PTCB PREP: SECTION 2 - Federal Drug Regulations

what is the Food and Drug Administration (FDA)?

• the leading enforcement agency at the federal level

• regulates the safety, efficacy/effectiveness, & labeling of drugs

what is the Drug Enforcement Administration (DEA)?

the agency that controls controlled substances

what is the Food and Drug Act of 1906?

prohibits interstate commerce/trading in adulterated/misbranded food, drinks, and drugs

what is the Food, Drug, and Cosmetic Act of 1938?

• in response to the fatal food poisoning of 107 people (mainly children) due to an untested sulfanilamide concoction

• requires new drugs to prove that they’re safe before putting in market

what is the Durham-Humphrey Amendment of 1951?

• distinguishes OTC vs. legend (Rx) drugs

• legend (Rx) drugs require this label - “Caution: Federal Law prohibits dispensing without a prescription”

what is the Kefauver-Harris Amendments of 1962?

requires drug manufacturers to provide proof of both safety and efficacy/effectiveness of drug before being dispensed by pharmacies

what is the Poison Prevention Packaging Act of 1970 (PPA 1970)?

requires childproof packaging on all controlled substances and most prescription drugs

ex: blister packs & safety caps → must push/turn to open

what is the Controlled Substances Act of 1970 (CSA 1970)?

• enforced by the Drug Enforcement Administration (DEA) within the Justice Department

• classifies and restricts distribution of controlled substances

what is the Omnibus Budget Reconciliation Act of 1990 (OBRA 1990)?

requires pharmacists to offer counseling regarding medications to Medicaid patients

what is the Health Insurance Portability and Accountability Act of 1996 (HIPAA 1996)?

provides regulations to protect patients’ privacy

what is schedule I for controlled substances?

• high potential for abuse

• no accepted medical use in US

ex: MDMA (Ecstasy), heroin, LSD, methaqualone, peyote

what is schedule II for controlled substances?

• high potential for abuse

• may lead to physical/psychological dependence

• yes accepted medical use in US

ex: narcotics → codeine (>90 mg), stimulants for ADHD

what is schedule III for controlled substances?

• potential for abuse is less than schedule I and II

• may lead to low-moderate physical dependence/high psychological dependence

• yes accepted medical use in US

ex: narcotics → codeine (<90 mg), non-narcotics → anabolic steroids like depo-testosterone and ketamine

what is schedule IV for controlled substances?

• potential for abuse is less than schedule III

• may lead to limited physical/psychological dependence

• yes accepted medical use in US

ex: benzodiazepines

what is schedule V for controlled substances?

• potential for abuse is lower than schedule IV

• may lead to limited physical/psychological dependence

• yes accepted medical use in US

ex: cough, nerve pain

can C-II substances be refilled?

no

what is the refill rule for schedules III-V controlled substances?

can be refilled up to 5 times within 6 months from the date they were prescribed

what is DEA Form 222?

for ordering C-II substances

what is DEA Form 106?

for reporting theft/loss of controlled substances

what is the Combat Methamphetamine Act (CMEA)?

• requires all pharmacies to keep all OTC cold and allergy meds containing ephedrine, pseudoephedrine, or phenylpropanolamine BTC (behind the counter)

• ephedrine and pseudoephedrine restrictions:

  • 3.6 g per day

  • 9 g per month

  • 7.5 g thru mail

• must keep records of purchaser for 2 years

what is the Risk Evaluation and Mitigation Strategies (REM)?

• drug program to ensure patients safely use drugs w/ known risks or serious adverse effects

• enforced by the FDA

what is Risk Minimization Action Plans (RiskMAPs)?

drug program that focuses on specific safety concerns of a specific med

what is the FDA Amendments Act of 2007?

establishes requirements for Risk Evaluation and Mitigation Strategy (REM) for manufacturers

what are the 3 classes of recalls?

recalls:

• class I recall: strong likelihood that product will cause serious adverse health effects/death

• class II recall: product may cause temporary, but reversible adverse health effects or little likelihood that it may cause serious adverse health effects

• class III recall: not likely that product will cause adverse health effects

who can initiate recalls?

• manufacturer

• distributor

• FDA

are recalls voluntary or mandatory?

voluntary

what must the manufacturer do when they initiate a recall?

develop a recall strategy for the actions that will be taken:

• find issue w/ product

• notifying affected parties

• correct issue

wat is the difference between a correction recall and a removal recall?

• correction - fixing/correcting issue of product

• removal - removing product from market

what is the NDC (National Drug Code) Number?

• number for identifying a drug

• 3 parts:

  • 1 - indicates manufacturer

  • 2 - indicates med, its strength, and its dosage form

  • 3 - indicates package size

what is the DEA number?

• number assigned to all the prescribers of controlled substances

• 2 letters followed by 6 numbers

what is Medwatch?

• drug reporting program for health-care professionals to report adverse health effects that happen from the use of approved drug/medical product

• enforced by FDA

how are controlled substances and their records stored?

• C-II records: kept separate from non-controlled substances & other controlled substances

• C-III to C-V: kept w/ each other and can be w/ non-controlled substances

where are controlled substances stored?

• C-II substances: in a locked, tamper-proof narcotics cabinet usually secured to the floor/wall

• C-III to C-V substances: kept openly on a shelf

what are the 3 copies of DEA Form 222?

• copy 1: supplier keeps

• copy 2: forwarded to DEA

• copy 3: # containers and dates of drugs received

how many years are the 3 copies of DEA Form 222 kept?

2 years

what are the dispensing regulations for controlled substances?

• pharmacies that dispense controlled substances must be registered w/ DEA using DEA Form 224

• partial dispensing is allowed, but the remaining quantity must be dispensed to patient within 72 hours

what are the transferring regulations for controlled substances?

• C-III to V can be transferred between pharmacies

• C-II cannot be transferred between pharmacies unless in emergency situations w/ proper documentation

what is DEA Form 41?

for reporting damaged controlled substances

what is the Drug Listing Act?

established NDC’s

what does the Orange Book include?

therapeutic equivalence

what does the Pink Book include?

epidemiology and vaccine-prevented diseases

what does the Purple Book include?

biological drug products or biosimilars

what does the Red Book include?

drug pricing

what does the Green Book include?

veterinary medicine

what is DAW code?

“Dispense As Written”

• codes:

  • 0 - no preference

  • 1 - doctor wants patient have branded drug

  • 2 - patients wants branded drug