Federal Regulations Flashcards
Pure Food and Drug Act (1906)
- Prohibits interstate commerce of misbranded and adultered drugs and foods
Misbranded: A drug product is mislabeled if it is inaccurate, incomplete, or misleading
Federal Food, Drug, and Cosmetic Act (1938)
- Requires drug manufacturers to provide the FDA with evidence of safety by submitting a New Drug Application
- If the FDA does not take action within 60 days, the drug is automatically approved
Durham-Humphrey Amendment (1951)
- Defines two specific categories for drug products: legend (Rx) drugs and over-the-counter (OTC) medication
- Legend (Rx) drugs must be labeled with “Caution: Federal law prohibits dispensing without a prescription.”
Kefauver-Harris Amendment (1962)
- Established a framework that requires drug manufacturers to scientifically prove that a medication is not only safe but effective
- Before this amendment, drug manufacturers only had to prove that the drug was safe
Controlled Substance Act (CSA) (1970)
- Federal drug policy that regulates the manufacture, importation, possession, use, and distribution of controlled substances: certain narcotics, stimulants, depressants, hallucinogens, and anabolic steroids
- CSA classifies controlled substances into five schedules: I, II, III, IV, V
- Drugs are placed in different schedules depending on their medical and potential for abuse or dependence
Schedule I Controlled Substances
- Have a high potential for abuse and physical/psychological dependence
- Currently have no accepted medical use and are considered investigational or illicit drugs
Schedule II Controlled Substances
- Have a high potential for abuse and physical/psychological dependence. However, they are acceptable for medicinal use
- CSA has more strict regulations on prescribing, distribution, and dispensing of CII substances
Schedule III Controlled Substances
- Have a moderate to low potential for physical dependence but a high potential for psychological dependence
Schedule IV Controlled Substances
- Have a low potential for abuse and dependence but can still lead to addiction and have dangerous effects if combined with other substances of abuse
Schedule V Controlled Substances
- Have a low potential for abuse and dependence. These products may contain limited quantities of certain narcotics
T or F: C-II refills are permitted
FALSE
C-II refills are NOT permitted. A new prescription must be issued for each fill
How many refills are permitted for CIII-CIV medications?
5 refills or refills for up to six months from the date of issuance, whichever comes first
How many refills are permitted for CV medications?
Can be refilled as many times as authorized by the prescriber per federal law but states may differ
What is the expiration date of CII medications?
No expiration per federal law but states may differ
What is the expiration date of CIII-CIV medications?
Valid for six months from the date of issuance
What is the expiration date of CV medications?
No expiration per federal law but states may differ
How many partial fills are permitted for CII medications?
Partial fill is permitted as long as the remainder is filled within 72 hours
How many partial fills are permitted for CIII-CIV medications?
Partial fills are permitted with no time limit as long as the prescription has not expired
Is transferring CII medication refills permitted?
Transfer is prohibited
Is transferring CII-V medication refills permitted?
Allow one-time transfer between two pharmacies
What is DEA Form 41 used for?
Reporting destruction of CS
What is DEA Form 104 used for?
Reporting pharmacy closure or surrender of a pharmacy permit
What is DEA Form 106 used for?
Reporting loss of theft of CS
What is DEA Form 222 used for?
Ordering CI and CII CS
What is DEA Form 222a used for?
Ordering more of Form DEA 222
What is DEA Form 224 used for?
Applying for a DEA registration number
What is DEA Form 224a used for?
DEA registration renewal, must be renewed every 3 years
What letters are valid for DEA numbers?
A, B, F: Physicians, dentists, veterinarians, pharmacies, and hospitals
M: Allied health practitioners
P and R: Manufacturers, distributors, narcotic treatment programs, and researchers
How to verify a DEA number?
- Add the first, third, and fifth digit of the DEA number
- Add the second, fourth, and sixth digit of the DEA number, then multiply the sum by 2
- Add the result of step one and step two
- The sum from step 3 will be a two-digit number, the second number will match the seventh number of the DEA number
Poison Prevention Packaging Act (PPPA) (1070)
- Aims to protect young children from poisonings and deaths that can occur if they gain access to hazardous products including medications
- Requires most over-the-counter and Rx drugs to be packaged in child-resistant containers to make it significantly hard for five-years-old to open
Federal Anti-Tampering Act (1983)
- Mandates that OTC medications must have a tamper-evident seal
Prescription Drug Marketing Act (1987)
- Prohibits the selling, purchasing, and trading of prescription drug samples
Omnibus Budget Reconciliation Act (OBRA) (1990)
- Drug utilization review (DUR), patient counseling standards, and patient record maintenance
What is a Drug Utilization Review (DUR)?
- DUR requires pharmacists to review if the prescription is necessary and appropriate
- There are two types: Prospective DUR and Retrospective DUR
What is a Prospective DUR?
- Performed by a pharmacist before a drug is dispensed and considers therapeutic duplications, drug interactions, drug allergies, over/underutilization, and potential misuse
What is a Retrospective DUR?
- Performed after the patient has received the medication and is often used to detect prescribing or dispensing patterns
What are Patient Counseling Standards?
- An offer to counsel must be made to every patient
What is Patient Record Maintenance?
- Patient records or profiles should be accurately maintained by all pharmacy staff
Dietary Supplement Health and Education Act (DSHEA) (1994)
- Dietary supplements such as vitamins and herbal supplements are considered “food”
Health Insurance Portability and Accountability Act (HIPPA) (1996)
- Limits the use and disclosure of protected health information
- Provides an option for the patient to obtain a copy of their health information
Food and Drug Administration Modernization Act (FDAMA) (1997)
- This act eliminates certain labeling requirements, “Caution: Federal Law prohibits dispensing without a prescription” may be stated as “Rx only”
Drug Addiction Treatment Act (DATA) (2000)
- Allows qualified prescribers to complete training and register for a Narcotic Addiction DEA Number (NADEAN)
- NADEAN begins with X
Combat Methamphetamine Epidemic Act (CMEA) (2005)
- Regulates the sale of over-the-counter products containing pseudoephedrine and ephedrine which can be used to make methamphetamine (meth=illegal)
- Patients are required to present a valid government-issued photo ID
- Daily limit: 3.6g per customer
- No more than 9g per 30 days if purchased in-store, 7.5g per day if online
- Pharmacies must keep a written or electronic record (to be kept for 2 years) of all OTC sales containing pseudoephedrine and ephedrine
