Log APHIS Form 2008

CONTROLLED//PROPIN//BASIC

CVB-WI-0163.03 Page 1 of 4

Issue Date: 09Jan24

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100

Source Document: CVB-SOP-0032, Processing Serial Records

Complete hard copy APHIS Form 2008s (Form 2008s) are received and entered by the 

Inspection and Compliance group. Most Form 2008s are received from the licensed 

manufacturers through the NCAH Portal, in which case this work instruction is not applicable.

The Form 2008s are logged into LSRTIS, which is typically done between 10 a.m. and 1 p.m. 

CST.

The assigned Logger enters the Form 2008s into LSRTIS under the Serial Release module, Log 

APHIS 2008 section. The following are procedures to perform this duty.

A. Click Log APHIS 2008 and enter the following within the Create APHIS 2008 screen.

1. Establishment number (Block 2 on the Form 2008)

2. Product code (Block 5)

No decimal point. Ensure this is a valid product code for the selected establishment or 

an error message will appear after you try and save.

3. Serial number (Block 7)

a. Limit of 20 characters

b. Alpha/numeric characters only – no spaces or hyphens
Log APHIS Form 2008

CONTROLLED//PROPIN//BASIC

CVB-WI-0163.03 Page 2 of 4 

Issue Date: 09Jan24 

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100 

c. If allergenic extract, no serial number is assigned by the manufacturer. CVB

identifies each serial by designating it a number for each product code listed in 

their submission. The serial number will be the same for all; the only difference is 

the product code, i.e., 13Q4 translates: 

last 2 digits of the calendar year of the submission 

Q for quarter year

1-4 for the quarter year it covers

Jan-Mar = 1 

Apr-Jun = 2 

Jul-Sept = 3 

Oct-Dec = 4 

4. Expiration Date (if applicable) (Block 6) 

i.e., MM/DD/YYYY 

5. Site – drop down field of available sites for the firm 

6. Fill Date (if applicable) (Block 4) 

i.e., MM/DD/YYYY 

7. Is this a subserial? – An optional field to indicate if a serial is a part of a subserial 

product

8. Autogenous or Prescription Product 

a. Check if the Product is an autogenous product (1015.xx, 2051.00, 2052.xx, 

4500.xx) or a prescription product (9Pxx.xx) 

b. First Serial – check if the firm indicates the serial is a 1st serial of a harvest (no 

samples are needed for release)

c. Fifty or Less Vials – check if the inventory is less than 50 containers (if yes, no 

samples are needed for release)

9. Inventory 

a. Doses: 

# Containers (Block 10A)

Container Size (Block 10B)

Select +Add if there are multiple container sizes 

b. If no inventory is shown, enter 0 

c. NOTE: If the manufacturer is a permittee, there will be two separate dose field 

entries (Permittee Total Doses Manufactured and doses received in the United 

States). 

Follow the A.5.a. directions above for container/container size(s) for doses 

received in the United States (Block 11) 

Total Doses the foreign entity manufactured - amount in Block 10C 
Log APHIS Form 2008

CONTROLLED//PROPIN//BASIC

CVB-WI-0163.03 Page 3 of 4

Issue Date: 09Jan24

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100

d. If allergenic extracts, enter:

Total # containers

1 in container size

e. Check running total shown against total inventory in Block 10C

f. If a serial is a first serial autogenous serial, the only inventory field that will show 

is the number of total doses

10. Dose Type

doses, mL, or units only (see Unit of Measure work instructions CVB-WI0157, Unit of Measure Use and Conversion for Data Entry into LSRTIS)

11. Firm Disposition (Block 12)

a. Click on the LOV to select firm’s disposition (See CVB-WI-0129, APHIS 

Dispositions and Associated Information on Form 2008s, for the entire list of 

Firm Dispositions)

b. “Reprocess & Retest”

The new product code and serial number indicated in Block 11 of Form 2008

appears at the bottom of the screen. Select +Add if there is more than one new 

serial number.

c. “Other - Rebottling” 

The new product code and serial number indicated in Block 11 of Form 2008

appears at the bottom of the screen. Select +Add if there is more than one new 

serial number.

d. “Other - Transfer Request”

Once you enter this disposition, enter the establishment, product code, and serial 

that the inventory is being transferred to as indicated in Block 11 of Form 2008.
Log APHIS Form 2008

CONTROLLED//PROPIN//BASIC

CVB-WI-0163.03 Page 4 of 4 

Issue Date: 09Jan24 

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100 

12. Received Date (Stamp date on the Form 2008)

a. Default as today’s date

b. Ability to back date is available

13. VBI Number 

Format (10-001). This field points directly to the investigation module within 

LSRTIS, use only valid investigation numbers. 

14. Related Submissions (mail log #) This field will point directly to either IC or PEL 

Mail log numbers, if references on the Form 2008.

15. Comments 

Add any applicable comments in comment field 

16. Click Create complete the entry

B. Once the Form 2008s have been logged in, the Logger will distribute all Form 2008s to 

the assigned Biologics Compliance Assistant in their Incoming 2008s folder. 

C. Form 2008s received after 2 p.m. may be held, stamped, and logged into LSRTIS the 

following day. Hard copy 2008s may not be entered the day of receipt, though they will 

be backdated to the date of actual receipt.