Title: APHIS Mand: lion and Sale Procedures

Release Date: 20 May 2021 Document Number: CVB-WI-0073.02

USDA
a7

Animal and Plant

Health Inspection APHIS Mandated Stop Distribution and Sale Procedures

Service

CONTROLLED//PROPIN//BASIC

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(515) 337-6100

Document Number: CVB-WI-0073 Revision: 02
Previous Number: ICWI0033.02

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 20 May 2021

Notes:

HR «24 May 2021, 09:26:20 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: APHIS Mandated Stop Distribution and Sale Procedures
Release Date: 20 May 2021 Document Number: CVB-WI-0073.02
CONTROLLED//PROPIN//BASIC

APHIS Mandated Stop Distribution and Sale Procedures
Source Document: 9 CFR 105.3, Revised January 1, 2009

1. CVB-IC concurrence

a) Review 9 CFR 105.3. Notices re: worthless, contaminated, dangerous or harmful
biological products

5) Review VS Memorandum 800.53: Action to stop distribution and sale of product
may be necessary to prevent risk to the health of animals, to the public health or
well-being, or to the environment.

e Note that 9 CFR105.3 (c)(2) requires notification to go to all persons
known to have received the product. We execute regulatory flexibility
based on the risk; not all notifications are required to go to the end person.

c) Bring the issue to an IC Section Leader and evaluate the risk in relationship to the
Virus-Serum-Toxin Act. For example,

e Is the product worthless?

o Potency test unsatisfactory?
e Is the product contaminated?
o Organic?
o Inorganic?
e Is the product dangerous?
o Safety issues?
o Diagnosis incorrect?
e Is the product harmful?
co To the public interest?
o Diagnosis may create economic harm?

d) If future serials/subserials of a Product Code are in jeopardy, holds may be needed
to be placed on the Product Code(s).

e) Once agreement has been reached, as quickly as possible, schedule a time to
contact the primary liaison of the firm for notification of the action.

f) Ifprimary liaison is not available; the alternate liaison can be notified. If
alternate(s) liaison is not available check the APHIS Form 2001/2005 (on file)
and you may notify a Principle Officer.

g) Be prepared to describe why CVB is taking the action and why to the level
determined. Determine if there is any needed documentation of (firm’s)
notification needed from the firm.

2. Notification to firm of APHIS Mandated Stop Distribution and Sale

a) AnIC Section Leader or Acting must be present during the telephone
conversation of the notification. See CVB-SOP-0024, Delegation of Authority for
Center for Veterinary Biologics-Inspection and Compliance, for delegation of
authority questions.

b) Documentation of the telephone conversation is required.

c) Notify liaison of the APHIS Mandated Stop Distribution and Sale. Be specific to
Product Codes and/or Serials/Subserials.

d) Notify liaison of the level of the action.

CVB-WI-0073.02 Page | of 2

jon 24 May 2021, 09:26:20 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: APHIS Mandated Sto tribution and Sale Procedures.
Release Date: 20 May 2021 Document Number: CVB-WI-0073.02
CONTROLLED//PROPIN//BASIC

Licensed premises

Licensed distributors

All distributors known to have received the product

e All persons known to have received the product

e) Dependent upon circumstances, firm may be directed to account for the remaining
quantity of each serial/subserial at each location (or specific location) in the
distribution channel (9 CFR 105.3 (c)(3)).

f) You may require the liaison to submit a complete and accurate report of all
notifications concerning the stop distribution and sale action (9 CFR 105.3 (c)(4)).

3. Confirmation of Notification
a) Confirm conversation by letter to primary liaison, the same day or next business
day or as soon as possible depending on resources. Utilize template letter.
b) See CVB-SOP-0037, Investigation and Processing of Alleged Violations of the
Virus-Serum-Toxin Act, if an investigation is involved.

CVB-WI-0073.02 Page 2 of 2

 camrsussxeacast 24 May 2021, 09:26:20 am.
Controlled by: nter for Veterinary Biologics, 515-337-6100