November 4, 1999 

VETERINARY SERVICES MEMORANDUM NO. 800.74 

Subject: Preparation and Distribution of Sterile Diluent 

To: Biologics Licensees, Permittees, and Applicants 

Directors, Center for Veterinary Biologics 

I. PURPOSE 

This memorandum provides guidelines concerning the production and distribution of 

Sterile Diluent under 9 CFR 112.3, 112.6, and 113.54. 

II. CANCELLATION 

This memorandum cancels Veterinary Services Memorandum No. 800.74 dated May 21, 

1985. 

III. BACKGROUND 

The Center for Veterinary Biologics (CVB) does not consider Sterile Diluent to be a 

veterinary biological product; however, licensees must provide the proper amount of 

Sterile Diluent with each licensed veterinary biological product when diluent is required 

for rehydration or dilution of the product. APHIS specifies the requirements for Sterile 

Diluent for licensed veterinary biological products in 9 CFR 112.3 and 112.6 (packaging 

and labeling) and in 9 CFR 113.54 (production and testing). This memorandum provides 

further guidance concerning the production of Sterile Diluent in USDA-licensed 

veterinary biologics production facilities and in unlicensed facilities. 

IV. GUIDELINES 

A. Diluents For Licensed Products

1. Production in Licensed Establishments - Licensees may prepare Sterile 

Diluent in USDA-licensed establishments according to 9 CFR 113.54. 

2. Production in Unlicensed Facilities - Unlicensed facilities may produce 

Sterile Diluent for use with licensed veterinary biological products provided: 

a. The Center for Veterinary Biologics-Inspection and Compliance 

(CVB-IC) inspects the diluent manufacturer’s facilities and finds them to 

be acceptable to produce Sterile Diluent, 
Veterinary Services Memorandum NO. 800.74 2 

b. The licensee or applicant files an Outline of Production 

describing the diluent manufacturer’s procedures for production of Sterile 

Diluent with the Center for Veterinary Biologics-Licensing and Policy 

Development (CVB-LPD), 

c. The diluent manufacturer gives CVB-IC the authority to inspect 

their production facilities and all records of production and testing at any 

time, 

d. The licensee files copies of the diluent manufacturer’s records of 

production and testing of each serial at the licensed establishment, 

e. For each serial, the licensee conducts all tests specified in the 

Outline of Production, including a test to ensure that such Sterile Diluent 

is compatible with its product(s), in licensed facilities, 

f. Diluent manufacturers ship each serial of Sterile Diluent required 

to be packaged and shipped with the final container(s) of licensed 

biological product(s) to the licensed establishment for testing, finishing, 

and distribution, and 

g. Diluent manufacturers label, package, and ship Sterile Diluent 

authorized to be packaged and shipped separately from the final 

container(s) of the licensed veterinary biological product as specified in 

9 CFR 112.6(d) and: 

(1) Meet all conditions in items a. through e. above, 

(2) For each Sterile Diluent, file with CVB-LPD an Outline 

of Production or Special Outline that provides a complete 

description of all procedures and conditions, 

(3) Provide for sample selection, label accountability, 

and inventory control adequate to ensure compliance with the 

regulations and the outline requirements, and 

(4) Provide copies of pertinent shipping invoices for the 

licensed establishment to file with its records of each serial of 

biological product. 

B. Diluents for Other Purposes

1. Regulatory Authority - The Center for Veterinary Biologics does not 

regulate Sterile Diluents produced for purposes other than use with licensed 

veterinary biological products; however, other authorities may regulate such 

diluents. 
Veterinary Services Memorandum NO. 800.74 3 

2. Conditions for Production - Licensed establishments may prepare 

Sterile Diluents not intended for use with veterinary biological products in USDA 

licensed facilities, provided such diluent labels: 

a. Do not contain the U.S. Veterinary Biologics Establishment 

License Number, and 

b. Do not contain recommendations or directions for use with 

licensed veterinary biological products. 

/s/ Thomas E. Walton for 

Alfonso Torres 

Deputy Administrator 

Veterinary Services