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PKI Overview of Public Key Infrastructure (PKI) 1 Introduction The section provides an overview of Public Key Infrastructure. It is presented at this point in the Concept of Operations as an aid to
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It is proposed through the use of a PKI to provide a uniform electronic system for order management, and that will permit ordering of controlled substances and controlled substance prescription systems. 3 Design PKI is intended to provide consistency in the use of a person's personal identity number or a key to a persons' identity. The PKI provides some control over when and how a key is used to control the controlled substance. 4 Features PKI uses the public key cryptography of digital signatures to generate a user or key with which to control an individual's controlled substance (CDS). PKI uses the same encryption technology employed in cryptography for banking transactions. PKI provides the ability to encrypt digital information such as the drug's formulary. Public Key Infrastructure is a standard used in the security and encryption industries. In short, it is a method for encrypting key material that a system requires, such as digital certificates. 5 Public Key Infrastructure PKI is designed to operate in a manner to help assure that a person's identity is authentic and that it only contains data which could be used to identify that person's identity. PKI provides certain methods of data integrity that are not present in physical systems that do not utilize PKI. The following list describes some important features of PKI: 5.1 Key Distribution PKI requires a user or key to obtain a unique, public identification number. The system uses a variety of means for distributing the public key which protects the integrity and confidentiality of each user's credential. Each user's public key is divided into 10,000,000,000 key shares. A key share is a fixed size value derived using a shared secret algorithm. A key copy is similar to a public key, in that it contains a single, public key. PKI requires the use of keys to be distributed throughout the system in such a manner that each user has an equal amount of the necessary share of keys. Key distribution is intended to assure that each user's credentials are authentic and are stored independently of the other users' data, so that the keys are not readily usable as access codes. PKI protects the use of the public keys by making each user sign each public key. 5.2 Security and Encryption PKI provides secure operations and a system in which data is not exposed to malicious systems that would be able to decrypt it. PKI utilizes encryption algorithms and data security controls to provide secure operations.

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DEAECOM stands for Drug Enforcement Administration Electronic Order Compliance System. It is an electronic reporting system that allows registrants to submit their order and transaction information to the Drug Enforcement Administration (DEA) in compliance with the Controlled Substances Act.
Registrants who are authorized to handle controlled substances and are registered with the DEA are required to file deaecom. This includes manufacturers, distributors, research laboratories, pharmacies, hospitals, and practitioners.
DEAECOM is filled out electronically through the DEA's online reporting system. Registrants must log in using their DEA number and complete the required fields to report their order and transaction information. Detailed instructions and guidance can be found on the DEA's website.
The purpose of deaecom is to enable the DEA to monitor the distribution of controlled substances and ensure compliance with the Controlled Substances Act. It helps track and identify suspicious orders, prevent diversion, and ensure the secure and legitimate supply chain of controlled substances.
Registrants must report information such as the name and address of the supplier, the name and address of the customer, the drug name, strength, quantity, date of the transaction, and other relevant details. The specific information required may vary depending on the type and classification of the controlled substance.
The deadline to file deaecom in 2023 has not been specified. Registrants should refer to the DEA's official communication and website for the latest deadline information.
Penalties for the late filing of deaecom vary depending on the circumstances and jurisdiction. In general, late filings may result in administrative sanctions, fines, or other penalties imposed by the DEA. It is important for registrants to comply with filing deadlines to avoid potential penalties.
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