Title
BFAD Circular on Alcohol Disinfectant Claims
Law
Bfad Bureau Circular No. 3, S. 1999
Decision Date
Feb 2, 1999
The Bureau of Food and Drugs clarifies that while 70% ethyl or isopropyl alcohol is effective as a disinfectant and antiseptic, it cannot be marketed as a sterilizing agent due to its limitations against certain microorganisms and its ineffectiveness on contaminated surfaces.
A

Q&A (BFAD BUREAU CIRCULAR NO. 3, S. 1999)

A disinfectant is a chemical agent which destroys microorganisms; it does not necessarily kill all microorganisms, but renders them non-harmful to health or quality of perishable goods. It is used to treat inanimate objects and may also be used topically on skin and body membranes.

An antiseptic is a chemical agent that destroys or inhibits microorganisms on living tissues, limiting or preventing the harmful effects of infection.

Examples of disinfectants mentioned are 70% ethyl or isopropyl alcohol and chlorhexidine.

Povidone Iodine, Benzalkonium chloride, and Cetrimide are examples of antiseptics given.

Sterilization means the total removal or destruction of all living microorganisms.

Chemical agents like ethylene chloride and gamma irradiation are considered sterilizers.

Rubbing alcohol should contain 68.5 - 71.5% by volume of absolute ethyl or isopropyl alcohol.

Uses include as a disinfectant for skin prior to injections and venipuncture, as a solvent, and as a pharmaceutical preservative.

No, alcohol is ineffective against bacterial spores like Clostridium tetani, welchii, and Bacillus anthracis.

No, alcohol should not be used for disinfection or sterilization of surgical and dental instruments.

No, alcohol is not suitable due to its limited penetration of organic residue and rapid evaporation.

The claim of sterilizing activity of alcohol is not acceptable; products making such claims are considered violative and subject to sanctions by BFAD.

The circular was signed by William D. Torres, Director.


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