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7272 Wisconsin Avenue Bethesda, Maryland 20814 3016573000 Fax: 3016648877 www.ashp.org April 21, 2014, Food and Drug Administration Office of the Commissioner Division of Dockets Management (HFA305)
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How to fill out accurate tracking of drugs

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How to fill out accurate tracking of drugs:

01
Collect all necessary information: Start by gathering all relevant data about the drugs being tracked, such as the drug name, strength, dosage form, lot number, expiration date, and manufacturer details.
02
Use a standardized tracking system: Utilize a standardized system or software specifically designed for tracking drugs accurately. This could include barcode scanners, electronic health records, or other digital platforms that facilitate easy and efficient tracking.
03
Ensure proper labeling: Each drug should have a clear and legible label that includes all required information. This includes the drug's name, strength, dosage instructions, and any other necessary warnings or precautions.
04
Record every transaction: Every time a drug is received, dispensed, or transferred, it should be documented in the tracking system. This includes recording the date, time, quantity, and individuals involved in the transaction. This helps maintain a comprehensive and accurate record of the drug's movements.
05
Implement regular inventory checks: Conduct frequent inventory checks to reconcile the physical drug count with the data in the tracking system. This helps identify any discrepancies or potential issues in a timely manner.
06
Provide adequate training: Ensure that all personnel involved in drug tracking are adequately trained on the proper procedures, system usage, and any legal or regulatory requirements. This helps minimize errors and fosters a culture of accuracy and compliance.

Who needs accurate tracking of drugs:

01
Pharmacy and healthcare organizations: Accurate drug tracking is crucial for pharmacies and healthcare organizations to ensure patient safety, optimize inventory management, and comply with regulatory requirements.
02
Regulatory authorities: Government agencies and regulatory bodies need accurate drug tracking to monitor and enforce compliance within the pharmaceutical industry. This helps ensure that drugs are manufactured, distributed, and used in a safe and controlled manner.
03
Patients: Accurate drug tracking provides patients with assurance that the medications they receive are genuine, safe, and within the appropriate expiration dates. It also helps prevent counterfeit drugs from entering the supply chain, enhancing patient safety.
04
Manufacturers and distributors: Accurate tracking of drugs is essential for manufacturers and distributors to manage their inventory, prevent loss or theft, and maintain compliance with regulations. It enables efficient supply chain management and ensures the availability of quality products.
05
Healthcare professionals: Doctors, nurses, and other healthcare professionals rely on accurate drug tracking to ensure they are prescribing and administering the correct medications to their patients. It helps prevent errors, enhances patient care, and promotes patient outcomes.
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Accurate tracking of drugs is the process of monitoring and documenting the movement of pharmaceutical products from manufacturer to end user to ensure safety and prevent counterfeit or illegal drugs from entering the supply chain.
Manufacturers, distributors, repackagers, and dispensers are required to file accurate tracking of drugs in accordance with regulations set forth by the FDA and other regulatory bodies.
Accurate tracking of drugs can be filled out using electronic systems such as track and trace software, where information about the drug, its movement, and any parties involved in the supply chain are recorded and reported.
The purpose of accurate tracking of drugs is to ensure patient safety, prevent counterfeit drugs from entering the market, and comply with regulatory requirements to maintain the integrity of the pharmaceutical supply chain.
Information such as the product's serial number, expiration date, lot number, transaction history, and the names and locations of parties involved in the supply chain must be reported on accurate tracking of drugs.
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