Pharmaceutical imports into the US are subject to close scrutiny by federal agencies, primarily the Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP). When ordering medications from abroad, understanding how these agencies operate is critical. Pharmacy Mall provides an overview based on regulatory practices, common enforcement patterns, and practical experience with cross-border shipments.

What US Law Says About Personal Drug Importation

Under Section 801 of the Federal Food, Drug, and Cosmetic Act (FDCA), it’s illegal to import unapproved prescription drugs into the US. That includes most medications purchased from other countries, even if they are approved for use in the US under a different brand name. The FDA does not recognize foreign approvals as equivalent.

However, the FDA has a discretionary policy that allows individuals to import a 90-day supply of a drug for personal use if:

  • The drug is not approved in the US but is used to treat a serious condition
  • There’s no effective treatment available domestically
  • The drug doesn’t pose an unreasonable risk
  • The person importing the drug affirms in writing it’s for personal use
  • The medication is shipped directly to the patient, not for resale

This policy does not guarantee release. CBP has the authority to detain, inspect, and reject any package, even when personal-use criteria are met. And if a product violates the Controlled Substances Act or involves narcotics or stimulants, it will be seized.

Customs Flags and What Triggers Seizures

CBP screens packages using data patterns and AI-assisted profiling. Shipments coming from high-volume pharmaceutical exporters are often flagged for secondary inspection. This includes many countries in South Asia and Eastern Europe, but also Canada when drugs are clearly labeled as prescription medications.

Common seizure triggers include:

  • Bulk shipments with multiple packages under one name
  • Packaging that lists pharmaceutical contents on the exterior
  • Medications that are Schedule II–IV controlled substances
  • Items declared as “dietary supplements” but recognized as prescription drugs in the US
  • Shipments lacking prescription documentation or medical justification

CBP does not always notify the customer when a package is detained. In some cases, an FDA Notice of Action is sent, requiring a formal response. If the product is deemed non-admissible, it will be destroyed or returned to sender.

How Pharmacy Mall Addresses US Import Risk

We ensure that all medications are packaged discreetly, with no external labeling that would indicate prescription content. Our shipments are routed through countries with established export cooperation with the US and are limited to personal-use quantities.

Each shipment:

  • Contains no more than a 90-day supply
  • Is not a controlled substance under US federal law
  • Is labeled in accordance with WHO standards
  • Is shipped with documentation when necessary, including patient declarations

We follow product selection guidelines based on FDA import history. Drugs most commonly admitted into the country without issue are prioritized. These include generics that match the FDA’s Orange Book listings and formulations available in the US market under different brand names.

What Customers Can Do to Reduce Risk

  1. Order smaller quantities, ideally under the 90-day threshold.
  2. Do not order controlled substances, stimulants, or opioids from abroad.
  3. Avoid large combined orders with multiple medications in one box.
  4. If contacted by CBP or FDA, respond promptly with documentation showing medical necessity and personal use.

Import laws are strict but enforcement varies. Personal-use discretion does exist, but there are no guarantees. Pharmacy Mall operates with awareness of historical patterns and tailors shipping to reduce friction with customs processes.

Note on Insurance and Reshipments

Because international pharmacy orders fall outside US insurance frameworks, confiscated or rejected shipments are not eligible for reimbursement from health insurers. In the event of a seizure, we may offer one reshipment per order depending on the case, but repeated violations often result in permanent delivery blocks by CBP.

Each import is ultimately at the discretion of federal authorities. Pharmacy Mall aligns with international standards and uses compliance-informed logistics to help medications reach US customers as smoothly as possible.