The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
What is the purpose of the DSCSA?
The DSCSA was created to strengthen the security of the drug distribution supply chain by adding controls such as a national pharmaceutical track and trace system and establishing national standards for licensing of prescription drug wholesale distributors and third-party logistics providers (3PLs).
What are the 2 parts of the Drug Quality and Security Act?
The Drug Quality and Security Act has two distinct and independent acts: 1) the Compounding Quality Act and 2) the Drug Supply Chain Security Act.
Why the DSCSA was enacted?
Congress enacted the DSCSA in 2013. The act was crafted in response to the danger to patient safety of counterfeit drugs entering the U.S. prescription drug supply chain. … Finally, the DSCSA establishes national licensure and licensing standards for drug wholesalers and third-party logistics providers.
Does DSCSA apply to medical devices?
If your product is a device—even if the FDA requires your device to be dispensed only with a physician-issued prescription (“Rx Only”)—then it is not a prescription drug and therefore it is not covered by the DSCSA. … Some devices are classified by the FDA as drug-device or biologic-device Combination Products (CPs).
What does DQSA stand for?
The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
What makes a drug adulterated?
A drug or device shall be deemed to be adulterated: (a) (1) If it consists in whole or in part of any filthy, putrid, decomposed substance; or (2) if it has been prepared, packed, or held under insanitary conditions contaminated with filth or whereby it may have been rendered injurious to health; or (3) if it is a drug …
What is the difference between 503A and 503B?
503A compounding complies with USP <797> standards and focuses on customized patient-specific compounding dispensed only with a prescription. … 503B compounding is essentially batch compounding with required compliance to the federal cGMP regulations including 100% release testing quality assurance.
What policies of drug security should the medical assistant be aware of?
A medical assistant must be aware of basic pharmacology including commonly prescribed medications, drug categories and classifications, drug schedules, side effects and adverse effects, measurement, mathematical conversions, and dosage calculations, common approved medical abbreviations, forms of medication, look-alike …
What products are exempt from Dscsa?
What Transactions are Considered Exempt from the DSCSA?
- An intravenous solution intended for the replenishment of fluids and electrolytes.
- A product intended to maintain the equilibrium of water and minerals in the body.
- A product intended for irrigation or reconstitution.
- An anesthetic.
- An anticoagulant.
- A vasopressor.
When was the Orphan Drug Act passed?
Congress passed the Orphan Drug Act of 1983 to stimulate the development of drugs for rare diseases. A rare disease is defined as a disease that affects fewer than 200,000 people in the United States.
What is the quality of a drug?
Where quality is defined as the degree to which a set of intrinsic properties of a drug product, its underpinning manufacturing process, and any supporting processes fulfils the pre-determined criteria.
What is drug serialization?
Serialization is the assigning of a unique serial number to each saleable unit of each prescription product, which is linked to information about the product’s origin, batch number and expiration date.