How Philippine hospitals and licensed facilities can verify an injectable supplier: Food and Drug Administration (FDA) verification portal, Certificate of Product Registration (CPR) number, License to Operate (LTO), authorization letter and batch documents

In short: checking an injectable supplier is a sequence of document checks, each made against an independent source and not against copies the supplier sends. The layers are the supplier's License to Operate (LTO), the product's Certificate of Product Registration (CPR), the authorization that links the supplier to the registrant, the papers for the delivered batch, and the record of storage and transport. A gap in any layer is a reason to stop and ask before the product is received.

This article is for procurement officers, pharmacists in charge and licensing staff at hospitals and licensed healthcare facilities. It describes checks that follow from the structure of Philippine drug regulation, as set out in our companion article on the License to Operate and the Certificate of Product Registration. We write both terms, and the Food and Drug Administration (FDA) Philippines, in full where they first appear.

Most of the checks below are good purchasing practice. Where a check rests on a legal text or an FDA document we say which one, and where we rely on a consultancy guide we say that too. Several FDA web pages could not be retrieved by our tools, so the description of the FDA's online verification portal comes from secondary sources. Nothing here assesses any supplier or product.

The two numbers on every set of papers

A supplier's papers carry two different kinds of number, and each answers a different question. The License to Operate belongs to an establishment and names the activities it may carry out. The Certificate of Product Registration belongs to one product and names the registrant. Republic Act 9711 prohibits manufacturing, importing, exporting, selling, distributing or retailing a drug without the license the Act requires, and it separately prohibits offering a health product that needs registration and is not registered. The buyer's job is to check both, and then to check that they belong together.

A product registration does not make every company holding stock a licensed supplier. The FDA's licensing sheets list separate establishment categories, among them drug trader, drug distributor (importer, exporter, wholesaler), drugstore and retail outlet for non-prescription drugs. A buyer should confirm that the category on the supplier's license matches what the supplier is doing in the transaction.

Checking the registration

The FDA runs an online verification portal for registered products. Consultancy guides describe a search by product name or by registration number, and one reports that an FDA circular of 2023 required the approved package insert of registered drug products to be published there. We could not confirm the current interface from an FDA page, and for that reason we give no link. Open the portal from the FDA's own website, and never from an address that a supplier sends you.

A useful routine has four steps. Search by the generic name as well as the brand name. Compare every field of the entry with the label of the product offered: generic name, brand name, strength, dosage form and presentation. Read the validity dates, since a registration that has expired is not a current registration. Save a dated printout or screenshot of the entry for the procurement file.

If the product does not appear, that is not by itself proof that it is unregistered, because naming and spelling differ. It is a reason to hold the purchase until the supplier explains the gap and the FDA confirms the status. A copy of a certificate supplied by a seller is a claim. The portal entry and the FDA's own confirmation are the evidence.

Checking the establishment

Ask for a copy of the supplier's License to Operate and compare it with the name and address on the invoice, the delivery note and the registration. The FDA's service sheet for the initial license asks for proof of business registration, a location plan with GPS coordinates and a named qualified person, so each of these facts exists on file at the FDA. Where the FDA offers a lookup for establishments, use it. Where it does not, confirm the details with the FDA directly and keep the reply.

The buyer's own side has its own license. Republic Act 4226, the Hospital Licensure Act, provides that a hospital may not operate or be opened to the public unless it has been registered and has obtained a license from the licensing agency, and later Department of Health orders set the classification and licensing details. That license is separate from the supplier's, and one does not replace the other.

The link between supplier and registrant

The product registration names a registrant. The supplier in front of you may be that registrant or may be another licensed company that handles the product. The authorization chain ties the two together, and it is the layer most often left unchecked.

Read the letter for the same things in every case: who signs, on whose letterhead, which products it names, which period it covers and what activity it permits. An authorization that names no products, carries no date or cannot be confirmed by the signing company should be treated as missing.

The papers for each batch

Registration and licensing describe the product and the company in general. Each delivery then needs its own evidence that the units in the box are the registered product and that they were kept in the right conditions. The checks below apply to every batch received.

At receiving, check that seals are intact, that the lot number and expiry date on every carton match the certificate, and that the quantity matches the delivery note. Keep the certificate with the batch record, so that a later question about a vial can be traced to the delivery.

Warning signs

Some patterns justify stopping a purchase until the supplier has answered in writing:

• No License to Operate number, or a license for a different activity than the one being carried out.
• A registration whose registrant is a different company, with no authorization letter.
• A product name, strength or presentation on the box that differs from the registration entry.
• Documents offered only as images that cannot be traced to an issuing body.
• A request to skip a check because a delivery is urgent.
• A promise to complete registration or authorization after delivery.

The FDA has repeatedly issued public advisories about unregistered health products. We could not retrieve those pages in full, so we do not summarize their content, but they are a reason to regard any gap in the layers above as serious.

Keeping a verification file

A verification file turns a one-off check into something an auditor or a licensing officer can follow. For each supplier keep the dated copy of the license, the dated portal record for each product, the authorization letters and the correspondence that confirmed them. For each batch keep the certificate, the delivery note and the storage record. Assign one named owner for the file and set a date to repeat the checks before any registration or license reaches its stated expiry. Because registrants may ask for validity of two years or five years, the expiry dates differ between products from the same supplier.

Scope of this article

This article describes document checks that follow from the structure of the licensing and registration rules. It does not assess any supplier or product, does not replace the Department of Health rules on a facility's own licensing, and does not replace advice from the FDA or from counsel. The legal texts we read were Republic Act 9711 (from the Lawphil project), Republic Act 4226 and the implementing rules of RA 9711 (from the WIPO copy), together with FDA service sheets uploaded in 2023.