Month: April 2018

Effectivity of the New Schedule of Fees

Please be informed that the Food and Drug Administration will be implementing its new schedule of fees effective 30 June 2018. Further, the Food and Drug Action Center (FDAC) will no longer accept cash payments starting on the same date. Instead, payments may be done through the following:

For specific details on the Collection Policy and Procedure, you may refer to FDA Circular 2017-010.

For more information and inquiries, please call the FDAC at (02) 821-1176 / (02) 821-1177. You may also e-mail us at [email protected].

Attachment: FDA Advisory No. 2018-117

Intensified Campaign Against Counterfeit Pharmaceutical Products

The FDA is again reminding the public to be more vigilant in buying drug products as it has noted that counterfeit pharmaceutical products have become prevalent in the local market. The FDA warns that counterfeit pharmaceutical products pose serious threat to public health and safety. Their effectivity is unverified and questionable. They may worsen illness and disease. They may cause serious adverse health consequences, another disease, drug resistance, or worst, death.

Counterfeit pharmaceutical products are those which either:

  • contain the wrong ingredient;
  • have no active ingredient; or
  • have the correct/active ingredients but in insufficient amount.

Often, counterfeit pharmaceutical products are usually deliberately and fraudulently mislabelled.

The FDA cites the all-out support of President Rodrigue Roa Duterte for the campaign to curtail the proliferation of fake drugs in the market. It sends a strong message that the government is serious in its fight against these counterfeit pharmaceutical products.

Through the Task Force D-PUNCH [Destroy Products Unfit for Consumption of Humans], the FDA is working closely with the Philippine National Police (PNP) in monitoring and investigating reports involving the activities of a number of unscrupulous manufacturers, distributors, traffickers and traders of counterfeit pharmaceutical products. Headed by PCSupt. Allen B. Bantolo (ret.), Task Force D-PUNCH is working towards the immediate arrest of these perpetrators for violation of Section 4 of Republic Act No. 8203 or the Special Law on Counterfeit Drugs and other related laws, rules and regulations.

The FDA seeks the help and cooperation of the Local Government Units (LGUs) and Law Enforcement Agencies (LEAs), the concerned establishments and the public in general to reduce, and eventually eradicate, counterfeit pharmaceutical products in the local market.
All (LGUs) and (LEAs) are requested to ensure that counterfeit pharmaceutical products, as posted in the FDA’s website, or as they may suspect to be counterfeit (for submission and verification by the FDA), are not sold or made available in their localities or areas of jurisdiction
All concerned establishments and outlets are also warned against selling and/or dispensing counterfeit pharmaceutical products as posted in the FDA’s website, or as they may suspect to be counterfeit (for submission and verification by the FDA).

The public is advised not to buy pharmaceutical products from establishments or online stores operating without the necessary government permits. The FDA urges the consuming public to purchase medicine and other health products only from government licensed pharmacies and make sure that they have the appropriate FDA marketing authorizations.
For more information and inquiries, please e-mail us at [email protected]
To report continuous sale or distribution of unregistered and/or counterfeit health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Previous Public Warnings:

  1. https://ww2.fda.gov.ph/attachments/article/474023/FDA-Anti-Fake-Meds.jpg
  2. https://ww2.fda.gov.ph/announcement/474982-fda-warns-vs-fake-products

Previous FDA Advisories:

  1. Sevoflurane (Sevorane) 100% Liquid for Inhalation
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/496196-fda-advisory-no-2018-082
  2. Paracetamol (Biogesic) 500 mg Tablet
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/496183-fda-advisory-no-2018-081
  3. Buclizine HCl + Multivitamins + Mineral (Propan with Iron) Capsule
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/495521-fda-advisory-no-2018-074
  4. Naproxen sodium (Flanax Forte) 550 mg Tablet
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/493500-fda-advisory-no-2018-073
  5. Tetanus Antitoxin (Antitet) 1500 I.U./0.7 mL Solution for Injection
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/492898-fda-advisory-no-2018-067
  6.  Dydrogesterone (Duphaston)  10 mg Film-coated Tablet
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/455254-fda-advisory-no-2017-243
  7. Mefenamic Acid (Dolfenal) 500 mg Tablet
    Dextromethorphan HBr + Phenylephrine HCI + Paracetamol (Tuseran Forte) 15 mg / 10 mg / 325 mg Capsule
    Loperamide (Diatabs) 2 mg Capsule
    Ibuprofen + Paracetamol (Alaxan FR) 200 mg / 325 mg Capsule
    Phenylephrine HCI / Chlorphenamine Maleate / Paracetamol (Neozep Forte) 10 mg / 2 mg / 500 mg Tablet
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/381228-fda-advisory-no-2016-141
  8.  Albumin (Human) U.S.P. Human Albumin Grifols 25% Solution “Manufactured by Instituto Grifols, S.A., Barcelona, Spain”
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/381222-fda-advisory-no-2016-140
  9. Tetanus Antitoxin (Antitet) 1500 IU/0.75 mL Solution for Injection (IM/IV/SC) and 3000 IU/0.95 mL Solution for Injection (IM/IV/SC)
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/350204-fda-advisory-no-2016-081
  10. Albumin (Human) (Albonorm 20%) 20 g / 100 mL at (Albonorm 25%) 25 g / 100 mL Solution
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/349249-fda-advisory-no-2016-079
  11.  Tetanus Antitoxin (Sharjvax) 1500 I.U. / 0.7 mL Solution for Injection and 3000 I.U. / 0 .95 mL Solution for Injection
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/345616-fda-advisory-no-2016-062
  12.  Falsified Hepatitis C Medicines circulating in South East Asia
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/334480-fda-advisory-no-2016-044-public-health-advisory-on-world-health-organization-s-medical-product-alert-no-3-2016-re-falsified-hepatitis-c-medicines-circulating-in-south-east-asia
  13.  Falsified Amaril Yellow Fever Vaccines Circulating in South East Asia
    https://ww2.fda.gov.ph/advisories-2/pharmaceutical-2/333611-fda-advisory-no-2016-036-public-health-advisory-on-world-health-organization-s-medical-product-alert-no-2-2016-re-falsified-amaril-yellow-fever-vaccines-circulating-in-south-east-asia