MSDS Number: FENTC Effective Date: 12/10/2003 Supercedes: 6/6/2002
Eye Contact:
Mild irritant but will also have a strong narcotic effect (pupil constriction) and the eye may serve as an
absorption route to the body in general.
Chronic Exposure:
Caution, may be habit forming.
Aggravation of Pre-existing Conditions:
Rare individuals may have prior hypersensitivity from clinical administration of fentanyl; such individuals
should obtain competent medical advice regarding handling of fentanyl products.

4. First Aid Measures
Inhalation:
Remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a
physician.
Ingestion:
Induce vomiting immediately as directed by medical personnel. Never give anything by mouth to an
unconscious person.
Skin Contact:
Immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and
shoes. Call a physician, immediately. Wash clothing before reuse.
Eye Contact:
Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids
occasionally. Get medical attention immediately.
Note to Physician:
The principal sign of serious overdose to fentanyl include stupor and respiratory depression. Treatment for
these effects due to fentanyl is the same as for overdose by other opioids: airway maintenance, ventilation
support, and administration of a narcotic antagonist such as naloxone (Narcan?) beginning with 0.4 to 2 mg
intravenously and repeating every three minutes as clinically indicated. Intramuscular or subcutaneous
administration may be necessary if the intravenous route is not available.


5. Fire Fighting Measures
Fire:
As with most organic solids, fire is possible at elevated temperatures or by contact with an ignition source.
Explosion:
No information found.
Fire Extinguishing Media:
Water spray, dry chemical, alcohol foam, or carbon dioxide.
Special Information:
In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus
with full facepiece operated in the pressure demand or other positive pressure mode. Follow handling
guidance appropriate for OEB-3 potent compounds, (see Section 7).

6. Accidental Release Measures
Ventilate area of leak or spill. Remove all sources of ignition. Wear appropriate personal protective equipment
as specified in Section 8, and follow handling guidance appropriate for OEB-3 potent compounds, (see
Section 7). Isolate hazard area. Keep unnecessary and unprotected personnel from entering. All clean-up
operations should be witnessed by more than one individual.
Spills: Carefully sweep up material into an appropriate container and save for reclamation or disposal. Use
non-sparking tools and equipment. Do not flush to sewer! The amount of material collected should be
assessed and documented.



MSDS Number: FENTC Effective Date: 12/10/2003 Supercedes: 6/6/2002

7. Handling and Storage
Keep in a tightly closed container, stored in a cool, dry, ventilated area. Protect against physical damage.
Containers of this material may be hazardous when empty since they retain product residues (dust, solids);
observe all warnings and precautions listed for the product. CONTROLLED SUBSTANCE. Location of storage
area must comply with all Drug Enforcement Agency regulations.

Fentanyl Citrate has potent pharmacological activity and is classified as an OEB-3* material. Handling
practices for OEB-3 substances are described below:
Laboratory

* Wear appropriate gloves, lab coat, and safety glasses. Use good lab practices.
* A designated area is required for handling compounds.
* Work surfaces are to be cleaned daily. If lab bench absorbent paper is used, it is to be changed at least
daily.
* High-energy operations such as milling, particle sizing, spraying or fluidizing should be done within an
approved emission control or containment system.
* Develop cleaning procedures and techniques that limit potential exposure.
* Powders Handling:
To prevent contamination and overexposure, no open handling of powder should be allowed. Powder
handling operations are to be done in a powders weighing hood, a glove box, or other equivalent ventilated
containment system. In situations where these ventilated containment hoods have not been installed, a non-
ventilated enclosed containment hood should be used. Pending changes resulting from additional air
monitoring data, up to 300 mg can be handled outside of an enclosure provided that no grinding, crushing or
other dust-generating process occurs. An air-purifying respirator (P95 or other type providing a higher level of
protection) should be worn by all personnel in the immediate area in cases where non-ventilated containment
is used, where significant amounts of material (e.g., more than 2 grams) are used, or where the material may
become airborne (as through grinding, etc.). Powder should be put into solution or a closed or covered
container after handling. If using a ventilated enclosure that has not been validated, wear a half-mask
respirator equipped with HEPA cartridges until the enclosure is validated for use.

* Solutions Handling:
- Solutions can be handled outside a containment system or without local exhaust ventilation during
procedures with no potential for aerosolization. If the procedures have a potential for aerosolization, an air-
purifying respirator (P95 or other type providing a higher level of protection) is to be worn by all personnel in
the immediate area.
- Solutions used for procedures where aerosolization may occur (e.g., vortexing, pumping) are to be handled
within a containment system or with local exhaust ventilation. In situations where this is not feasible (may
include animal dosing), an air-purifying respirator (P95 or other type providing a higher level of protection) is to
be worn by all personnel in the immediate area.
- If using a ventilated enclosure that has not been validated, wear a half-mask respirator equipped with HEPA
cartridges until the enclosure is validated for use.
-Ensure gloves are protective against solvents in use.

