PTCB PREP: FEDERAL REQUIREMENTS

what is the Food and Drug administration?

• the leading enforcement agency at the federal level

• regulates concerns relating to drug products

what is the Drug Enforcement Administration?

the agency that controls the distribution of drugs that may be easily abused

how many main federal pharmacy laws are there?

8

what is the Food and Drug Act of 1906?

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

• government approval of drugs is required before interstate commerce/trading

what is the Food, Drug, and Cosmetic Act of 1938 (FDC)

• 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 effectiveness of drug before being dispensed by pharmacies

what is the Poison Prevention Packaging Act of 1970?

requires childproof packaging on all controlled and most prescription drugs dispensed by pharmacies

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

• classifies restricts distribution of drugs that may be easily abused

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

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

requires pharmacists to offer counseling regarding medications to Medicaid patients

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

provides regulations to protect patients’ privacy

what is schedule I for controlled substances?

• high potential for abuse

• no accepted medical use in US

what are 3 examples of schedule I controlled substances?

• heroin

• various opium derivatives

• hallucinogenic substances

what is schedule II for controlled substances?

• high potential for abuse

• may lead to physical/psychological dependence

• yes accepted medical use in US

what are 5 examples of schedule II controlled substances?

• amphetamines

• opium

• cocaine

• methadone

• various opiates

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

what are 2 examples of schedule III controlled substances?

• anabolic steroids

• various compounds containing limited quantities of narcotic substances like codeine

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

what are 3 examples of schedule IV controlled substances?

• phenobarbital

• sedative chloral hydrate

• anesthetic methohexital

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

what is 1 example of schedule V controlled substances?

compounds containing limited amounts of narcotic like codeine

what 3 things must be on controlled substance prescriptions?

• DEA number

• patient’s full street address

• prescriber’s signature

what are the 2 limits to schedule II controlled substances?

• quantities are limited

• no refills

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

can be refilled up to 5 times within 6 months

what is the NDC (National Drug Code) Number?

• number assigned by manufacturer

• 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

are recalls mandatory (w/ exceptions) for manufacturer?

yes

what are the 3 classes of 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

what is Medwatch?

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

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 written/electronic records of purchaser for 2 years

what 6 info of purchaser is kept as required by CMEA?

• product name

• date and time sold

• quantity sold

• purchaser’s proof of identification

• purchaser’s name and address

• purchaser’s signature

what are the labeling regulations for controlled substances?

manufacturers must clearly label controlled substances w/ their control classification

what are the receiving regulations for controlled substances?

• distributors are required to maintain accurate records of controlled substance activity (inventory and dispension)

• schedule II controlled substance records kept for 7 years, while other schedules kept for 2 years

• schedule II controlled substance records kept separate from non-controlled substance records, but may be kept w/ other controlled substance records

what are the storing regulations for controlled substances?

• C-II stored in locked, tamper-proof narcotics cabinet usually secured to floor/wall

• other schedules kept openly on storage shelves

what are the ordering regulations for controlled substances?

DEA form 222:

• used to order C-I and C-II controlled substances

• 3 copies

what are the regulations for each copy 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 copies of DEA form 222 kept on-hand?

2 years

what is the FDA Amendments Act of 2007?

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

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

• info and procedure for patients to safely use drugs w/ known risks

• required for manufacturers by FDA

what are the dispensing regulations for controlled substances?

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 pharmicies

• front of prescription includes:

  • “void”

• back of prescription includes:

  • receiver’s DEA number

  • receiving pharmacist’s name

  • name and address of pharmacy

  • receiving pharmacist’s name