In March, the FDA released the FDA Memorandum Circular 2020-001 in response to the increasing demand for sanitising products.
It detailed regulatory guidelines in for local manufacturers looking to temporarily produce all ethanol and isopropanol products, regardless of concentration, intended for us as sanitising, antibacterial and antiseptic agents.
The Centre for Cosmetic Regulation and Research (CCRR) was tasked to facilitate the process.
The FDA has published a guide detailing the mandatory cosmetic labelling guidelines for sanitising products.
According to the FDA, hand sanitisers must include product name and function “to identify the product and guide you on intended use”, while brands names and logos are optional.
Labels must also note the net content, country of manufacture and include the manufacturing, expiry or best before date of the product.
Instructions of use must be included to inform of the proper usage of the product in terms of “application and frequency of use”.
Additionally, manufacturers need to include special precautions to inform users of conditions of use, warnings and note the use of ingredients from animal origin.
A full ingredient list should be displayed, including perfume, fragrance, aroma, flavour, colouring or botanical extracts.
Lastly, the product must be marked with the name and address of the manufacturer or distributor.
According to the memorandum, companies must submit complete labelling visuals in Filipino or English in a .png format.
For products that have already been notified as cosmetic products, the FDA states that they have to follow the labelling guidelines under the ASEAN Cosmetic Directive (ACD).
These products will be subjected to post-marketing surveillance activities, the FDA warned. “Applicable regulatory tools shall be implemented to non-compliant and violative products.”
Boosting hand sanitiser production
Previously, the FDA had issued a notice allowing licensed retail drug outlets such as pharmacies and drugstores to produce their own alcohol-based hand sanitisers to keep up with demand in the market.
The process can only be performed by a registered and licensed pharmacist that is employed by a licensed retail drug outlet.
While compounding hand sanitisers, the pharmacist must be wearing personnel protective equipment (PPE).
The FDA noted that the process must be conducted in a designated area for compounding that is well-sanitised and well-ventilated and has appropriate measures in place against fire hazards.
All sanitisers must be made using pharmaceutical-grade ingredients and must contain either 80% ethanol or 75% isopropyl alcohol.
The formula also must contain 1.45% glycerol and 0.125% hydrogen peroxide.
The circular stated that only distilled, filtered, or reverse osmosis water can be used in the mixture.
However, the FDA noted that it “strongly discourages” the addition of other ingredients such as fragrances and gelling agents as the agency said it could impact the quality and potency of the product.
Production is capped at 50 litres per batch and drugstores must record its formulations and imposed quality control measures for the products.