Are compounded medicines legal in the Philippines? What the Pharmacy Act says

This page reports what Philippine laws and FDA Philippines issuances say about compounding, quoting each one and naming its source. It is not legal advice.

What counts as compounding under Philippine law?

Compounding is drug preparation done by a pharmacist. The Philippine Pharmacy Act, Republic Act No. 10918, defines it in Sec. 5(g):

"(g) Compounding refers to the sum of processes performed by a pharmacist in drug preparation including the calculations, mixing, assembling, packaging, or labeling of a drug: (i) as the result of a prescription or drug order by a physician, dentist, or veterinarian; or (ii) for the purpose of, or in relation to, research, teaching, or chemical analysis;"

So the law names two bases for compounding:

• A prescription or drug order from a physician, dentist or veterinarian.
• Research, teaching or chemical analysis.

The same law, in Sec. 5(ii), defines pharmaceutical outlets as licensed entities "involved in compounding and/or dispensing and selling of pharmaceutical products directly to patients or end-users".

Who may compound medicines, and where?

Only licensed pharmacists may compound, and only through an outlet licensed by FDA Philippines. Four sections of RA 10918 set this out.

Sec. 4: a task for licensed pharmacists

Sec. 4 lists what the practice of pharmacy covers. Paragraph (a) reads: "Prepare, compound or manufacture, preserve, store, distribute, procure, sell, or dispense, or both, any pharmaceutical product or its raw materials". The section then says: "Activities under paragraphs (a), (b), (c), (d) and (i) are exclusive to licensed pharmacists."

Sec. 30: a licensed outlet and set standards

Sec. 30 says where compounding may happen:

"No pharmaceutical product, of whatever nature and kind, shall be compounded, dispensed, sold or resold, or otherwise be made available to the consuming public, except through a retail drug outlet duly licensed by the FDA."

It also says how, and gives the pharmacist a right to refuse:

"Compounding and dispensing shall be done only by duly registered and licensed pharmacists, in accordance with current Good Manufacturing Practice, laboratory practice, Philippine Practice Standards for Pharmacists and dispensing guidelines. A registered and licensed pharmacist may refuse to compound, dispense or sell drugs and pharmaceutical products, if not in accordance with this Act and the abovementioned standards."

DOH Administrative Order No. 2024-0015 (Section VI.A.1.d), the FDA Philippines licensing rules, says the same about outlets: "Only Pharmaceutical outlet licensed or authorized by the FDA shall compound, sell, offer for sale, or dispense any pharmaceutical product to the consuming public." FDA Philippines published this order as a scanned PDF, and the quote was read from that scan. The order lists drugstores, community or institutional pharmacies and boticas among the pharmaceutical outlets it covers.

Sec. 33: prescriptions

Sec. 33 reads: "All prescriptions and pharmacist-only OTC medicines shall be filled, compounded and dispensed only by a registered and licensed pharmacist, in accordance with the Philippine Practice Standards for Pharmacists, Dispensing Guidelines and other standards pertaining to purity, safety and quality."

It also says: "Prescription medicines may be dispensed only by a duly registered and licensed pharmacist and only with a valid prescription of a physician, dentist, or veterinarian."

Sec. 36: the label

A medicine compounded on a prescription is labelled for a named patient. Sec. 36 says every box, bottle or package of medicines "compounded or dispensed by a registered and licensed pharmacist based on prescription" must carry a label bearing, among others:

• the name of the patient and the generic name of the drug;
• the brand name, if any, strength, expiry date and directions for use;
• the name and address of the pharmacy;
• the name of the doctor and the dispensing pharmacist.

How is compounding different from manufacturing?

Two laws define a manufacturer, and both leave the compounding and filling of prescriptions in pharmacies out of that definition.

The full RA 10918 text reads:

"(gg) Pharmaceutical manufacturers refer to establishments engaged in any or all operations involved in the production of pharmaceutical products including the preparation, processing, compounding, formulating, filling, packaging, repackaging, altering, ornamenting, finishing and labeling, preparatory to their storage, sale, or distribution, except the compounding and filling of prescriptions in pharmaceutical outlets;"

The RA 9711 text, as published on Lawphil (spacing normalised), reads:

"'Manufacturer', in relation to a health product, means an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formnlating, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution: Provided, That the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies. A trader shall be categorized as a manufacturer."

("formnlating" is the spelling on Lawphil.) Annex A of DOH AO 2024-0015 repeats this definition. It is also a scanned PDF, and the quote was read from the scan.

RA 9711 Sec. 10 (amending Sec. 11(j) of RA 3720) prohibits "[t]he manufacture, importation, exportation, sale, offering for sale, distribution ... of any health product which, although requiring registration, is not registered" with the FDA. The manufacturer definitions above do not say that compounded prescriptions are exempt from product registration, and no FDA Philippines issuance on that point was found.

