Question & AnswerQ&A (BFAD BUREAU CIRCULAR NO. 05)
Hemodialysis products, specifically hemodialysis solutions, are classified as DRUGS according to BFAD Bureau Circular No. 05, s. 2003.
The directive took effect immediately as of April 10, 2003.
Before the issuance of this circular, hemodialysis solutions were registered under the classification of medical Device.
The exchange of ions in hemodialysis across a synthetic semipermeable membrane is a mechanical and biochemical process.
Dialysis solutions are used in the management of renal failure and poisoning; they allow the selective removal of toxic substances, electrolytes, and excessive body fluid from the blood.
The circular quotes Martindale The Extra Pharmacopeia 30th Edition on p. 851 to describe dialysis solutions.
Hemodialysis solutions supplement and replace the electrolytes required by the body while removing accumulated toxic substances and fluids which would normally be excreted by healthy kidneys.
The Bureau of Food and Drugs (BFAD) in the Philippines is the regulatory body that issued the circular.