10.3 Prescription Drug Marketing Act (PDMA): Samples, Reimportation & Wholesale Distribution

10.3 Prescription Drug Marketing Act (PDMA): Samples, Reimportation & Wholesale Distribution

MPJE Core Concept: The Prescription Drug Marketing Act (PDMA) of 1987 (enacted as an amendment to the Federal Food, Drug, and Cosmetic Act) regulates the commercial distribution of prescription drugs to prevent drug diversion, adulteration, and counterfeiting. Key MPJE topics include the strict prohibition against retail pharmacies possessing drug samples, strict requirements for hospital sample distribution, the federal reimportation ban, and wholesale distributor licensing.

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Legislative Intent and Overview of PDMA

Congress passed the PDMA in 1987 in response to widespread evidence of a "secondary wholesale market" operating without adequate oversight. Unscrupulous entities were buying discounted institutional drugs, expired samples, and diverted products, repackaging them, and re-entering them into the commercial retail drug supply.

Core Objectives of the PDMA

1. Ban the Sale of Drug Samples: Eliminate commercial trade, sale, purchase, or offer to sell prescription drug samples.
2. Restrict Sample Possession: Completely prohibit retail community pharmacies from possessing prescription drug samples.
3. Control Reimportation: Ban the reimportation of U.S.-manufactured prescription drugs (American Goods Returned) except by the original manufacturer.
4. License Wholesalers: Establish state licensing standards for wholesale prescription drug distributors.
5. Restrict Resale by Healthcare Entities: Prohibit hospitals and health care entities from reselling drug purchases to retail pharmacies.

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Prescription Drug Samples: Strict Federal Controls

A prescription drug sample is defined under the PDMA as a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

+-----------------------------------------------------------------------------+
|                     RETAIL PHARMACY SAMPLE PROHIBITION                      |
|                                                                             |
|   RETAIL COMMUNITY PHARMACIES ARE STRICTLY PROHIBITED FROM POSSESSING,     |
|   RECEIVING, OR STORING PRESCRIPTION DRUG SAMPLES UNDER ANY CIRCUMSTANCES.  |
|                                                                             |
|   * Possession of even a single sample in a retail pharmacy is a violation   |
|     of federal law (FD&C Act / PDMA) and constitutes misbranding.          |
+-----------------------------------------------------------------------------+

Institutional & Hospital Pharmacy Sample Rules

While retail community pharmacies can never possess drug samples, institutional health-system pharmacies (e.g., hospital pharmacies) and licensed prescribers may receive and store drug samples under strict statutory conditions:

1. Written Request Required: Drug samples may only be distributed by a manufacturer or authorized distributor to a licensed practitioner (prescriber) or to a hospital/health care entity pharmacy pursuant to a written request signed by the licensed practitioner.
2. Written Request Elements: The written request must contain:
   • Name, address, professional title, and license number of the practitioner.
   • Name, strength, dosage form, and quantity of the sample requested.
   • Name of the manufacturer/distributor.
   • Date of the request and signature of the practitioner.
3. Standing Written Requests: Requests must be executed annually or per shipment; standing oral requests are illegal.
4. Receipt & Inventory Records: The institutional pharmacy must maintain receipt records, store samples separate from commercial inventory, and conduct annual physical inventories.

Starter Packs vs. Prescription Drug Samples

On the MPJE, candidates must distinguish between prescription drug samples and starter packs:

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Reimportation Restrictions (American Goods Returned)

The PDMA generally prohibits the reimportation of U.S.-manufactured prescription drugs that have been exported to foreign countries. This rule is often referred to as the "American Goods Returned" provision.

General Rule & Manufacturer Exception

• General Prohibition: No prescription drug manufactured in the United States that was exported may be reimported back into the U.S. by anyone other than the original manufacturer.
• Rationale: Once a drug leaves the regulated U.S. supply chain, the FDA cannot guarantee its storage conditions, temperature control, authenticity, or safety.

Personal Importation & Compassionate Use (FDA Guidance)

Under strict FDA enforcement discretion, individuals may personally import small quantities of unapproved foreign drugs for personal use under the Compassionate Use Exemption, provided ALL of the following criteria are met:

1. The drug is for a serious condition for which effective treatment is not available domestically.
2. There is no commercialization or promotion of the drug to U.S. residents.
3. The drug does not represent an unreasonable health risk.
4. The individual provides the name and address of the licensed U.S. physician treating them.
5. The quantity imported does not exceed a 90-day supply.

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Wholesale Distributor Licensing & Resale Restrictions

The PDMA prohibits hospitals, health systems, and charitable health care entities from reselling or transferring prescription drugs to retail community pharmacies. This prevents arbitrage where non-profit institutions buy drugs at steep preferential discounts and flip them to retail entities for profit.

Exceptions to Hospital Resale Prohibition

1. Intracompany Sales: Transfers between hospitals or healthcare entities under common control.
2. Emergency Medical Reasons: Emergency transfers to a retail pharmacy or distributor to alleviate a temporary localized shortage.
3. Group Purchasing Organizations (GPOs): Purchases made through a GPO for the institution's own use.
4. Outpatient Dispensing: Dispensing drugs pursuant to prescriptions to hospital employees, retirees, or bona fide outpatient clinic patients.

Wholesale Licensing & NABP Accreditation (VAWD)

• State Licensing: All wholesale distributors must be licensed by the state in which they reside and every state into which they ship prescription drugs.
• NABP Drug Distributor Accreditation: Formerly known as VAWD (Verified-Accredited Wholesale Distributors), this accreditation verifies that wholesale facilities meet rigorous facility security, background check, storage control, and DSCSA compliance standards.

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Comparative Matrix: PDMA vs. DSCSA Standards