FDRL Flashcards
LIST OF CIV
List of Schedule IV controlled drugs:
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Tramadol (Ultram) Alprazolam (Xanax) Barbital (Barbitone) Butorphanol (Stadol, Stadol NS, Torbugesic, Torbutrol) Carisoprodol (Soma) Chloral hydrate (Noctec) Chlordiazepoxide (Librium, Libritabs, Limbitrol, SK-Lygen) Clonazepam (Klonopin, Clonopin) Clorazepate(Tranxene) Dexfenfluramine (Redux) Propoxyphene dosage forms with other ingredients (Darvon, Darvocet, Dolene, Propacet) Diazepam (Valium, Valrelease) Dichloralphenazone (Midrin) Difenoxin 1 mg/ Atropine 25 mcg (Motofen) Estazolam (ProSom, Domnamid, Eurodin, Nuctalon) Ethchlorvynol (Placidyl) Fenfluramine (Pondimin, Ponderal) Flurazepam (Dalmane) Lorazepam (Ativan) Mazindol (Sanorex, Mazanor) Meprobamate (Miltown, Equanil, Deprol, Equagesic, Meprospan) Midazolam (Versed) Modafinil (Provigil) Oxazepam (Serax, Serenid-D) Pemoline (Cylert) Pentazocine (Talwin, Talwin NX, Talacen, Talwin Compound) Phenobarbital (Luminal, Donnatal, Bellergal-S) Phentermine (Ionamin, Fastin, Adipex-P, Obe-Nix, Zantryl) Prazepam (Centrax) Quazepam (Doral, Dormalin) Sibutramine (Meridia) Temazepam (Restoril) Triazolam (Halcion) Zaleplon (Sonata) Zolpidem (Ambien) Eszopiclone (Lunesta)
LIST OF CII
Alfentanil (Alfenta) Amobarbital (Amytal, Tuinal) Amphetamine (Dexedrine, Biphetamine)
Coca Leaves Cocaine Codeine Dextropropoxyphene, bulk (non-dosage forms) Dihydrocodeine (Didrate, Parzone) Diphenoxylate Diprenorphine Ecgonine (Cocaine precursor, in Coca leaves) Ethylmorphine (Dionin) Fentanyl (Innovar, Sublimaze, Duragesic) Glutethimide (Doriden, Dorimide) Hydrocodone (dihydrocodeinone)
Hydrocodone and isoquinoline alkaloid
Hydrocodone combination product (Tussionex, Tussend, Lortab, Vicodin, Hycodan, Anexsia)Hydromorphone (Dilaudid, dihydromorphinone) Levo-alphacetylmethadol (LAAM, long acting methadone, levomethadyl acetate)
Lisdexamfetamine (Vyvanse)Meperidine (Demerol, Mepergan, pethidine) Methadone (Dolophine, Methadose, Amidone) Methamphetamine (Desoxyn, D-desoxyephedrine, ICE, Crank, Speed) Methylphenidate (Ritalin) Morphine (MS Contin, Roxanol, Duramorph, RMS, MSIR) Opium poppy Opium tincture Opium, granulated Opium, powdered Opium, raw Oxycodone (OxyContin, Percocet, Tylox, Roxicodone, Roxicet) Oxymorphone (Numorphan) Pentobarbital (Nembutal) Poppy Straw Concentrate Remifentanil (Ultiva) Secobarbital (Seconal, Tuinal) Sufentanil (Sufenta)
Tapentadol (Nucynta)
ALL IS REQUIRED ON MANDATORY DAILY HARD COPY PRINT OUT BY DATA PROCESSING SYSTEM EXCEPT: A. patient name. B. quantity dispensed. C. patient’s address. D. date of issuing.
(d) Date of issuing, [21CFR1306.22(f)(3)-to-(4)].
1. Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original paper, fax, or oral prescription order for a Schedule III or IV controlled substance is correct must be provided by the individual pharmacist who makes use of such an application.
2. If such an application provides a hard-copy printout of each day’s controlled substance prescription order refill data, that printout shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order.
3. The individual pharmacist must verify that the data indicated are correct and then sign this document in the same manner as he would sign a check or legal document (e.g., J.H. Smith, or John H. Smith).
4. This document shall be maintained in a separate file at that pharmacy for a period of two years from the dispensing date.
