NAICS 325411

Overview

The North American Industry Classification System (NAICS) is the federal standard for classifying business establishments to support statistical collection and analysis across the U.S. economy. Developed under the Office of Management and Budget in cooperation with Canada and Mexico, NAICS replaced the Standard Industrial Classification (SIC) system in 1997 and is revised on a five-year cycle to reflect industry changes. ¹

Under NAICS 2022, 325411 Medicinal and Botanical Manufacturing covers establishments primarily engaged in manufacturing uncompounded medicinal chemicals and their derivatives (generally as bulk active ingredients) and/or grading, grinding, and milling uncompounded botanicals. It excludes packaged compounded medicinals (classified in 325412) and most non-diagnostic biological products (classified in 325414). ²

What this NAICS covers

• Manufacturing uncompounded medicinal chemicals (bulk actives and derivatives) for further formulation. ²
• Grading, grinding, and milling uncompounded botanical drugs and herbs. ²
• Preparing botanical materials as uncompounded inputs to pharmaceutical preparation manufacturing. ²
• Producing medicinal chemical intermediates not sold in dosage form. ²
• Supplying bulk botanicals for medicinal use where no compounding or dose-form packaging occurs. ²
• Establishments whose primary outputs are medicinal chemicals or botanicals prior to tableting, encapsulating, or other dose-form preparation. ²

Related NAICS and PSC codes

Type	Code	Descriptor
NAICS	325412	Pharmaceutical Preparation Manufacturing
NAICS	325414	Biological Product (except Diagnostic) Manufacturing
PSC	6505	Drugs and Biologicals
PSC	6550	In Vitro Diagnostic Substances, Reagents, Test Kits and Sets

Scope notes: inclusions and exclusions

• Included: manufacturing uncompounded medicinal chemicals and derivatives as inputs to downstream pharmaceutical preparation. ²
• Included: grading, grinding, and milling of uncompounded botanicals and herbs for medicinal use. ²
• Excluded: packaged compounded medicinals and botanicals in dose forms (classified to 325412). ²
• Excluded: vaccines, toxoids, blood fractions, and culture media of plant or animal origin (non-diagnostic) (classified to 325414). ²
• Excluded: in vitro diagnostic substances and reagents (classified to 325413). ²

Data publication and 2022 vintage

• The Census Bureau began disseminating data based on the 2022 NAICS with the 2022 Economic Census; programs are transitioning to 2022 NAICS through 2027. ³
• Industry and product tables for Manufacturing sectors, including 325411, are available in the Economic Census by Industry data series. ⁵

Frequently asked questions

• How does 325411 differ from 325412?
  325411 covers uncompounded medicinal chemicals and processing of botanicals (grading, grinding, milling). In contrast, 325412 covers compounded pharmaceutical preparations, including formulating dosage forms and packaging finished drugs and some in-vivo diagnostic substances. They represent adjacent stages in the pharmaceutical value chain. ²

• Are vaccines or blood products part of 325411?
  No. Vaccines, toxoids, blood fractions, and culture media of plant or animal origin (except diagnostic uses) are classified under 325414. Establishments focused on these biological products are not part of 325411. ²

• Do in vitro diagnostic reagents fall under 325411?
  No. In vitro diagnostic substances and reagents are classified in 325413. If your product line consists primarily of diagnostic reagents or test kits, the appropriate NAICS is 325413, not 325411. ²

• Which PSC codes commonly align to supplies produced in 325411?
  Common supply PSCs include 6505 Drugs and Biologicals and, when applicable, 6508 Medicated Cosmetics and Toiletries. Diagnostic reagents typically align to 6550. Always confirm alignment using the current PSC Manual for scope and exclusions. ⁴

• Is 325411 included on SBA’s WOSB eligible NAICS list?
  Yes. SBA identifies 325411 as eligible for the Women-Owned Small Business Federal Contracting Program. Firms should verify their eligibility and ensure that their primary activities align with the industry definition when certifying. ⁶

Useful resources

• G2X — NAICS 325411 overview
• U.S. Census Bureau — NAICS 2022: 325411 Medicinal and Botanical Manufacturing
• U.S. Census Bureau — Implementation of the 2022 NAICS (timeline and program adoption)
• GSA/Acquisition.gov — Product and Service Codes (PSC) Manual (current edition)
• U.S. Census Bureau — Economic Census by Industry (Manufacturing sector tables)
• SBA — Eligible NAICS for the Women-Owned Small Business Federal Contracting Program

References

1. U.S. Census Bureau — Classifying Businesses (NAICS history; OMB adoption in 1997). https://www.census.gov/about/history/historical-censuses-and-surveys/census-programs-surveys/economic/classifying-businesses.html
2. U.S. Census Bureau — NAICS 2022, Sector 31–33 Manufacturing (includes industry definition and cross-references for 325411/325412/325414). https://www.census.gov/naics/resources/archives/sect31-33.html
3. U.S. Census Bureau — Implementation of the 2022 NAICS (review cycle, program transition, and First Look release). https://www.census.gov/library/reference/code-lists/naics/2022/implementation-timeline.html
4. Acquisition.gov — Product and Service Code (PSC) Manual, April 2025. https://www.acquisition.gov/sites/default/files/manual/PSC%20Manual%20April%202025.pdf
5. U.S. Census Bureau — Economic Census by Industry (2022 sector tables). https://www.census.gov/programs-surveys/economic-census/data/tables/industry.html
6. U.S. Small Business Administration — Eligible NAICS for the Women-Owned Small Business Federal Contracting Program. https://www.sba.gov/document/support-eligible-naics-women-owned-small-business-federal-contracting-program