The Attorney General
Who determines the schedule classification for new controlled substances?
anabolic steroid
Any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, and corticosteroids) that promotes muscle growth
records that are kept in such a manner that they can be separated out from all other records in a reasonable time
Readily retreivable
reverse distributor
a registrant who receives controlled substances acquired from another DEA registrant for the purpose of returning unwanted, unusable, or outdated controlled substances to the manufacturer or the manufacturer's agent or processing such substances for dispo
scheduled listed chemical product
a product that contains ephedrine, pseudoephedrine, or phenylpropanolamine
No, hospital registrations are issued to the entire hospital as an institutional practitioner
Do pharmacists who work in a registered establishment such as a hospital need to register with the DEA?
Form 224
What DEA registration form must be used by pharmacies applying for registration?
36 months
How long is a DEA registration valid?
60 days before the expiration date of the registration
- registrants must notify the DEA in writing if they have not received their renewal forms within 45 days of their expiration date
When should registrants receive registration renewal forms?
No
Does the applicant for DEA registration have to be a pharmacist?
- warehouses used by registrants to store controlled substances
- a practitioner's office where drugs are prescribed but not administered or dispensed
- common carriers (freight delivery companies)
- an office where sales of controlled substances are soli
Every location where controlled substances are manufactured, distributed, or dispensed must have its own DEA registration EXCEPT for:
- high potential for abuse
- no currently accepted medical use in treatment in the US
- lack accepted information on the safety of their use, even under medical supervision
examples: heroin, LSD, marijuana
Characteristics of drugs classified as Schedule I Controlled Substances
- high potential for abuse
- have currently accepted medical use in treatment in the US
- abuse of the drug may lead to severe physical or psychological dependence
examples: cocaine, codeine, hydrocodone, hydromorphone, merperidine, methadone, morphine, o
Characteristics of drugs classified as Schedule II Controlled Substances
- have potential for abuse, less than that of drugs in schedule I or II
- have a currently accepted medical use in treatment in the US
- abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence
Characteristics of drugs classified as Schedule III Controlled Substances
- have a low potential for abuse relative to schedule III drugs
- have a currently accepted medical use in treatment in the US
- abuse may lead to limited physical or psychological dependence relative to the drugs in schedule III
examples: benzodiazepines
Characteristics of drugs classified as Schedule IV Controlled Substances
- have a low potential for abuse relative to schedule IV drugs
- have a currently accepted medical use in treatment in the US
- abuse may lead to limited physical or psychological dependence relative to the drugs in schedule IV
examples: Lyrica, Lomotil.
Characteristics of drugs classified as Schedule V Controlled Substances
DEA Form 222
Which DEA form is required for each sale or transfer of a schedule I or II controlled substance?
the same person who signed the most recent application for registration or re-registration and by the individual being given authorization to obtain and execute order forms
Who must sign the Power of Attorney to obtain and execute DEA order forms?
- Copy 1 (brown) goes to the supplier
- Copy 2 (green) goes to the supplier first and then the supplier forwards it to the DEA
- Copy 3 (blue) is kept by the purchaser and then the purchaser must record on copy 3 of the order form the number of containers
How are the triplicate 222 forms used to order controlled substances?
Yes - the balance must be supplied within 60 days following the date of the order form
The order form is no longer valid after 60 days from the time it was executed by the purchaser
If a controlled substance order cannot be completely filled, can it be partially filled?
immediately report it to the DEA
- include serial number of each form lost or stolen
What should you do if an order form has been lost or stolen?
CSOS (Controlled Substance Ordering System)
Electronic ordering of controlled substances can be done via _______.
The individual purchaser must acquire a CSOS digital certificate using PKI technology
(public key infrastructure)
How do you enroll in CSOS?
No, that is not permissible. The practitioner must order controlled substances directly from a supplier (wholesaler or manufacturer)
Can a practitioner prescribe controlled substances for "office use"?
- date written
- signature
- full name of patient
- patient address
- drug name, strength, dosage form
- quantity
- directions for use
- name, address, registration number of practitioner
All controlled substance prescriptions must include:
Not for C-II
Yes for C-III, C-IV, C-V
Are oral prescriptions valid for controlled substances?
The physician CANNOT PRESCRIBE narcotics for this situation.
