Final answer:
The DEA requires a certification process for software to manage electronic prescriptions, ensuring the safe and effective electronic handling of prescriptions. This parallels the FDA's extensive drug approval process for new therapies, which must demonstrate safety and effectiveness through clinical trials.
Step-by-step explanation:
To obtain the DEA certification needed to transmit and receive electronic prescriptions, the DEA requires the software/application to undergo a certification process. This is part of ensuring that drugs are safely and effectively managed and prescribed. Before reaching this stage, any new therapy or drug develops through a meticulous process outlined by the FDA. After its initial synthesis by a chemist, the drug undergoes pre-clinical testing which includes laboratory data from animal trials. Following this, an Investigational New Drug (IND) application must be submitted and gave a 30-day review period by the FDA's Center for Drug Evaluation and Research (CDER).
If the IND is approved, human clinical trials can commence. Results from these trials regarding the drug's efficacy and safety are collected, which must meet the FDA standards before the developers submit a New Drug Application (NDA). This NDA includes details on the drug's manufacturing, packaging, monitoring, and administration. The New Drug Application (NDA) is a critical step in the process, ensuring that the drug is proven to be 'safe and effective when used as directed' before obtaining approval to be prescription-available. Similarly, the DEA's certification process for the software guarantees that the electronic handling of prescriptions aligns with regulatory standards for controlled substances.