An Equal Opportunity Provider and Employer

VETERINARY SERVICES MEMORANDUM NO. 800.57

 

TO: Veterinary Services Leadership Team 

Directors, Center for Veterinary Biologics 

Biologics Licensees, Permittees, and Applicants

FROM: Jack A. Shere

Deputy Administrator

SUBJECT: Market Suspensions and Post Marketing Temperature Deviations

I. PURPOSE 

This memorandum provides guidance to licensees and permittees for actions to take 

concerning the stop distribution and sale of serials and subserials released to the 

market by the Center for Veterinary Biologics (CVB). The authority to suspend or 

revoke a product is described in title 9, Code of Federal Regulations (9 CFR), parts 

105.1 and 105.3. This memorandum also includes the notification process as 

required by 9 CFR, parts 105.3, 115.2, 116.5(b), and guidance concerning post 

marketing authorization temperature deviations. 

II. CANCELLATION

This memorandum replaces Veterinary Services (VS) Memorandum No. 800.57 

dated October 5, 2016. 

III. BACKGROUND

Animal and Plant Health Inspection Service (APHIS) may be required to informally 

suspend a product, a portion thereof, or a product line for various reasons. Evidence 

may emerge indicating that a licensed veterinary biological product, a portion 

thereof, or a product line may be worthless, contaminated, dangerous, or harmful. 

In the case of willfulness or where the public health, interest, or safety so require, a 

product, a portion thereof, or a product line may be informally suspended. Evidence 

may come from inspection findings, investigations, adverse event reports, or tests 

conducted by the licensee or permittee or the CVB.

Veterinary biological product released for marketing not prepared according to the 

procedures in the filed Outline of Production or the regulations may be worthless, 

contaminated, dangerous, or harmful. APHIS considers both human and animal 

interests in determining whether a product is harmful. Licensees or permittees that 

have not sufficiently investigated manufacturing deviations according to VS 

Memorandum No. 800.210 before marketing release may be subject to an APHISmandated stop distribution and sale action. APHIS may also subject the licensee or 

permittee to other regulatory action. 

Animal and Plant

Health Inspection

Service

Veterinary Services

1400 Independence

Ave., SW

Washington, DC

20250

for
VETERINARY SERVICES MEMORANDUM NO. 800.57

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APHIS may need to stop distribution and sale of a product to safeguard animal health, or 

to protect the public health, interest, or environment. The level of the action to stop 

distribution and sale will depend on the actual or potential harm caused by the use of the 

product. When APHIS notifies the licensee or permittee of an APHIS-mandated stop 

distribution and sale, CVB-Inspection and Compliance (CVB-IC) personnel will

communicate the resulting actions to the licensee or permittee.

IV. POLICY

A. APHIS Notification to Stop Distribution and Sale

1. The CVB-IC notifies the licensee or permittee of the specific affected product 

or products.

2. The CVB-IC communicates the level of the stop distribution and sale. The 

levels include all known users, distributors, or licensed or permitted premises.

3. When notified to stop distribution and sale, the licensee or permittee shall:

a. Stop the preparation, distribution, sale, barter, exchange, shipment, or 

importation of the affected serials, subserials, or portions of any affected 

veterinary biological products to the level the CVB-IC specifies. The 

licensee or permittee must also quarantine the affected biological products 

pending disposition instructions from the CVB-IC.

b. As instructed by the CVB-IC, immediately, but no later than 3 business 

days, send stop distribution and sale notifications to any wholesalers, 

jobbers, dealers, foreign consignees, or other persons known to possess the 

veterinary biological product. The licensee or permittee must instruct 

recipients to stop the preparation, distribution, sale, barter, exchange, 

shipment, or importation of any such veterinary biological product. The 

CVB-IC must review notifications prior to distribution. The licensee or 

permittee shall document all notifications.

i. If the CVB-IC certifies a Form 2017, 2046, or 2047 for export 

purposes for a serial, a portion of a serial, or subserial, and 

subsequently found the product unsatisfactory, the licensee or 

permittee will notify the importing country’s regulatory authority. The 

notification will inform the regulatory authority that APHIS has found 

the product unacceptable for marketing in the United States. 

ii. The licensee or permittee shall document all notifications.
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c. As instructed by the CVB-IC, account for and report the remaining 

quantity of each serial or subserial of any such veterinary biological 

product at each location in the known distribution channel, pursuant to 9 

CFR 116.2.

d. As instructed by the CVB-IC, submit complete and accurate reports of all 

notifications concerning stop distribution and sale actions to APHIS,

pursuant to 9 CFR 116.5.

