APHIS Veterinary Biologic Packaging, Labeling, and Records — What Licensed Manufacturers Must Put on the Label and Keep in the Files

Every licensed veterinary biologic — from cattle vaccines to poultry bacterins — must clear two APHIS gates before it reaches a single animal: label approval and a pre-release test summary submission. Miss either, and the product cannot legally enter commerce, regardless of whether it works.

Current Rule (2026)

What This Rule Does

A licensed veterinary biologic — a vaccine, antiserum, bacterin, or diagnostic product used in animals — must carry specific label information before it leaves the manufacturer and must be accompanied by records that allow APHIS to trace every serial from production through distribution. Nine CFR Parts 112 and 116 establish these requirements for licensed establishments and importers.

Part 112 governs packaging and labeling: what must appear on the final container label, what must appear on carton labels, how diluent labels are handled, when APHIS approval of a label is required, and what special cautions must accompany products with particular biological risks. Part 116 governs the records and reports that manufacturers must maintain throughout the production lifecycle — inventory, label records, sterilization logs, test summaries, animal records, and adverse event reports — along with how long those records must be kept and what must be submitted to APHIS before a serial may be released for sale.

Together, Parts 112 and 116 form the product integrity backbone of APHIS's veterinary biologic licensing system.

Key Mechanics

9 CFR Parts 112 and 116 operate as an integrated pre-market and post-market control system:

1. Label approval gate (Part 112) — Before a serial enters commerce, the label must be reviewed and approved in writing by APHIS. The manufacturer submits draft labels via APHIS transmittal forms; once approved, those labels may be used without resubmission for the life of the product license. A "master label system" allows minor variations (container sizes, languages) under a single approved master.

2. Pre-release test submission gate (Part 116, § 116.7) — Before any serial may be marketed or exported, the manufacturer must submit a summary of all test results to APHIS on Form 2008. APHIS reviews the data before the product enters commerce.

3. Dual licensing requirement (9 CFR Part 102) — Every manufacturer must hold both a U.S. Veterinary Biologics Establishment License (facility) and a separate U.S. Veterinary Biological Product License (each product). A lapse in the establishment license suspends all product licenses at that facility.

4. Record retention tied to product shelf life — Records must be retained for 2 years after the expiration date of the last serial they cover; because biologics can have multi-year shelf lives, production records may remain legally required for 5–7 years from manufacture. Adverse event records carry a separate 3-year retention clock from the date of receipt.

5. Distributor independence — Distributors have their own disposition recordkeeping obligations under § 116.2 and cannot rely on manufacturer records to satisfy their APHIS compliance duties.

Key Provisions — Part 112: Packaging and Labeling

• § 112.1 — General applicability: every biological product prepared at a licensed establishment or imported must be packaged and labeled as required by Part 112 before it is removed from the establishment or presented for importation; products imported solely for research and evaluation are subject only to § 112.9's simplified requirements
• § 112.2 — Required label content: final container labels, carton labels, and package enclosures (inserts, circulars, leaflets) must include — the complete true name of the product (identical to the product license); the serial number and subserial number, if applicable; the net contents (dose, volume, or weight); the name and address of the licensee (or permittee for imports); expiration date; storage requirements; and directions for use; the complete name must be prominently lettered and given equal emphasis with any trade name
• § 112.3 — Diluent labels: each container of diluent packaged with a desiccated (freeze-dried) biologic must be separately labeled identifying it as "Sterile Diluent," the product it accompanies, the volume, storage requirements, and expiration date; when a licensee uses the same diluent for all desiccated products, simplified labeling is permitted if the licensee's identification and storage systems ensure correct matching
• § 112.4 — Distributor and permittee labels: labels used by subsidiaries, divisions, distributors, and foreign permittees must be affixed by the licensee at the licensed establishment where the product is produced; the licensee remains responsible for label compliance regardless of whose name appears on the label
• § 112.5 — Label review and approval: labels for products sold in general commerce must be submitted to APHIS for review and written approval before use; submissions go through APHIS transmittal forms available on the APHIS website; approved labels may be used without resubmission as long as the product license remains valid; a "master label system" allows minor label variations (different container sizes, different languages) under a single approved master without individual approval for each variant
• § 112.6 — Packaging rules: multi-dose containers may be packaged one or more per carton with the appropriate volume of diluent; cartons containing more than one final container must include labeling that accounts for the total contents; the packaging must conform to the filed Outline of Production for that product
• § 112.7 — Special cautions: products containing live Newcastle Disease virus must include a caution statement about the risk of eyelid inflammation in humans and a warning to avoid eye contact; infectious bronchitis virus products must carry specified warnings; biological products with other particular hazards must include cautions consistent with the approved product outline
• § 112.8 — Export-only products: the standard packaging and labeling rules apply to products exported from the United States; products packaged and labeled for export that have left the licensed establishment may not be returned to the establishment unless the label is removed and the product is re-examined, tested, and re-packaged; once exported, the product must be relabeled if it re-enters U.S. commerce
• § 112.9 — Research and evaluation imports: a biologic imported under a permit for research and evaluation purposes need not meet the full Part 112 requirements; the label must identify the product, manufacturer name and address, and provide instructions for proper use including all warnings and cautions needed for safe use by the permittee

