So what products are included under the umbrella of DSCSA? This is a question we are often asked by our clients, particularly when a product is received without T3 documentation.  This article should quickly summarize for you what the key terms and the categories of drugs that are excluded (exempt) from DSCSA tracking requirements.

Two Key Terms: Product and Transaction

The two key terms you must understand are product and transaction. According to the Food, Drug, and Cosmetic Act (FD&C), a product is defined as:

… a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution)…

And according to the FD&C, transaction is defined as:

…transfer of product between persons in which a change of ownership occurs..

Lists of Exemptions to Product and Transaction Definitions

There are several exemptions to DSCSA regulations. These are fall into 2 basic categories: 1) Product Exemptions; 2) Transfer Exemptions.

Product Exemptions

The following is a list of products that are exempt from DSCSA track and trace requirements at this time:

  • Over the counter (OTC) products (Tylenol, hydrocortisone creams, anti-histamines, etc.)
  • blood and blood components intended for transfusion (Blood, Plasma, etc.)
  • radioactive drugs and radioactive biologics (“Radionuclides” such as Technetium-99).
  • imaging drug (MRI/CT/PET agents).
  • intravenous products (Saline, LR, Dextrose, Dialysates, Aminoysn, etc.)
  • medical gas (Nitrous Oxide, Oxygen, etc.)
  • compounded drugs (Finished Product and products used for compounding such as bulk powders).
  • medical convenience kits and combination products
  • sterile water and products intended for irrigation.
  • veterinary drugs
Transfer Exemptions (Non-Transactions)

The following transfer of ownership scenarios are not considered DSCSA transactions under the current law. These do not require the transfer of track and trace information (T3).

  • Dispensing drugs pursuant to a prescription to fulfill a “specific patient need” for an identified patient.
  • Intracompany distribution of any product between members of an affiliate or within a manufacturer
  • Distribution of a product among hospitals or other health care entities that are under common control
  • Distribution of product for Public Health Emergencies
  • Manufacturer Product Samples
  • Minimal quantities dispensed by a Retail Pharmacy to a Physician clinic for office use.
  • Sale, purchase, or trade to an IRS defined charitable organization.
  • Saleable and Non-Saleable Returns

If you have questions regarding whether a product is exempt, or a specific scenario is exempt, please contact us.