FDAprocessing time provisions to assure efficient
assignment of NDC numbers once companies
submit the required information.
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Liability issues associated with the listing of
NDC numbers on drug product labels are
likely. If a manufacturer, repacker, or relabeler
places the wrong NDC number on the product,
the liable party responsible for corrective
action will have to be identified.
FDA’s electronic registry of NDC numbers,
labeler codes, product codes, and packaging
codes may make available to the public
business relationship information generally
deemed confidential.
The proposed Rule may conflict with certain
state laws. A few State Pharmacy Boards
require that prescription drug labels and
labeling bear the name of the actual
manufacturer or NDA holder, rather than the
repacker or PLD. FDA’s prior policy has been
that this identification decision is up to the
marketer, but that the NDC number on the
package should match the identified company.
Since the Proposed Rule requires the NDC
number to belong to the “last party
responsible”, this may affect the product’s
manufacturer signature line for PLDs or
repackers who seek compliance with certain
state laws. In other words, a federally-required
signature line of “Distributed by PLD” with
PLD’s NDC number would be inconsistent
with states that require “Manufactured by
Actual Manufacturer” and Manufacturer’s
NDC number.
The Proposed Rule is detailed and complex. The
impact on the pharmaceutical industry remains under
consideration. As a result, FDA has agreed to extend
the written comment period to January 26, 2007.
Ann M. Begley
202.778.9365
abegley@klng.com
Grace Hsieh
202.778.9117
ghsieh@klng.com
FDA-generated new product/package codes
may disrupt individual companies’ internal
tracking systems.
Kirkpatrick & Lockhart Nicholson Graham
LLP
|
DECEMBER 2006
FOR MORE INFORMATION, please contact one of the lawyers listed below.
PARTNERS
Ann M. Begley
Bob Hibbert
Suzan Onel
Gary L. Yingling
202.778.9365
202.778.9315
202.778.9134
202.778.9124
abegley@klng.com
rhibbert@klng.com
sonel@klng.com
gyingling@klng.com
OF COUNSEL
Rebecca L. Dandeker
Emalee G. Murphy
202.778.9409
202.778.9428
rdandeker@klng.com
emalee.murphy@klng.com
ASSOCIATES
Grace Hsieh
Karl Nobert
Anthony T. Pavel
202.778.9117
202.778.9460
202.778.9412
ghsieh@klng.com
knobert@klng.com
apavel@klng.com
www.klng.com
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