Large quantities

RA 10918 Sec. 45(k) makes it an offence to engage in:

"(k) Preparing and compounding of pharmaceutical products in quantities greatly in excess of single therapeutic doses, without the presence and supervision of a duly registered and licensed pharmacist;"

This section requires a pharmacist's presence and supervision. It does not set a numeric limit on quantity.

What are the penalties for compounding outside the rules?

RA 10918 Sec. 45 lists punishable acts. Two concern how compounding is carried out:

• Sec. 45(g): "Compounding and dispensing not in accordance with current Good Manufacturing Practice, Good Laboratory Practice and Philippine Practice Standards for Pharmacists, and such other standards and guidelines issued by the Board;"
• Sec. 45(k): compounding quantities greatly in excess of single therapeutic doses without a licensed pharmacist's presence and supervision (quoted above).

On conviction, Sec. 45 sets a fine of not less than two hundred fifty thousand pesos and not more than five hundred thousand pesos, or imprisonment of not less than one year and one day and not more than six years, or both.

How do FDA advisories on "compounded" and "research" products relate to pharmacy compounding?

RA 10918 Sec. 5(g) defines compounding as preparation by a pharmacist, and Sec. 30 requires it to go through a retail drug outlet licensed by the FDA. Separately, FDA Philippines has warned against products labelled "Compounded in USA" or "For research only" that have no Certificate of Product Registration.

What FDA Philippines advisories say

Advisory No. 2026-1306 opens: "The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug product: 1. ZMZ Peptides Tirzepatide Compounded in USA For subcutaneous use". It concerns an imported, unregistered product. It is not a statement about pharmacy compounding in the Philippines.

Advisory No. 2026-1309 treated a vial labelled "For research only" as an unregistered drug product. No FDA Philippines issuance defining "research use only" labels was found. For more on registration and research labels, see Are peptides legal in the Philippines?

What the US FDA says about compounded GLP-1s

The US FDA has made several statements on compounded GLP-1 medicines. They describe the US legal framework (sections 503A and 503B of the US Food, Drug, and Cosmetic Act), not Philippine law.

• Not approved: "compounded drugs are not FDA approved. This means the agency does not review compounded drugs for safety, effectiveness or quality before they are marketed."
• When to use them: compounded drugs "should only be used in patients whose medical needs cannot be met by an FDA-approved drug."
• Shortages over: FDA said the tirzepatide injection shortage was resolved (December 19, 2024) and the semaglutide injection shortage was resolved (February 21, 2025). Its update of April 1, 2026 says: "Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA's drug shortage list."
• Dosing errors: FDA received adverse event reports, some needing hospital care, that may be related to dosing errors with compounded injectable semaglutide, where patients measured the wrong dose and some health care professionals miscalculated doses.
• Salt forms: semaglutide sodium and semaglutide acetate "are different active ingredients than are used in the approved drugs", and FDA is "not aware of any lawful basis for their use in compounding."
• Fraudulent labels: FDA reports fraudulent compounded semaglutide with false label information, and fraudulent compounded tirzepatide whose labels name pharmacies that do not exist or that did not make the product. It has also warned companies selling unapproved semaglutide and tirzepatide falsely labelled "for research purposes" or "not for human consumption".

US FDA adverse event reports, as of May 31, 2026:

FDA notes these events are likely underreported, because US state-licensed pharmacies that are not outsourcing facilities are not required to report them.

Compounded is not the same as the branded medicines

Compounded semaglutide is a compounded preparation and is not the same product as Ozempic, Wegovy or Rybelsus. Compounded tirzepatide is not the same product as Mounjaro or Zepbound.

Trial results for the brands, such as those on the semaglutide and tirzepatide pages, are not results for compounded versions.

Has FDA Philippines said anything about compounded GLP-1s?

No FDA Philippines statement specifically about semaglutide or tirzepatide compounded by Philippine pharmacies was found.

A search of fda.gov.ph for "compounded" on October 7, 2026 returned only Advisory No. 2026-1306 and its Filipino version (2026-1306-A). Searches for "compounding", "extemporaneous" and "semaglutide" returned no statement on GLP-1 compounding.

Questions to ask your doctor or pharmacist

These are questions only. The answers depend on your doctor, your pharmacist and the product.

• Is the pharmacy licensed by FDA Philippines? FDA Philippines says its Verification Portal (verification.fda.gov.ph) can be used to check FDA-licensed establishments as well as registered products.
• Will a licensed pharmacist prepare the medicine on my doctor's prescription?
• Will the label show my name, the generic name and strength, the expiry date, directions for use, the pharmacy's name and address, my doctor and the dispensing pharmacist?
• Is this product the same as Ozempic, Wegovy, Mounjaro or Zepbound, or a compounded preparation?
• Is the product imported, or labelled "research use only" or "not for human consumption"?
• Which form of the active ingredient is used?
• How should I store it, and how long can I use it after opening?

FDA Philippines asks the public to report suspected unregistered or counterfeit health products, and unlicensed establishments, to ereport@fda.gov.ph or through its e-Sumbong platform on www.fda.gov.ph.