B. Notification by the Licensee and Permittee of a Voluntary Stop Distribution and

Sale

1. If at any time indications raise questions regarding purity, safety, potency, or 

efficacy of a product, or if it appears there may be a problem regarding the 

preparation, testing, or distribution (domestic or international) of a product or 

a portion of a product, the licensee, permittee, or foreign manufacturer shall 

immediately notify the CVB-IC according to 9 CFR 116.5(b). 

a. The licensee, permittee, or foreign manufacturer must notify the CVB-IC 

if the CVB released the biological product for marketing.

b. The licensee, permittee, or foreign manufacturer must notify the CVB-IC 

if the CVB has not released the biological product for marketing but the 

licensee, permittee, or foreign manufacturer submitted an APHIS Form 

2008 in accordance with 9 CFR 116.7.

2. Product, other than product with a rabies claim, that deviates from 

temperature requirements post marketing authorization is exempt from 

notification if the licensee or permittee sufficiently investigates the effect on 

the product. Refer to VS Memorandum No. 800.210 concerning product 

manufacturing deviation investigations. If the investigation indicates that any 

deviations affected the product quality or shelf life, the licensee, permittee, or 

foreign manufacturer shall immediately notify the CVB-IC according to the 

regulations. The licensee or permittee must report temperature deviations of 

product with a rabies claim to the CVB.

3. If the CVB releases the biological product for marketing and the licensee or 

permittee stops marketing the product under the conditions described in 

9 CFR 116.5(b), the CVB will consider this a reportable Voluntary Stop 

Distribution and Sale action.
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a. The CVB considers this requirement met if the licensee or permittee 

notifies the CVB-IC within 3 business days of the date any individual the 

firm employs becomes aware of possible quality concerns or a problem 

regarding the preparation, testing, or distribution of a product.

Send notifications by one or more of the following means:

• U.S. mail to Director, Center for Veterinary Biologics, Inspection and 

Compliance, 1920 Dayton Avenue, Ames, IA 50010.

• Electronic mail, cvb@aphis.usda.gov.

• Fax, (515) 337-6120.

• Telephone, (515) 337-6100.

• National Centers for Animal Health (NCAH) Portal.

b. Licensees or permittees can notify the CVB biologics specialists or the 

program coordinator directly by telephone. They cannot send notifications 

to a specific CVB employee’s electronic mail or voicemail.

c. Portal notifications require the licensee or permittee to be NCAH-portal 

enabled. Notifications must be in the form of a written letter attached as a 

mail log submission.

d. The CVB-IC notification must describe the circumstances surrounding the 

concern as well as the action the firm has taken or may take.

C. Licensee and Permittee Voluntary Stop Distribution and Sale Actions

1. If the licensee or permittee takes a Voluntary Stop Distribution and Sale 

action, the CVB-IC will confirm the notification of the action. 

2. To ask the CVB-IC to approve lifting the Voluntary Stop Distribution and 

Sale action, the licensee or permittee must provide evidence to the CVB-IC 

that any deviations did not affect the product’s quality and shelf life, and the 

product is not worthless, contaminated, dangerous, or harmful.

3. If the licensee or permittee takes a Voluntary Stop Distribution and Sale 

action and finds the product unsatisfactory, the licensee or permittee must 

notify the CVB-IC. The notice should include the actions the licensee or 

permittee proposes to take concerning the product and, if applicable, user 

notification. The CVB-IC must review notifications before the licensee or 

permittee implements them. The licensee or permittee shall document all 

notifications.
VETERINARY SERVICES MEMORANDUM NO. 800.57

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V. IMPLEMENTATION/APPLICABILITY

This change is effective immediately.