Key Provisions — Part 116: Records and Reports

• § 116.1 — Scope: every licensee, permittee, and foreign manufacturer of biologics imported into the United States must maintain detailed records at the establishment sufficient to give a complete accounting of all activities; records must be available for APHIS inspection at any time
• § 116.2 — Inventory and disposition records: records must show the quantity and location of each product being prepared, in storage, and in distribution channels; disposition records must track every sale, shipment, transfer, or other disposal of each serial and subserial — including who received it, when, and in what quantity; distributors and permittees have the same disposition recordkeeping obligation as licensees
• § 116.3 — Label records: each licensee and permittee must maintain a current list of all approved labels in use, identified by product code number, container size, label number and date assigned, and the date submitted to and approved by APHIS; out-of-date or superseded labels must be identified as such
• § 116.4 — Sterilization and pasteurization records: records of all sterilization and pasteurization processes must be made using automatic recording devices or an equally reliable system; records must identify the specific ingredients, equipment, or product subjected to each sterilization cycle
• § 116.5 — Reports to APHIS: when the Administrator requires it, licensees, permittees, and foreign manufacturers must submit reports on product development and preparation, market suspensions, and product recalls; the obligation to report is triggered by APHIS request, not merely by an adverse event
• § 116.6 — Animal records: complete records must be kept for all animals used or maintained at the licensed establishment — test results, antigens and treatments administered, production and maintenance logs, necropsy records, and all other pertinent animal health data
• § 116.7 — Test records and pre-release summaries: detailed records of all tests performed on each serial and subserial must be maintained by the licensee; before any serial may be marketed or exported, a summary of those test results must be submitted to APHIS on APHIS Form 2008 (or equivalent); this pre-release submission requirement means that APHIS reviews test data before the product enters commerce
• § 116.8 — Completion and retention: all records — except disposition records and adverse event records — must be completed before any portion of a serial may be marketed; all records must be retained at the licensed establishment for a period of 2 years after the expiration date of the last serial to which they relate; disposition records must be retained for 2 years after the last recorded disposition; adverse event records must be retained for 3 years after the adverse event report is received
• § 116.9 — Adverse event recording and reporting: licensees and permittees must maintain a detailed record for every adverse event report received for any product they produce or distribute; adverse event report forms and guidance are available on the APHIS website; records must be retained for 3 years from receipt; the Administrator may require licensees to submit adverse event reports to APHIS under specified conditions

Implementing Regulations — Licensing

The licensing framework for veterinary biologic manufacturers operates under 9 CFR Part 102 — Licenses for Biological Products. Key provisions:

• § 102.2 — License requirements: every person who prepares biological products subject to the Virus-Serum-Toxin Act must hold both an unexpired U.S. Veterinary Biologics Establishment License (covering the facility) and a U.S. Veterinary Biological Product License (covering each specific product); these are two separate licenses — the facility license does not authorize production of any product; each product requires its own license
• § 102.3 — Application process: establishment license applicants submit a written application to the APHIS Administrator; product license applicants separately apply for each product; applications must include all information needed for APHIS to evaluate the facility and product for compliance with the regulations
• § 102.4 — Establishment license issuance: APHIS conducts a physical inspection of the facility before issuing an establishment license to verify that conditions, equipment, facilities, and preparation methods conform to regulatory requirements; a facility cannot receive a product license until it first holds a valid establishment license
• § 102.5 — Product license contents: a U.S. Veterinary Biological Product License is supplementary to the establishment license and specifies the establishment, the product name (matching the product license application), the species for which the product is intended, and any special conditions; the product license is not transferable between establishments
• § 102.6 — Conditional licenses: APHIS may issue a conditional product license when an emergency condition, limited market need, local situation, or special circumstance (including production solely for intrastate use) exists and the product does not yet meet all standard requirements; conditional licenses allow manufacturers to respond to disease outbreaks or niche markets while APHIS gathers additional data

Both licenses are required to market a veterinary biologic in the United States. A lapse in the establishment license automatically suspends all product licenses associated with that facility. Manufacturers should maintain continuous license validity and notify APHIS of any changes to facilities, processes, or ownership that may affect license status.

