Controlled Substances
In what schedule did DEA list carisoprodol products? - answerIV
What changes can be made to Schedule II Prescriptions? - answerdate of issue - may
be added but not changed;
patient's address;
drug strength;
drug dosage form;
drug quantity - may be modified in conjunction with change in strength only, not to
exceed the original total dosage prescribed; and
directions for use.
What changes may not be made to Schedule II Prescriptions? - answername of the
drug (except to generic when appropriate)
name of the patient
signature of the practitioner.
Can a pharmacist change or add the correct amount of acetaminophen to a prescription
for a combination product containing a schedule II drug and acetaminophen? -
answerYes
after speaking directly with the prescriber and documenting the clarification on the
prescription
Are there any exemptions to Controlled Substance Reporting System requirements
regarding distribution of controlled substance samples? - answerYes
"A dispenser shall not be required to report instances in which a Schedule V non-
narcotic, non-anorectic Schedule V controlled substance is provided directly to the
ultimate user for
the purpose of assessing a therapeutic response
when prescribed according to indications approved by the United States Food and Drug
Administration."
How must controlled substances maintained in a practitioner's office (as opposed to a
pharmacy) for dispensing or administration be stored? - answerLocked cabinet or other
secure storage container with limited access by the office staff. FCSA
,What is the NC Medical Board's position on the use of opiates to treat pain? -
answerBasically there are no regulations but prescribers need to be careful.
http://www.ncmedboard.org/resources-information/professional-resources/laws-rules-
position-statements/position-statements/
Policy_for_the_use_of_opiates_for_the_treatment_of_pain.
Is it "legal" for a pharmacist to add a DEA number to a controlled substance prescription
when the prescriber omits that information? - answeryes
Are pharmacists required to hand sign and date controlled substance prescriptions? -
answerno
May a prescribing practitioner prescribe other medications on a prescription that already
includes a Schedule II medication? - answeryes
Can I fill Schedule II prescriptions bearing a "do not fill until" date? - answeryes
What are the rules around issuance of multiple prescriptions for CIIs? - answer(a) No
CII refills
(b) Prescriber may issue multiple Rx's to provide (no more than a) 90 day supply
Common Sense Stuff:
(i) Each separate prescription is issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of professional practice;
(ii) The individual practitioner provides written instructions on each prescription (other
than the first prescription, if the prescribing practitioner intends for that prescription to be
filled immediately) indicating the earliest date on which a pharmacy may fill each
prescription;
(iii) The individual practitioner concludes that providing the patient with multiple
prescriptions in this manner does not create an undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section is permissible
under the applicable state laws; and
(v) The individual practitioner complies fully with all other applicable requirements under
the Act and these regulations as well as any additional requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging
individual practitioners to issue multiple prescriptions or to see their patients only once
every 90 days when prescribing Schedule II controlled substances. Rather, individual
practitioners must determine on their own, based on sound medical judgment, and in
accordance with established medical standards, whether it is appropriate to issue
multiple prescriptions and how often to see their patients when doing so.
What information must be reported under the controlled substance reporting act? -
answer(1) Dispenser's AND Prescriber DEA number.
(2) Pt Name
Full address
Telephone number
, Date of birth.
(3) Date writen
(4) Date filled.
(5) Rx number.
(6) Whether the prescription is new or a refill.
(7) Dispense quantity
(8) Days supply
(9) National Drug Code of dispensed drug.
Who is a dispenser under the controlled substance act?
Who is NOT a dispenser - answer"a person who delivers a Schedule II through V
controlled substance to an ultimate user in North" ACCEPT:
a. Hospital or long term care pharmacy that dispenses for inpatient administration.
b. A person authorized to administer such a substance pursuant to Chapter 90 of the
General Statutes.
c. A wholesale distributor of a Schedule II through V controlled substance.
What is my responsibility as a pharmacist in case of drug loss or theft? - answer1. Notify
DEA within ONE BUSINESS DAY of discovery of such loss or theft.
2. complete a DEA 106 regarding the loss or theft.
3. If loss is "SIGNIFICANT" A Drug Disaster & Loss Report should also be completed
and filed with the NC Board of Pharmacy office within 10 days of the drug loss/theft.
May a technician, certified technician, or pharmacy student transfer or receive transfers
of prescriptions for controlled substances? - answerNo, only pharmacists
Can prescription blanks for controlled substances be pre-printed? - answerNo preprints
No stamped or electronic prescriber signatures
Note: A computer-generated controlled substance prescription is not considered "pre-
printed" so long as the prescription was generated for an individual patient, and not
"mass printed."
Are pharmacists required to "cancel" a prescription for a controlled substance by
drawing a line from one corner to the other of the prescription document? - answerNo,
this is not a federal or state requirement
What collection methods of pharmaceutical controlled substances does the DEA
authorize? - answera. Collection receptacles
b. Mail-back programs
c. Take back events conducted by law enforcement only
In what schedule did DEA list carisoprodol products? - answerIV
What changes can be made to Schedule II Prescriptions? - answerdate of issue - may
be added but not changed;
patient's address;
drug strength;
drug dosage form;
drug quantity - may be modified in conjunction with change in strength only, not to
exceed the original total dosage prescribed; and
directions for use.
