[Federal Register Volume 77, Number 185 (Monday, September 24, 2012)]
[Rules and Regulations]
[Pages 58767-58769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23529]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1300


Definitions Relating to Electronic Orders and Prescriptions for 
Controlled Substances

CFR Correction

    In Title 21 of the Code of Federal Regulations, Part 1300 to End, 
revised as of April 1, 2012, on page 14, Sec.  1300.03 is reinstated to 
read as follows:


Sec.  1300.03  Definitions relating to electronic orders for controlled 
substances and electronic prescriptions for controlled substances.

    For the purposes of this chapter, the following terms shall have 
the meanings specified:
    Application service provider means an entity that sells electronic 
prescription or pharmacy applications as a hosted service, where the 
entity controls access to the application and maintains the software 
and records on its servers.
    Audit trail means a record showing who has accessed an information 
technology application and what operations the user performed during a 
given period.
    Authentication means verifying the identity of the user as a 
prerequisite to allowing access to the information application.
    Authentication protocol means a well specified message exchange 
process that verifies possession of a token to remotely authenticate a 
person to an application.
    Biometric authentication means authentication based on measurement 
of the individual's physical features or repeatable actions where those 
features or actions are both distinctive to the individual and 
measurable.
    Biometric subsystem means the hardware and software used to 
capture, store, and compare biometric data. The biometric subsystem may 
be part of a larger application. The biometric subsystem is an 
automated system capable of:
    (1) Capturing a biometric sample from an end user.
    (2) Extracting and processing the biometric data from that sample.
    (3) Storing the extracted information in a database.
    (4) Comparing the biometric data with data contained in one or more 
reference databases.
    (5) Determining how well the stored data matches the newly captured 
data and indicating whether an identification or verification of 
identity has been achieved.
    Cache means to download and store information on a local server or 
hard drive.
    Certificate policy means a named set of rules that sets forth the 
applicability of the specific digital certificate to a particular 
community or class of application with common security requirements.
    Certificate revocation list (CRL) means a list of revoked, but 
unexpired certificates issued by a certification authority.
    Certification authority (CA) means an organization that is 
responsible for verifying the identity of applicants, authorizing and 
issuing a digital certificate, maintaining a directory of public keys, 
and maintaining a Certificate Revocation List.
    Certified information systems auditor (CISA) means an individual 
who has been certified by the Information Systems Audit and Control 
Association as qualified to audit information systems and who performs 
compliance audits as a regular ongoing business activity.
    Credential means an object or data structure that authoritatively 
binds an identity (and optionally, additional attributes) to a token 
possessed and controlled by a person.
    Credential service provider (CSP) means a trusted entity that 
issues or registers tokens and issues electronic credentials to 
individuals. The CSP may be an independent third party or may issue 
credentials for its own use.
    CSOS means controlled substance ordering system.
    Digital certificate means a data record that, at a minimum--
    (1) Identifies the certification authority issuing it;
    (2) Names or otherwise identifies the certificate holder;
    (3) Contains a public key that corresponds to a private key under 
the sole control of the certificate holder;
    (4) Identifies the operational period; and
    (5) Contains a serial number and is digitally signed by the 
certification authority issuing it.

[[Page 58768]]

