Citing serious safety risks and possible violations of Philippine pharmaceutical laws, the Philippine College of Physicians (PCP) has warned the public against the growing promotion and use of compounded or non-FDA registered versions of semaglutide (Ozempic) and tirzepatide (Mounjaro).

In a public health advisory, the PCP cautioned patients, healthcare professionals, pharmacies, and regulators about the increasing sale of compounded or unregistered glucagon-like peptide-1 (GLP-1) receptor agonists, including compounded versions of semaglutide, originally marketed as Ozempic, and tirzepatide, sold under the brand name Mounjaro.

“While GLP-1–based therapies have demonstrated substantial benefits when approved by regulatory authorities and manufactured under strict pharmaceutical standards, compounded or unregistered formulations pose serious risks to patient safety and may violate existing Philippine laws governing pharmaceutical practice,” the PCP said.

Among the major concerns cited by the physicians’ group are incorrect dosing, inconsistent drug potency, and the possible use of untested chemical forms of semaglutide.

PCP noted that international pharmacovigilance reports have identified several dangers linked to compounded GLP-1 receptor agonists that have not undergone proper regulatory review.

These include “incorrect dosing or overdose, especially with multi-dose vials requiring manual measurement,” “inconsistent drug potency or concentration, leading to treatment failure or toxicity,” and the “use of untested chemical forms, including semaglutide salt preparations not evaluated in clinical trials.”

As such, the PCP warned about potential contamination risks and the proliferation of counterfeit or mislabelled medications being distributed through unregulated online sellers and telehealth vendors.

According to the group, compounded products differ from approved medicines because they have not undergone the rigorous clinical testing, manufacturing oversight, and regulatory evaluation mandated by the Food and Drug Administration (FDA).

“Unlike approved medicines, these compounded products have not undergone rigorous clinical trials, manufacturing oversight, or regulatory evaluation required by the Food and Drug Administration (FDA Philippines),” the advisory said.

The PCP also reminded pharmacies and clinics that the sale or dispensing of unregistered pharmaceutical products may violate the Pharmacy Law.

“The promotion, dispensing, or sale of unregistered pharmaceutical products violate provisions of Republic Act No. 10918, which regulates the practice of pharmacy in the Philippines,” it said.

It cited Republic Act No. 10918, or the Philippine Pharmacy Act, noting that dispensing or offering prescription medicines in establishments not licensed by the Food and Drug Administration (FDA) or without the supervision of a licensed pharmacist may constitute violations of the law.

The physicians’ group urged patients to avoid purchasing such medications, particularly those sold online or through unverified clinics.

“Do not purchase or use compounded or unregistered GLP-1 medications, especially those sold online or through unverified clinics,” the advisory stated.

Also, the PCP called on physicians to prescribe only FDA-approved therapies and educate patients about the risks of unregulated metabolic treatments.

“Do not prescribe or recommend compounded or unregistered GLP-1 receptor agonists,” it said.

Meanwhile, the organization urged regulators and law enforcement agencies to strengthen monitoring and enforcement against the illegal sale of compounded metabolic drugs.

“The Philippine College of Physicians respectfully calls upon Food and Drug Administration (FDA Philippines), Department of Health (DOH), Professional Regulation Commission (PRC), law enforcement and regulatory agencies to strengthen surveillance and enforcement against illegal compounded metabolic drugs,” the advisory stated.

The group stressed that ensuring access to safe and properly approved medicines is crucial to protecting public health.