The Prescription Drug Marketing Act (PDMA) of 1987 is a federal law enacted to ensure the safety and effectiveness of prescription drugs by establishing strong regulatory controls against the sale of counterfeit, adulterated, misbranded, sub-potent, and expired drugs. In the context of drug sampling, the PDMA requires pharmaceutical companies to maintain records of drug samples distributed, implement accounting and auditing/monitoring policies, and comply with the regulations governing the distribution and handling of prescription drug samples.
What is 21 CFR Part 11, and why is it important for pharmaceutical companies?Kristen Anderson2023-04-29T16:32:59+00:00
21 CFR Part 11 is a regulation set forth by the FDA that outlines the criteria for electronic records and electronic signatures to be considered as reliable, trustworthy, and equivalent to paper records and handwritten signatures. This regulation applies to all FDA-regulated industries, including pharmaceutical companies, and is important for ensuring the integrity, security, and authenticity of electronic records and signatures associated with drug sampling and other regulated activities.
How do PDMA and 21 CFR Part 11 work together in the context of drug sampling?Kristen Anderson2023-04-29T16:39:49+00:00
PDMA and 21 CFR Part 11 work together in the context of drug sampling by ensuring the integrity and traceability of drug samples throughout the supply chain. PDMA imposes requirements on pharmaceutical companies to maintain records of drug samples distributed and ensure compliance with the regulations. Meanwhile, 21 CFR Part 11 addresses the criteria for electronic records and signatures to be considered as valid and reliable. By complying with both PDMA and 21 CFR Part 11, pharmaceutical companies can effectively manage their drug sampling processes and maintain high standards of accountability and traceability.
What are the key requirements of PDMA for drug sampling?Kristen Anderson2023-04-30T20:52:32+00:00
Pharmaceutical companies can ensure compliance with both PDMA and 21 CFR Part 11 by:
Developing and implementing clear internal policies and procedures for drug sampling
Employing electronic systems that adhere to 21 CFR Part 11 requirements for electronic records and signatures
Regularly monitoring and auditing sampling activities to ensure compliance with PDMA and other relevant regulations
Running downstream data analytics to identify red flags and worrisome trends in sampling data
Engaging in proactive vendor management when outsourcing drug sampling activities, ensuring that vendors follow the company’s policies and adhere to PDMA and 21 CFR Part 11 requirements
By maintaining compliance with both PDMA and 21 CFR Part 11, pharmaceutical companies can uphold the highest standards of accountability, traceability, and data integrity in their drug sampling processes.
What penalties can pharmaceutical companies face for non-compliance with PDMA and 21 CFR Part 11?Kristen Anderson2023-04-30T20:46:14+00:00