How It Affects You

Licensed veterinary biologic manufacturers must submit labels to APHIS for review and written approval before use — not after. The label approval requirement is pre-market, and using an unapproved label is a violation regardless of whether the label content itself is accurate. Use the master label system to manage variation across container sizes and markets without seeking individual approvals for each variant.

The pre-release test summary requirement (§ 116.7 via APHIS Form 2008) creates a formal gate between production and commerce. A serial cannot enter the market until the test summary has been submitted and cleared. Build this submission step into your release workflow; delays in submitting to APHIS delay commercial release.

Record retention timelines are product-specific, not calendar-based. Because records must be kept for 2 years after the expiration date of the last serial they cover, and because biologic products can have multi-year shelf lives, production records may need to be kept for 5–7 years or more from the actual date of manufacture.

Distributors have independent disposition recordkeeping obligations under § 116.2. If you distribute a licensed veterinary biologic, you must track and retain records of every sale and shipment — you cannot rely on the manufacturer's records to satisfy your own APHIS compliance obligation.

Adverse event reporting has a separate 3-year retention requirement and a separate mandatory reporting pathway. The adverse event record must be maintained whether or not APHIS formally requested a report — the receipt of the adverse event report by the licensee starts the retention clock.

Special label cautions for Newcastle Disease products, infectious bronchitis products, and other high-risk biologics are required by § 112.7 regardless of what appears in the approved product outline. These cautions exist to protect handlers and users from occupational exposure risks — they cannot be waived.

Legal Authority

This rule implements the Virus-Serum-Toxin Act (VSTA), codified at 21 U.S.C. §§ 151–159. The complete statutory map:

• 21 U.S.C. § 151 — Core prohibition: no person may prepare, sell, barter, exchange, or ship any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product intended for treating domestic animals; production in the United States must be conducted under USDA rules and only at facilities holding a valid, unsuspended, unrevoked license. This is the foundational authority for APHIS's licensing, labeling, and recordkeeping requirements under 9 CFR Parts 112 and 116.
• 21 U.S.C. § 152 — Import prohibition and permit requirement: no veterinary biologic may be imported into the United States without a permit from the Secretary of Agriculture; Canadian imports also require either a U.S. permit or a Canadian certificate accepted by the Secretary.
• 21 U.S.C. § 153 — Import inspection and denial of entry: the Secretary may have imported veterinary biologics inspected by the Bureau of Animal Industry; products found to be worthless, contaminated, dangerous, or harmful must be denied entry and destroyed or returned at the owner's expense.
• 21 U.S.C. § 154 — Rulemaking and licensing authority: the Secretary may promulgate regulations to prevent harmful or contaminated veterinary biologics from being prepared, sold, or shipped; the Secretary may issue, suspend, or cancel establishment and product licenses.
• 21 U.S.C. § 155 — Import permit procedures (details governing how the Secretary issues and conditions import permits for veterinary biologics).
• 21 U.S.C. § 156 — License conditions and suspension: licenses must permit USDA inspection of the establishment, products, and preparation methods; after hearing, the Secretary may suspend or cancel a license if it is being used to prepare, sell, ship, or import any harmful veterinary biologic.
• 21 U.S.C. § 157 — Inspection authority: USDA personnel designated by the Secretary may inspect, at any hour of the day or night, establishments that prepare veterinary biologics for sale, trade, or shipment.
• 21 U.S.C. § 158 — Criminal penalties: violations of the VSTA are misdemeanors punishable by a fine of up to $1,000, imprisonment of up to one year, or both.
• 21 U.S.C. § 159 — Enforcement procedures and congressional findings: enforcement must follow procedures in 21 U.S.C. §§ 672–674; Congress found that veterinary biologics are in interstate or foreign commerce and that federal regulation is necessary to prevent burdens on that commerce.