    Digital signature means a record created when a file is 
algorithmically transformed into a fixed length digest that is then 
encrypted using an asymmetric cryptographic private key associated with 
a digital certificate. The combination of the encryption and algorithm 
transformation ensure that the signer's identity and the integrity of 
the file can be confirmed.
    Digitally sign means to affix a digital signature to a data file.
    Electronic prescription means a prescription that is generated on 
an electronic application and transmitted as an electronic data file.
    Electronic prescription application provider means an entity that 
develops or markets electronic prescription software either as a stand-
alone application or as a module in an electronic health record 
application.
    Electronic signature means a method of signing an electronic 
message that identifies a particular person as the source of the 
message and indicates the person's approval of the information 
contained in the message.
    False match rate means the rate at which an impostor's biometric is 
falsely accepted as being that of an authorized user. It is one of the 
statistics used to measure biometric performance when operating in the 
verification or authentication task. The false match rate is similar to 
the false accept (or acceptance) rate.
    False non-match rate means the rate at which a genuine user's 
biometric is falsely rejected when the user's biometric data fail to 
match the enrolled data for the user. It is one of the statistics used 
to measure biometric performance when operating in the verification or 
authentication task. The false match rate is similar to the false 
reject (or rejection) rate, except that it does not include the rate at 
which a biometric system fails to acquire a biometric sample from a 
genuine user.
    FIPS means Federal Information Processing Standards. These Federal 
standards, as incorporated by reference in Sec.  1311.08 of this 
chapter, prescribe specific performance requirements, practices, 
formats, communications protocols, etc., for hardware, software, data, 
etc.
    FIPS 140-2, as incorporated by reference in Sec.  1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Security Requirements for Cryptographic 
Modules,'' a Federal standard for security requirements for 
cryptographic modules.
    FIPS 180-2, as incorporated by reference in Sec.  1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Secure Hash Standard,'' a Federal secure hash 
standard.
    FIPS 180-3, as incorporated by reference in Sec.  1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Secure Hash Standard (SHS),'' a Federal secure 
hash standard.
    FIPS 186-2, as incorporated by reference in Sec.  1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Digital Signature Standard,'' a Federal standard 
for applications used to generate and rely upon digital signatures.
    FIPS 186-3, as incorporated by reference in Sec.  1311.08 of this 
chapter, means the National Institute of Standards and Technology 
publication entitled ``Digital Signature Standard (DSS),'' a Federal 
standard for applications used to generate and rely upon digital 
signatures.
    Hard token means a cryptographic key stored on a special hardware 
device (e.g., a PDA, cell phone, smart card, USB drive, one-time 
password device) rather than on a general purpose computer.
    Identity proofing means the process by which a credential service 
provider or certification authority validates sufficient information to 
uniquely identify a person.
    Installed electronic prescription application means software that 
is used to create electronic prescriptions and that is installed on a 
practitioner's computers and servers, where access and records are 
controlled by the practitioner.
    Installed pharmacy application means software that is used to 
process prescription information and that is installed on a pharmacy's 
computers or servers and is controlled by the pharmacy.
    Intermediary means any technology system that receives and 
transmits an electronic prescription between the practitioner and 
pharmacy.
    Key pair means two mathematically related keys having the 
properties that:
    (1) One key can be used to encrypt a message that can only be 
decrypted using the other key; and
    (2) Even knowing one key, it is computationally infeasible to 
discover the other key.
    NIST means the National Institute of Standards and Technology.
    NIST SP 800-63-1, as incorporated by reference in Sec.  1311.08 of 
this chapter, means the National Institute of Standards and Technology 
publication entitled ``Electronic Authentication Guideline,'' a Federal 
standard for electronic authentication.
    NIST SP 800-76-1, as incorporated by reference in Sec.  1311.08 of 
this chapter, means the National Institute of Standards and Technology 
publication entitled ``Biometric Data Specification for Personal 
Identity Verification,'' a Federal standard for biometric data 
specifications for personal identity verification.
    Operating point means a point chosen on a receiver operating 
characteristic (ROC) curve for a specific algorithm at which the 
biometric system is set to function. It is defined by its corresponding 
coordinates--a false match rate and a false non-match rate. An ROC 
curve shows graphically the trade-off between the principal two types 
of errors (false match rate and false non-match rate) of a biometric 
system by plotting the performance of a specific algorithm on a 
specific set of data.
    Paper prescription means a prescription created on paper or 
computer generated to be printed or transmitted via facsimile that 
meets the requirements of part 1306 of this chapter including a manual 
signature.
    Password means a secret, typically a character string (letters, 
numbers, and other symbols), that a person memorizes and uses to 
authenticate his identity.
    PDA means a Personal Digital Assistant, a handheld computer used to 
manage contacts, appointments, and tasks.
    Pharmacy application provider means an entity that develops or 
markets software that manages the receipt and processing of electronic 
prescriptions.
    Private key means the key of a key pair that is used to create a 
digital signature.
    Public key means the key of a key pair that is used to verify a 
digital signature. The public key is made available to anyone who will 
receive digitally signed messages from the holder of the key pair.
    Public Key Infrastructure (PKI) means a structure under which a 
certification authority verifies the identity of applicants; issues, 
renews, and revokes digital certificates; maintains a registry of 
public keys; and maintains an up-to-date certificate revocation list.
    Readily retrievable means that certain records are kept by 
automatic data processing applications or other electronic or 
mechanized recordkeeping systems in such a manner that they can be 
separated out from all other records in a reasonable time and/or 
records are kept on which certain items are asterisked, redlined, or in 
some other

[[Page 58769]]

manner visually identifiable apart from other items appearing on the 
records.
    SAS 70 Audit means a third-party audit of a technology provider 
that meets the American Institute of Certified Public Accountants 
(AICPA) Statement of Auditing Standards (SAS) 70 criteria.
    Signing function means any keystroke or other action used to 
indicate that the practitioner has authorized for transmission and 
dispensing a controlled substance prescription. The signing function 
may occur simultaneously with or after the completion of the two-factor 
authentication protocol that meets the requirements of part 1311 of 
this chapter. The signing function may have different names (e.g., 
approve, sign, transmit), but it serves as the practitioner's final 
authorization that he intends to issue the prescription for a 
legitimate medical reason in the normal course of his professional 
practice.
    SysTrust means a professional service performed by a qualified 
certified public accountant to evaluate one or more aspects of 
electronic systems.
    Third-party audit means an independent review and examination of 
records and activities to assess the adequacy of system controls, to 
ensure compliance with established policies and operational procedures, 
and to recommend necessary changes in controls, policies, or 
procedures.
    Token means something a person possesses and controls (typically a 
key or password) used to authenticate the person's identity.
    Trusted agent means an entity authorized to act as a representative 
of a certification authority or credential service provider in 
confirming practitioner identification during the enrollment process.
    Valid prescription means a prescription that is issued for a 
legitimate medical purpose by an individual practitioner licensed by 
law to administer and prescribe the drugs concerned and acting in the 
usual course of the practitioner's professional practice.
    WebTrust means a professional service performed by a qualified 
certified public accountant to evaluate one or more aspects of Web 
sites.

[75 FR 16304, Mar. 31, 2010]

[FR Doc. 2012-23529 Filed 9-21-12; 8:45 am]
BILLING CODE 1505-01-D