QuestionsQuestions (BFAD BUREAU CIRCULAR NO. 04, S. 2000)
It implements Administrative Order No. 13, s. 1999 by directing BFAD Regional Food and Drug Regulation Officers to strictly follow the classification and dispensing rules for preparations containing hydroquinone and/or tretinoin.
Administrative Order No. 13, s. 1999, dated April 6, 1999, titled “Use of Hydroquinone and/or Tretinoin (Retinoic Acid).”
They are classified as a “Household Remedy,” allowed in any establishment but must be placed in a segregated area.
They are classified as an “Over-the-Counter (OTC) Drug,” to be sold in drug outlets without the need for a doctor’s prescription.
They are classified as “Prescription (Rx) Drugs,” and they may be dispensed by drug outlets only with a doctor’s prescription.
They are classified as a “Household Remedy,” allowed in any establishment but must be placed in a segregated area.
They are classified as an “Over-the-Counter (OTC) Drug,” dispensed in drug outlets without need for a doctor’s prescription.
They are classified as “Prescription (Rx) Drugs,” requiring a doctor’s prescription, and may be dispensed only in drug outlets.
It classifies the combination as a “Household Remedy,” allowed in any establishment but must be placed in a segregated area.
Any establishment, with the specific requirement that the product be placed in a segregated area.
They may be sold in drug outlets, and no doctor’s prescription is required.
They may be sold in drug outlets only, and they require a doctor’s prescription.
In the interest of public health and safety, it controls access to these substances in any establishment by requiring physical separation from other items.
They are directed to strictly implement the provisions of Administrative Order No. 13, s. 1999.
It was adopted on June 14, 2000 and signed by William D. Torres, Ph.D., as Director.
Compliance depends on the specific concentration of hydroquinone and/or tretinoin in the preparation, which determines whether it is classified as Household Remedy, OTC, or Rx and the required dispensing conditions.
It falls under “More than 2.0% but less than 3.0% hydroquinone,” thus it is an OTC drug that can be sold in drug outlets without a doctor’s prescription.
It falls under “More than 0.025% but less than or equal to 0.05% tretinoin,” making it an OTC drug dispensable in drug outlets without a doctor’s prescription.