Recent Rulemakings

The labeling and recordkeeping framework under 9 CFR Parts 112 and 116 is longstanding and has not been substantially amended in recent years. The most significant recent regulatory activity in the APHIS veterinary biologics space has involved:

• Outline of Production (OOP) updates — APHIS regularly processes amendments to individual product outlines (the product-specific manufacturing blueprint tied to each product license), but these are product-specific actions rather than broad regulatory rewrites.
• Conditional licensing use during disease outbreaks — APHIS has issued conditional licenses under § 102.6 to allow faster access to vaccines during outbreaks (e.g., avian influenza response periods), with the labeling and recordkeeping requirements under Parts 112 and 116 still applying to conditional license products.
• Electronic records modernization — APHIS has indicated interest in allowing electronic recordkeeping systems as compliant alternatives to paper-based records under Part 116, consistent with broader federal e-records initiatives, though no formal final rule has been issued as of 2026.

Monitor the APHIS Center for Veterinary Biologics (CVB) website and the Federal Register (docket search: "APHIS veterinary biologics") for any updates to Parts 112 and 116.

Pending Action

No major rulemakings affecting Parts 112 or 116 are pending as of early 2026. APHIS regulatory priority for veterinary biologics has focused on product-specific licensing actions and outbreak response rather than structural changes to labeling and recordkeeping requirements. Watch for any Federal Register notices from APHIS CVB regarding modernization of electronic recordkeeping standards.

Frequently Asked Questions

Does APHIS approve every label before a product can be sold? Yes. Under § 112.5, labels for products sold in general commerce must receive written APHIS approval before use. This is a pre-market requirement — using an unapproved label is a regulatory violation even if the label content is accurate. The master label system helps manufacturers manage label variations without seeking individual approvals for each container size or language version.

What happens if a serial fails to pass APHIS review of the pre-release test summary? The serial cannot be marketed or exported. Under § 116.7, the pre-release test summary submitted via APHIS Form 2008 is reviewed before the product enters commerce. If APHIS identifies a problem, the serial may be placed on hold or the licensee may be required to conduct additional testing. There is no workaround — commercial release is legally blocked until the submission requirement is satisfied.

How long do manufacturers have to keep production records? It depends on the product's shelf life, not a fixed calendar date. Under § 116.8, records must be retained for 2 years after the expiration date of the last serial they cover. Because many veterinary biologics carry 18–36 month expiration windows, a batch manufactured in 2024 with an expiration date of 2026 would require record retention through 2028. For manufacturers with rolling production, the practical retention window often runs 5–7 years from manufacture date.

Are distributors required to keep their own records, or can they rely on manufacturer records? Distributors must keep their own records. Section 116.2 independently obligates distributors to track and retain disposition records — every sale, shipment, transfer, or other disposal of each serial and subserial. Relying on the manufacturer's records to satisfy APHIS compliance is not permitted.

What is the difference between the Establishment License and the Product License? Under 9 CFR Part 102, these are two entirely separate licenses. The Establishment License (§ 102.2) covers the facility — it certifies that the physical plant, equipment, and preparation methods meet APHIS standards. The Product License covers a specific biologic product and is supplementary to the establishment license. A facility holding only an establishment license may not produce any licensed product; each product requires its own license. A lapse in the establishment license automatically suspends all product licenses at that facility.

What To Watch

If you manufacture, import, or distribute licensed veterinary biologics, these are the compliance pressure points most likely to create problems:

• Label change management: Any change to an approved label — even a font adjustment or container size update — requires a new APHIS submission unless it falls within an approved master label variation. Build a label change review process that catches changes before product is printed or released.
• Form 2008 backlog: The pre-release test summary requirement under § 116.7 is a hard gate. If your quality team or regulatory affairs team is understaffed, Form 2008 submissions can create a release bottleneck. Map this step explicitly in your release workflow.
• Retention calendar audits: Because retention periods are tied to expiration dates rather than manufacture dates, standard document destruction schedules tied to production years will destroy records prematurely. Maintain retention schedules tied to lot-specific expiration dates.
• Adverse event intake: The 3-year retention clock for adverse event records (§ 116.9) starts on the date of receipt, not the date of the event. Ensure your intake process timestamps reports at receipt and triggers an automatic record retention flag.

Related Pages

• APHIS Veterinary Biologics Program — the parent licensing framework (establishment license, product license, serial release testing) of which labeling and recordkeeping are one component
• APHIS Veterinary Biologic Facility Requirements — the facility design and equipment rules at 9 CFR 108 that operate alongside labeling requirements
• APHIS Veterinary Biologic Patent Term — patent term restoration for veterinary biologics regulated under the same VSTA framework
• Animal Health Protection — APHIS disease control programs that use CVB-licensed biologics as official tools