Which of the following missing information cannot be filled by a distributor on a DEA
Form 222?
a. Date of the form
b. Size of the package
c. Strength of the drug
d. Last Line Completed - Answers-Answer: (d) Last Line Completed cannot be filled by
a distributor in sections omitted by a registrant on a DEA Form 222,
[http://www.deadiversion.usdoj.gov/faq/dea222.htm].
Date of the form: The distributor may place the date on the form. When possible, the
date ascertained from the delivery document should be used as the issue date. The
form is acceptable unless the ascertained date of issue is greater than 60 days from the
date of receipt.
Size of the package: The size of the package must be completed by the purchaser
unless the product is only manufactured in one size. If more than one package size is
manufactured and no package size is indicated, then the package size may not be
added by the supplier. The line item with the missing package size must be voided by
the supplier and the purchaser notified.
Strength of the drug: If the product is only manufactured in one strength, then it is not
necessary to indicate the strength in the section "Name of Drug". If the product is
available in more than one strength, then the strength may not be added by the
distributor. The line should be voided on the DEA Form 222 by the supplier and the
purchaser notified.
Last Line Completed: A distributor may not fill in the "Last Line Completed" area of the
DEA Form 222. This section must be completed by the purchaser. If the purchaser
enters an incorrect number, such as the total number of packages ordered instead of
the last line completed, then the DEA Form 222 is not valid.
.The CSOS digital certificate holder must report the loss, theft, or compromise of the
private key or the password, via a revocation request, to the DEA Certification Authority
within 7 days of substantiation of the loss, theft, or compromise.
a. True
b. False - Answers-Answer: (b) False, [21CFR 1311.30].
The following persons are eligible to obtain a CSOS digital certificate from the DEA
Certification Authority to sign electronic orders for controlled substances.
,(a). The person who signed the most recent DEA registration application or renewal
application and a person authorized to sign a registration application.
(b). A person granted power of attorney by a DEA registrant to sign orders for one or
more schedules of controlled substances.
A CSOS digital certificate issued by the DEA Certification Authority will authorize the
certificate holder to sign orders for only those schedules of controlled substances
covered by the registration under which the certificate is issued.
Requirements for storing and using a private key for digitally signing orders:
(a). Only the certificate holder may access or use his or her digital certificate and private
key.
(b). The certificate holder must provide FIPS-approved secure storage for the private
key, as discussed by FIPS 140-2, 180-2, 186-2.
(c). A certificate holder must ensure that no one else uses the private key. While the
private key is activated, the certificate holder must prevent unauthorized use of that
private key.
(d). A certificate holder must not make back-up copies of the private key.
(e). The certificate holder must report the loss, theft, or compromise of the private key or
the password, via a revocation request, to the Certification Authority within 24 hours
(NOT 7 days) of substantiation of the loss, theft, or compromise.
Upon receipt and verification of a signed revocation request, the Certification Authority
will revoke the certificate. The certificate holder must apply for a new certificate under
the requirements of Sec. 1311.25.
.The statement, "Caution: Federal law prohibits the transfer of this drug to any person
other than the patient for whom it was prescribed", is required when dispensing:
I. Schedule II controlled drugs.
II. Schedule III controlled drugs.
III. Schedule V controlled drugs.
a. I only
b. I and II only
c. II and III only
d. All - Answers-Answer: (b) Caution: Federal law prohibits the transfer of this drug to
any person other than the patient for whom it was prescribed is required when
dispensing Schedule II, III and IV controlled drugs.
,.What information is/are required on a prescription for a controlled substance?
I. Practitioner's name, address, and DEA registration number
II. Manual signature of the prescriber
III. Dosage form of the prescribed drug
a. I only
b. I and II only
c. II and III only
d. All - Answers-Answer: (d) All, [http://www.deadiversion.usdoj.gov/faq/general.htm].
A prescription for a controlled substance must include the following information:
1. Date of issue;
2. Patient's name and address;
3. Practitioner's name, address, and DEA registration number;
4. Drug name;
5. Drug strength;
6. Dosage form;
7. Quantity prescribed;
8. Directions for use;
9. Number of refills (if any) authorized; and
10. Manual signature of prescriber.
A prescription must be written in ink or indelible pencil or typewritten and must be
manually signed by the practitioner.
An individual may be designated by the practitioner to prepare the prescriptions for
his/her signature. The practitioner is responsible for making sure that the prescription
conforms in all essential respects to the law and regulation.
Prescriptions for schedule II controlled substances must be written and be signed by the
practitioner. In emergency situations, a prescription for a schedule II controlled
substance may be telephoned to the pharmacy and the prescriber must follow up with a
written prescription being sent to the pharmacy within seven days.
.All of the following are required on an OTC medication label EXCEPT:
, a. Inactive ingredients.
b. Directions.
c. Expiration date.
d. NDC number. - Answers-Answer: (d) The following information is required on any
OTC medication label, [21CFR201.2, 21CFR207.35, 21CFR201.6-201.63 and
21CFR201.1-201.55]:
1. Drug Facts - title
2. Active ingredient(s)-including amount in each dosage unit
3. Purpose - pharmacologic class
4. Use(s) - indications
5. Warnings
6. Do not use - absolute contraindications, when the product should not be used under
any circumstances
7. Ask a doctor before use if you have - warnings for persons with certain preexisting
conditions and for persons experiencing certain symptoms
8. Ask a doctor or pharmacist before use if you are - drug/drug and drug/food
interactions
9. When using this product - side effects that could occur and substances or activities to
avoid
10. Stop use and ask a doctor if - signs of toxicity and other serious reactions that would
require consumers to stop using the product immediately
11. Pregnancy/breast-feeding warning
12. Keep out of reach of children/Accidental overdose warnings
13. Direction - dosage and when, how, or how often to take
14. Other information
15. Inactive ingredients
16. Questions? (Optional) - followed by telephone number
17. Lot number