5. This printout of the day’s controlled substance prescription order refill data must be provided to each pharmacy using such a computerized application within 72 hours of the date on which the refill was dispensed. It must be verified and signed by each pharmacist who is involved with such dispensing.
6. In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown. Such a book or file must be maintained at the pharmacy employing such an application for a period of two years after the date of dispensing the appropriately authorized refill.
7. Any such computerized application shall have the capability of producing a printout of any refill data that the user pharmacy is responsible for maintaining under the Act and its implementing regulations. For example, this would include a refill-by-refill audit trail for any specified strength and dosage form of any controlled substance (by either brand or generic name or both).
8. Such a printout must include:
a. name of the prescribing practitioner,
b. name and address of the patient,
c. quantity dispensed on each refill,
d. date of dispensing (not issuing) for each refill,
e. name or identification code of the dispensing pharmacist, and
f. the number of the original prescription order.
In any computerized application employed by a user pharmacy the central recordkeeping location must be capable of sending the printout to the pharmacy within 48 hours, and if a DEA Special Agent or Diversion Investigator requests a copy of such printout from the user pharmacy, it must, if requested to do so by the Agent or Investigator, verify the printout transmittal capability of its application by documentation (e.g., postmark).
WHAT IS LTCF?
The term Long Term Care Facility (LTCF) means a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients, [21CFR1300.01 Definitions-25].
WHAT IS SKILLED NURSING HOME?
A Skilled Nursing Facility is a nursing home that meets criteria for accreditation established by the sections of the Social Security Act that determine the basis for Medicaid and Medicare reimbursement for skilled nursing care.
Skilled nursing care includes rehabilitation and various medical and nursing procedures.
WHAT IS ICF?
An Intermediate Care Facility (ICF) is a nursing home that is recognized only under Medicaid.
WHAT ARE MID LEVEL PRACTIONERS
ANYONE OTHER THAN 1. PHYSICIAN 2. DENTIST 3. VETERINARIAN 4. PODIATRIST who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice.
DEA 222 IS USED FOR?
ORDERING CONTROL SUBSTANCES
DEA 224 IS USED FOR?
NEW REGISTRATION FOR DISPENSING
DEA 225 IS USED FOR?
NEW NEW REGISTRATION FOR EVERYTHING ELSE BUT DISPENSING MANUFACTURING, DISTRIBUTION, REVERSE DISTRIBUTION, IMPORTING, CHEMICAL ANALYSIS OR RESEARCH
DEA 363 IS USED FOR?
NEW REGISTRATION FOR NARCOTIC TREATMENT PROGRAM
DEA 224A
RENEWAL FOR DISPENSING
DEA 225A
RENEWAL OF EVERYTHING ELSE BUT DISPENSING
DEA 363A IS USED FOR?
RENEWAL OF NARCOTIC TREATMENT PROGRAM
DEA 41 IS USED FOR?
DESTRUCTION OF CONTROL SUBSTANCES.
WHAT IS THE SCHEDULE OF DIFENOXIN?
CI
WHAT IS THE SCHEDULE OF MESCALINE
CI
WHAT IS THE SCHEDULE OF PEYOTE
CI
HOW MUCH CODEINE SHOULD BE PRESENT IN A MIXTURE TO BE CLASSIFIED AS CIII
LESS THAN 1.8 GRAMS PER 100ML
WHAT IS THE CLASSFICATION OF LOMOTIL?
CV
WHAT IS THE CLASSIFICATION OF EZOGABINE
CV
WHAT SHOULD BE THE CONC OF CODEINE IN A MIXTURE TO BE CLASSIFIED AS CV?
NOT MORE THAN 200MG PER 100ML OR GM (ROBITTUSIN AC OR PHENERGAN WITH CODEINE)
WHAT SHOULD BE THE CONC OF DIFENOXIN IN A MIXTURE TO BE CLASSIFIED AS CV?
NOT MORE THAN 0.5MG DIFENOXIN + 25MCG OF ATROPINE SULFATE (MOTOFEN)
WHAT SHOULD BE THE CONC OF DIHYDROCODEINE IN A MIXTURE TO BE CLASSIFIED AS CV?
NOT MORE THAN 100MG PER 100ML OR GRAM