Pilot Plant and Production

* Wear appropriate gloves; lab coat, nylon coveralls or disposable Tyvek suit; safety glasses, safety shoes,
and disposable booties. Use good manufacturing practices (i.e., cGMPs).
* Protective garment (coveralls, Tyvek, lab coat) is not to be worn outside the work area.
* Clean/dirty/decontamination areas are to be established.
* Negative/positive air pressure relationships and buffer zones required (i.e., ante-room/degowning
room/airlock).
* Area access is to be restricted.
* High-energy operations such as milling, particle sizing, spraying or fluidizing should be done within an
approved emission control or containment system.
* Develop cleaning procedures and techniques that limit potential exposure.

* Powders Handling
- Emphasis is to be placed on closed material transfer systems and process containment, with no open

MSDS Number: FENTC Effective Date: 12/10/2003 Supercedes: 6/6/2002
No information found.

10. Stability and Reactivity
Stability:
Discolors on exposure to light.
Hazardous Decomposition Products:
Burning may produce carbon monoxide, carbon dioxide, nitrogen oxides.
Hazardous Polymerization:
Will not occur.
Incompatabilities:
No information found.
Conditions to Avoid:
No information found.

11. Toxicological Information
Fentanyl: Oral rat LD50: 18 mg/kg
Cancer Lists
---NTP Carcinogen---
Ingredient Known Anticipated IARC Category
Fentanyl citrate (990-73-8) No No None


12. Ecological Information
Environmental Fate:
No information found.
Environmental Toxicity:
No information found.

13. Disposal Considerations
Notify site Drug Enforcement Agency compliance officer and local DEA office for appropriate disposal
procedures. Processing, use or contamination of this product may change the waste management options.
State and local disposal regulations may differ from federal disposal regulations.
Follow handling guidance appropriate for OEB-3 potent compounds, (see Section 7).

Dispose of container and unused contents in accordance with federal, state and local requirements.

14. Transport Information
Domestic (Land, D.O.T.)
Proper Shipping Name: TOXIC SOLID, ORGANIC, N.O.S. (Propanamide, N-phenyl-N-[1-(2-
phenylethyl)-4-piperidinyl]-, 2-hydroxy-1,2,3-propanetricarboxylate)
Hazard Class: 6.1
UN/NA: UN2811 Packing Group: II
Information reported for product/size: all sizes



15. Regulatory Information
Chemical Inventory Status
---Canada---
Ingredient TSCA EC Japan Australia Korea DSL NDSL Phil.

MSDS Number: FENTC Effective Date: 12/10/2003 Supercedes: 6/6/2002
Fentanyl citrate (990-73-8) Exempt Yes No Yes No No No No

Federal, State & International Regulations
---SARA 302--- -----------SARA 313----------- -RCRA- -TSCA-
Ingredient RQ TPQ List Chemical Catg. CERCLA 261.33 8(d)
Fentanyl citrate (990-73-8) No No No No No No No

Chemical Weapons Convention: No TSCA 12(b): No CDTA: No
SARA 311/312: Acute: Yes Chronic: Yes Fire: No Pressure: No Reactivity: No (Pure / Solid)
Australian Hazchem Code: 2XE Australian Poison Schedule: S8
WHMIS: This MSDS has been prepared according to the hazard criteria of the Controlled Products
Regulations (CPR) and the MSDS contains all of the information required by the CPR.


16. Other Information
NFPA Ratings:
Health: 4 Flammability: 1 Reactivity: 1
Label Hazard Warning:
DANGER! MAY BE FATAL IF SWALLOWED, INHALED OR ABSORBED THROUGH SKIN. POTENT
NARCOTIC.
Label Precautions:
Do not breathe dust.
Do not get in eyes, on skin, or on clothing.
Keep container closed.
Use only with adequate ventilation.
Wash thoroughly after handling.
Label First Aid:
If swallowed, induce vomiting immediately as directed by medical personnel. Never give anything by mouth to
an unconscious person. If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is
difficult, give oxygen. In case of contact, immediately flush eyes or skin with plenty of water for at least 15
minutes while removing contaminated clothing and shoes. Wash clothing before reuse. In all cases, get
medical attention.
Product Use:
Medication: Analgesic; for relief of moderate to moderately severe pain.
Revision Information:
MSDS Section(s) changed since last revision of document include: 8, 14.
Disclaimer:
Mallinckrodt provides the information contained herein in good faith but makes no representation as to its
comprehensiveness or accuracy. This document is intended only as a guide to the appropriate precautionary
handling of the material by a properly trained person using this product. Individuals receiving the information
must exercise their independent judgment in determining its appropriateness for a particular purpose.
MALLINCKRODT MAKES NO REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED,
INCLUDING WITHOUT LIMITATION ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE WITH RESPECT TO THE INFORMATION SET FORTH HEREIN OR THE
PRODUCT TO WHICH THE INFORMATION REFERS. ACCORDINGLY, MALLINCKRODT WILL NOT BE
RESPONSIBLE FOR DAMAGES RESULTING FROM USE OF OR RELIANCE UPON THIS INFORMATION.
Prepared By: Environmental Health & Safety
Phone Number: (314) 654-1600 (U.S.A.)






Fentanyl citrate