What changes may not be made to Schedule II Prescriptions? - answername of the
drug (except to generic when appropriate)
name of the patient
signature of the practitioner.
Can a pharmacist change or add the correct amount of acetaminophen to a prescription
for a combination product containing a schedule II drug and acetaminophen? -
answerYes
after speaking directly with the prescriber and documenting the clarification on the
prescription
Are there any exemptions to Controlled Substance Reporting System requirements
regarding distribution of controlled substance samples? - answerYes
"A dispenser shall not be required to report instances in which a Schedule V non-
narcotic, non-anorectic Schedule V controlled substance is provided directly to the
ultimate user for
the purpose of assessing a therapeutic response
when prescribed according to indications approved by the United States Food and Drug
Administration."
How must controlled substances maintained in a practitioner's office (as opposed to a
pharmacy) for dispensing or administration be stored? - answerLocked cabinet or other
secure storage container with limited access by the office staff. FCSA
,What is the NC Medical Board's position on the use of opiates to treat pain? -
answerBasically there are no regulations but prescribers need to be careful.
http://www.ncmedboard.org/resources-information/professional-resources/laws-rules-
position-statements/position-statements/
Policy_for_the_use_of_opiates_for_the_treatment_of_pain.
Is it "legal" for a pharmacist to add a DEA number to a controlled substance prescription
when the prescriber omits that information? - answeryes
Are pharmacists required to hand sign and date controlled substance prescriptions? -
answerno
May a prescribing practitioner prescribe other medications on a prescription that already
includes a Schedule II medication? - answeryes
Can I fill Schedule II prescriptions bearing a "do not fill until" date? - answeryes
What are the rules around issuance of multiple prescriptions for CIIs? - answer(a) No
CII refills
(b) Prescriber may issue multiple Rx's to provide (no more than a) 90 day supply
Common Sense Stuff:
(i) Each separate prescription is issued for a legitimate medical purpose by an individual
practitioner acting in the usual course of professional practice;
(ii) The individual practitioner provides written instructions on each prescription (other
than the first prescription, if the prescribing practitioner intends for that prescription to be
filled immediately) indicating the earliest date on which a pharmacy may fill each
prescription;
(iii) The individual practitioner concludes that providing the patient with multiple
prescriptions in this manner does not create an undue risk of diversion or abuse;
(iv) The issuance of multiple prescriptions as described in this section is permissible
under the applicable state laws; and
(v) The individual practitioner complies fully with all other applicable requirements under
the Act and these regulations as well as any additional requirements under state law.
(2) Nothing in this paragraph (b) shall be construed as mandating or encouraging
individual practitioners to issue multiple prescriptions or to see their patients only once
every 90 days when prescribing Schedule II controlled substances. Rather, individual
practitioners must determine on their own, based on sound medical judgment, and in
accordance with established medical standards, whether it is appropriate to issue
multiple prescriptions and how often to see their patients when doing so.
What information must be reported under the controlled substance reporting act? -
answer(1) Dispenser's AND Prescriber DEA number.
(2) Pt Name
Full address
Telephone number
, Date of birth.
(3) Date writen
(4) Date filled.
(5) Rx number.
(6) Whether the prescription is new or a refill.
(7) Dispense quantity
(8) Days supply
(9) National Drug Code of dispensed drug.
Who is a dispenser under the controlled substance act?
Who is NOT a dispenser - answer"a person who delivers a Schedule II through V
controlled substance to an ultimate user in North" ACCEPT:
a. Hospital or long term care pharmacy that dispenses for inpatient administration.
b. A person authorized to administer such a substance pursuant to Chapter 90 of the
General Statutes.
c. A wholesale distributor of a Schedule II through V controlled substance.
What is my responsibility as a pharmacist in case of drug loss or theft? - answer1. Notify
DEA within ONE BUSINESS DAY of discovery of such loss or theft.
2. complete a DEA 106 regarding the loss or theft.
3. If loss is "SIGNIFICANT" A Drug Disaster & Loss Report should also be completed
and filed with the NC Board of Pharmacy office within 10 days of the drug loss/theft.
May a technician, certified technician, or pharmacy student transfer or receive transfers
of prescriptions for controlled substances? - answerNo, only pharmacists
Can prescription blanks for controlled substances be pre-printed? - answerNo preprints
No stamped or electronic prescriber signatures
Note: A computer-generated controlled substance prescription is not considered "pre-
printed" so long as the prescription was generated for an individual patient, and not
"mass printed."
Are pharmacists required to "cancel" a prescription for a controlled substance by
drawing a line from one corner to the other of the prescription document? - answerNo,
this is not a federal or state requirement
What collection methods of pharmaceutical controlled substances does the DEA
authorize? - answera. Collection receptacles
b. Mail-back programs
c. Take back events conducted by law enforcement only
