The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the President on April 22, 1988. The legislation was necessary to increase safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs.

Federal Food, Drug, and Cosmetic Act

The 1906 Pure Food and Drug Act and creation of the FDA In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the “Wiley Act” after its chief advocate.

More specifically, PDMA in part regulates the storage, handling and distribution of prescription drug samples by firms via mail, common carrier, and delivery by representatives to licensed practitioners or pharmacies of hospitals or other health care entities.

The Prescription Drug Marketing Act of 1987 (PDMA), amended by the Prescription Drug Amendments of 1992 (PDA), requires, among other things, that certain wholesalers provide a statement (also known as a pedigree) prior to each wholesale distribution of prescription drugs.

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

The Prescription Drug Marketing Act (PDMA), which has been in place since 1987, requires that drug manufacturers and distributors maintain records of the samples they distribute.

Only pharmacists, physicians, and advance practice providers with prescribing authority may dispense medications. When an office practice dispenses sample medications, it must follow state and federal pharmacy regulations.

You are only permitted to mail prescription drugs via the USPS if you are a pharmacist or medical provider mailing such drugs to the patient they have been prescribed to. This means that without proper medical licensing you can receive prescription drugs, but you cannot, under any circumstance, mail them.

FDA Allows Prescription Drug Samples To Be Mailed Directly To Patients.

performing telephone or in-person triage, assessing or diagnosing symptoms, prescribing medications or making recommendations about over-the-counter drugs and remedies, giving out drug samples without provider permission, automatically submitting refill prescription requests without provider orders, administering …

The answer is simple: only licensed professionals and as few of them as is reasonable. That trusted chairside auxiliary who has worked in the office for 5 years could be the person to ruin your practice if he or she is a drug abuser.

“Physicians and staff may not accept pharmaceutical samples for their own personal use or for distribution to patients or family members. Distributing sample drugs would place physicians in a drug dispensing role, subject to applicable laws and regulations.”

Some plans may require that you fill through a mail order pharmacy for fills of more than a 30-day supply. To switch to 90-day fills, note that you’ll need a new prescription from your doctor; a 30-day quantity prescription will not allow 90-day fills.