FD&C Act
The administration created by this act.
These must register with the DEA every year.
What is a manufacturer?
(pharmacies every 3 years using 224 form)
This schedule of drugs are not accepted for medical use.
What is CI?
(Heroin, Marijuana, LSD, Methaqualone, GHB, Methcathinone, MDMA)
(high abuse, lack safety in terms of dependence)
These prescribers must have a collaborative agreement with a physician to prescribe.
(Phys. Assistants - CII 72 hr dose initial, 30 days supply ongoing; CRNP - 30 days supply CII, 90 days CIII-IV; Nurse Midwife - CII 72 hr, 30 days CIII-CIV)
This is a class 1 medical device.
(or scissors, stethoscopes, toothbrushes)
The Durham-Humphrey amendment did this.
What is defined legend drugs?
Pharmacies may produce another dosage of a controlled sub. without being a manufacturer as long as it contains less than this percent of the drug.
What is 20%
A substance with more than 18 mg/mL of Codeine mixed with another active ingredient
What is CII?
(Hydrocodone, Morphine, Codeine, Cocaine, Oxycodone, Opium, Fentanyl, Methylphenidate, Meth)
(high abuse, severe dependence)
An optometrist may prescribe this supply of CII-CV.
What is a 6 week supply?
(NO CII)
This is the maximum number of years for a brand-name drug to be exclusive on the market.
What is 14 years?
The Kefauver-Harris amendment did this.
(also informed consent, CGMP)
Suboxone and Subutex are approved for opioid addiction but must be prescribed for this if the prescriber has no DATA 2000 waiver.
What is analgesic purposes.
(X on DEA number)
(methadone only allowed by methadone clinic if for detox, analgesic allowed)
This schedule of drugs does not require an Rx federally and contains Codeine preparations with less than 2mg/mL.
What is CV?
(Lomotil, Opium Preparations)
(low abuse, limited dependence)
OBRA-90 files/profiles must be kept for this many years.
What are 2 years?
(from date of last entry)
This is the temperature for controlled room temp. under USP guidelines.
What is 15-30C?
(cold - less than 8, cool - 8-15, refrigerator 2-8)
The Drug Quality and Security Act did this.
What is defined compounding rules as well as CGMP exceptions?
(503A - trad. pharms 503B - outsourcing)
(797 - sterile 795 - non-sterile)
This DEA form must be filled out if theft or "significant loss" occurs.
What is form 106?
(breakage/spillage and once-a-year disposal on property - form 41)
This schedule contains drugs like Phentermine, Ultram, and Zolpidem.
What is CIV?
(Alprazolam, Cholral Hydrate, Diasepam, Lorazepam, Temazepam, Carisoprodol)
(low abuse, limited dependence)
OBRA 90 mandates a DUR which includes these components.
What is a patient profile and history review, a prospective DUR, and patient counseling?
(with every new patient or prescription)
Methadone may be distributed in institutional settings for addiction treatment if for this many days.
What is 3 days?
(one day supply for max of 3 days)
The last two digits of the NDC number mean this.
What is ID of package (size)?
(first 4 - manufacturer, second 4 - ID of drug)
This many refills are allowed for a CIII-V if within 6 months of issue.
What is 5 refills?
(no refills for CII)
Drugs like Xyrem, Anabolic Steroids, Tylenol W/ Codeine, Butalbital, and Chlorphentermine have this physical and psychological dependence.
What is low/moderate physical and high psychological dependence?
True or False: (sry this is jeopardy but oh well)
Adverse effects and how to avoid them must be included in a patient counseling session.
True. :)
These are not allowed to be changed by a pharmacist on an Rx.
What is the patient name, substance name, and signature of the prescriber?