The physician CAN ADMINISTER one day's medication to the person. Such emergency treatment may be carried out for NOT MORE THAN 3 DAYS and may not be renewed or extended.
Can a physician who is not specifically registered to conduct a narcotic treatment program administer or prescribe narcotics for the purpose of relieving acute withdrawal symptoms while arrangements are being made for referral for treatment?
Yes, but:
- the quantity dispensed must be limited to the amount adequate to treat the patient during the emergency period
- the prescription must be immediately written by the pharmacist and contain all necessary information except for the prescriber's s
In an emergency situation, can a pharmacist dispense a C-II oral prescription?
- home infusion pharmacies receiving prescriptions intended for parenteral administration
- a resident of a long term care facility
- hospice patients
When is faxing a C-II prescription allowed?
Yes and the pharmacist must:
- note the quantity dispensed on the face of the prescription
- the remaining portion must be filled WITHIN 72 HOURS of the first partial fill
- if the remaining quantity cannot be supplied within 72 hours, the pharmacist must
Are pharmacists allowed to partial fill a C-II prescription?
- date of partial fill
- quantity dispensed
- remaining quantity to be dispensed
- identification of dispensing pharmacist
For each partial filling of a C-II, what must a pharmacist record on the BACK of the prescription?
Prescriptions for Schedule III and IV prescriptions may be refilled not more than 5 times in a 6 month period from the date the prescription was issued, if authorized by the prescriber
Schedule V prescriptions can be refilled in accordance with the prescr
What does federal law permit regarding refilling of Schedule III, IV, and V prescriptions?
Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed
What warning must be applied to the prescription container of Schedule II, III, and IV prescriptions except those that are used in blinded clinical trials?
Yes, but only on a one time basis unless it is between pharmacies that share an electronic real-time online database (then it can be transferred multiple times).
Can original prescription information for a Schedule III, IV, or V controlled substance be transferred between pharmacies?
no more than 4 ounces to a person in a 48 hour period
- purchaser must be at least 18
Log book must contain:
- name & address of purchaser
- drug and quantity purchased
- date of purchase
- name or initials of pharmacist
What quantity of a codeine-containing over the counter cough medication can a pharmacist sell without a prescription?
- Contact the DEA for a list of reverse distributors
- Reverse distributor must issue a DEA 222 Form to the pharmacy
- Reverse distributor submits a DEA Form 41 after drugs have been destroyed
How should a pharmacy dispose of C-II drugs?
A pharmacist may transfer up to 5% of the total dosage units of controlled substances dispensed in a given calendar year by the pharmacy without getting a wholesaler's permit. DEA Form 222 must be used in transferring Schedule I and II controlled substanc
Can a pharmacist transfer controlled substances between pharmacies without obtaining a wholesaler's permit?
- Inventory must be maintained separately from other pharmacy records
- Prescriptions must be kept in a separate prescription file
- Biennial (at least once every 2 years) inventory must be taken
- Must have an exact count of C-II substances in sealed, un
What are the inventory requirements for C-II drugs?
The face of the prescription must be stamped in RED INK in the lower right corner with the letter "C" no less than 1 inch high and can be filed either with C-II prescriptions or non-controlled prescriptions
If a pharmacy does NOT maintain a computer record of C-III, C-IV, and C-V prescriptions, how must the pharmacy make sure these prescriptions are readily retrievable?
A, B, or F
DEA numbers for physicians, dentists, and veterinarians begin with what letter?
M
DEA numbers for mid-level practitioners begin with what letter?
either the practitioner's last name or business name
The second letter of a DEA number represents:
1. Add the 1st, 3rd, and 5th digits
2. Add the 2nd, 4th, and 6th digits. Multiply this sum by 2.
3. Add the results of step 1 and step 2. The last digit of this sum should be the same as the last digit in the DEA number
How can a DEA number be verified?
- Contact the nearest DEA Diversion Field Office immediately upon discovery
- Notify local police
- Complete DEA Form 106
What should a pharmacy do in the event of theft of controlled substances?
- Retail sales of no more than 3.6 grams per day per purchaser
- Individuals cannot purchase more than 9 grams of PSE per 30-day period
Federal limits on the retail sales of PSE products: