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As previously stated, a prescription
not issued in the usual course of professional practice or not for legitimate
medical/research purposes is not considered valid. Both the practitioner and
the pharmacy have a responsibility to ensure that only legitimate
prescriptions are written and filled. General Information
What are the basic
requirements for prescribing, dispensing, and importing controlled
substances? Only practitioners acting in the
usual course of their professional practice may prescribe controlled
substances. These practitioners must be registered with DEA and licensed to
prescribe controlled substances by the State(s) in which they operate. Pharmacies
filling prescriptions for controlled substances must also be registered with
DEA and licensed to dispense controlled substances by the State(s) in which
they operate. A prescription not issued in the usual course of professional
practice or not for legitimate and authorized research is not considered
valid. Both the practitioner and the pharmacy have a responsibility to ensure
that only legitimate prescriptions are written and filled. Pharmacists must receive written and
manually signed prescriptions for Schedule II substances. They may receive
oral or faxed prescriptions for Schedule III-V substances provided they confirm the legitimacy of the prescription and the practitioner. Prescriptions for Schedule II controlled substances may not be refilled. Prescriptions for Schedule III-V controlled substances may be authorized to be refilled |
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five times, but no prescription may
be filled or refilled more than six months after the date on which the
prescription was issued. Only those people who are registered with DEA as
importers and who are in compliance with DEA requirements may have controlled
substances shipped into the customs territory or jurisdiction of the U.S.
from a foreign country. DEA regulations covering
prescriptions can be found in Title 21 of the Code of Federal Regulations,
part 1306; rules on importers are found in 21 CFR 1312. Questions for DEA
Registrants Is it legal for
Internet pharmacies to approach a physician to write prescriptions based on? on-line
consultations with customers/consumer? A physician may use the Internet to
provide information and to communicate with the patient, but it cannot be the
sole basis for authorizing prescriptions. If a doctor/patient relationship
exists, a doctor can use the Internet to communicate with patients. Where a
doctor/patient relationship exists, the doctor may use the Internet to
receive requests for treatment. DEA cautions, however, that such requests for
treatment should be logical based upon a doctor's knowledge of the patient's
medical history and the medical complaint. The doctor may also use the
Internet to receive requests for refills of prescriptions from patients. Can an independent
pharmacy purchase supplies on the Internet? What procedures must be followed?
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Pharmacies can use the Internet to
facilitate their purchases; however, the basic regulations' regarding
registration and recordkeeping apply. The pharmacy can only purchase from a
registered supplier and the pharmacy must maintain complete and accurate records
describing the name, address and registration number of the supplier, a
description of the drugs purchased, and the date the drugs are received. For
Schedule II controlled substances, official DEA Order Forms must be used.
Recordkeeping requirements for dispensers can be found in Section 1304 of the
Code of Federal Regulations (see 21 CFR 1304.22(c». Recordkeeping
requirements pertaining to the use of official Order Forms can be found in
Section 1305 of the Code of Federal Regulations. Does the label on a prescription
filled via the Internet indicate the Internet pharmacy or the registered
location that filled the prescription? The label must list the name and
registered location of the pharmacy that dispensed the controlled substance. Does being an
Internet pharmacy change a pharmacy's responsibilities under DEA regulations?
No, Internet pharmacies are still
authorized to sell controlled substances only when there is a valid
prescription from a DEA-registered practitioner who issued the prescription
in the usual course of his or her professional practice. Is it possible for
an Internet pharmacy to fill prescriptions for Schedule II controlled
substances? An Internet pharmacy may fill valid prescriptions for Schedule II substances if the patient or prescribers provides the |
