Guidance for Industry
Possible Dioxin/PCB
Contamination of Drug and
Biological Products
U.S. Department of Health and Human Services
Food and Drug Administration
August 1999
Compliance Guidance for Industry
Possible Dioxin/PCB
Contamination of Drug and
Biological Products
Additional copies of this Guidance are available from:
 Office of Training and Communications
 Division of Communications Management
Drug Information Branch, HFD-210
Center for Drug Evaluation and Research
Food and Drug Administration
 5600 Fishers Lane, Rockville, MD  20857
(Phone 301-827-4573)
Internet:   http://www.fda.gov/cder/guidance/index.htm.
or
 Office of Communication, Training and
Manufacturers Assistance, HFM-40
Center for Biologics Evaluation and Research
 Food and Drug Administration
1401 Rockville Pike, Rockville, MD 20852-1448
Internet:   http://www.fda.gov/cber/guidelines.htm.
Fax: 1-888-CBERFAX or 301-827-3844
Mail: the Voice Information System at 800-835-4709 or 301-827-1800
or
Communications Staff (HFV-12)
Center for Veterinary Medicine (CVM)
7500 Standish Place, Rockville, MD 20855
(Tel) 301-594-1755
http://www.fda.gov/cvm
U.S. Department of Health and Human Services
Food and Drug Administration
August 1999
Compliance 1
Guidance for Industry
Possible Dioxin/PCB Contamination
of Drug and Biological Products
I. INTRODUCTION
This guidance is intended for manufacturers using materials derived from animal sources
in the manufacture of human or animal drugs or biological products.  During the period
from January through June 1999, some poultry, swine, and ruminants (cattle, sheep, and
goats) in several EU (European Union) countries were fed feed contaminated with
dioxins and PCBs (polychlorinated biphenyls).  As a result, animals that received the
contaminated feed became contaminated with dioxins and PCBs.  Manufacturers who are
using materials from such animal sources in the manufacture of their products should
verify that the materials they are using are not from animals affected during the
contamination incident, or conduct suitable testing of the materials.
II. RECOMMENDATIONS FOR ASSESSING ANIMAL DERIVED
MATERIALS
Because of the potential contamination of animals in Belgium, France, and the
Netherlands, manufacturers should investigate the origin of animal derived materials
(e.g. egg yolk lecithin, egg phospholipids, pancrelipase) they are using to manufacture
human or animal drugs or biological products.  This includes drug substances and
excipients.  If materials are found to be derived from poultry, swine, or ruminants,
manufacturers should obtain certification from their suppliers that the animal derived
materials (including the eggs from chickens) used in drugs or biological product
manufacturing do not come from animals raised in any of these three countries during the
period January through June 1999.  If the animal source of manufacturing materials
cannot be certified, the material should not be used to manufacture human or animal
drugs or biological products.  Alternatively, the materials should be tested for the presence
of dioxins or PCBs prior to use.  One analytical method suitable for foods that may be
adapted for analyzing PCBs in pharmaceuticals can be found in the FDA's Pesticide
Analytical Manual, Vol. 1, Chap. 3, sect. 303 or 304.2
                                               
1 This guidance has been prepared by the Food and Drug Administration.  This
guidance represents the Agencys current thinking on possible dioxin/PCB contamination of animal source
material in EU countries.  It does not create or confer any rights for or on any person and does not operate
to bind FDA or the public.  An alternative approach may be used if such approach satisfies the
requirements of the applicable statutes, regulations, or both.
2 This is available on the FDA Web site (www.cfsan.fda.gov/~frf/pamil.html). If products have already been produced using materials that cannot be certified, PCB or
dioxin testing of the final product should be performed.  If the presence of PCBs or
dioxins is detected, manufacturers should contact the appropriate contact person listed
below to discuss whether the release of the product is acceptable.
The Agency is conducting a sampling and testing program for dioxins and PCBs in drugs
and biologics originating from EU countries.
Contact Persons
For animal drug products, contact John Matheson, Center for Veterinary Medicine, 301-
827-6649.
For human drug products, contact Eric Duffy, Center for Drug Evaluation and Research,
301-827-7310.
For biological products, contact Christopher Joneckis, Center for Biologics Evaluation
and Research, 301-827-5138.