§1311.300. Application provider requirements—Third-party audits or certifications. — Inbound Citations
21 C.F.R. § 1311.300
Statutory Authority
Cited by 4 regulations in release Current.
Citations to 21 C.F.R. § 1311.300 as a whole
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(e) An electronic prescription or pharmacy application provider must retain third party audit or certification reports as required by § 1311.300 of this chapter.
Citations to §1311.300(b)
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(e) If a certifying organization whose certification process has been approved by DEA verifies and certifies that an electronic prescription or pharmacy application meets the requirements of this part, certification by that organization may be used as an alternative to the audit requirements of paragraphs (b) through (d) of this section, provided that the certification that determines that the application meets the requirements of this part occurs at each of the following times:(1) Before the application may be used to create, sign, transmit, or process controlled substance prescriptions.(2) Whenever a functionality related to controlled substance prescription requirements is altered or every two years, whichever occurs first.
Citations to §1311.300(c)
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(e) If a certifying organization whose certification process has been approved by DEA verifies and certifies that an electronic prescription or pharmacy application meets the requirements of this part, certification by that organization may be used as an alternative to the audit requirements of paragraphs (b) through (d) of this section, provided that the certification that determines that the application meets the requirements of this part occurs at each of the following times:(1) Before the application may be used to create, sign, transmit, or process controlled substance prescriptions.(2) Whenever a functionality related to controlled substance prescription requirements is altered or every two years, whichever occurs first.
Citations to §1311.300(d)
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(e) If a certifying organization whose certification process has been approved by DEA verifies and certifies that an electronic prescription or pharmacy application meets the requirements of this part, certification by that organization may be used as an alternative to the audit requirements of paragraphs (b) through (d) of this section, provided that the certification that determines that the application meets the requirements of this part occurs at each of the following times:(1) Before the application may be used to create, sign, transmit, or process controlled substance prescriptions.(2) Whenever a functionality related to controlled substance prescription requirements is altered or every two years, whichever occurs first.