Law Review

Question 1

Pure Food and Drug Act of 1906

Answer 1

• Prohibited food/medication from being misbranded or adultered
• False/incorrect claims of efficacy weren’t prohibited, labeling wasn’t regulated, and safety didn’t have to be proven
• Only addresses contaminated and inappropriately labeled foods/medications

Question 2

Harrison Narcotics Tax Act of 1914

Answer 2

• Passed to regulate opium and narcotic use
• Required prescription for opium to be given to patients and for prescribers to be registered to prescribe opium
• Had to document scripts for opium

Question 3

Food, Drugs, Cosmetics Act of 1938

Answer 3

• Used to try and correct pitfalls from Pure Food and Drug Act of 1906
• Established the FDA and said that they had to approve all new medications being sold in US
• Not approved until they are proven safe
• Established that adulteration and misbranding were illegal and required adequate instructions and warnings be included on medication labels
• Required quantities of active ingredients, alcohol content, and name/location of manufacturer

Question 4

Durham-Humphrey Amendment of 1951

Answer 4

• Established two classes of medication, OTC and Rx
• Rx meds were allowed to have prescriber’s directions for use on the label if they had the following warning: “Caution: Federal law prohibits dispensing without a prescription”
• Allowed scripts to be called in over the phone and allowed for refills as well

Question 5

Kefauver-Harris Amendment of 1962

Answer 5

• Drugs must be proven to be effective in addition to being pure and safe
• Followed the thalomid tragedy
• Retroactively applied to drugs approved between 1938-1962
• Gave FDA authority to oversee med advertising and established good manufacturing practices (GMP) for drug manufacturers
• Also more control over clinical trials, participants were required to have informed consent

Question 6

Comprehensive Drug Abuse, Prevention, and Control Act of 1970

Answer 6

• AKA Controlled Substances Act
• Regulations on prescribing, dispensing, importation, possession, and use of controlled substances
• Required dispensing facilities to register with DEA with DEA form 224 every 3 years
• Established the five controlled substance classes that decrease in abuse potential/dependence as the classes increase

Question 7

Ordering Controlled Substances

Answer 7

• Complete DEA 222 form in writing
• Must retain a copy, send other two to wholesaler who then sends one to the DEA
• Must acknowledge that the medications were received on the DEA 222 kept at the pharmacy and retain those records for at least 2 years

Question 8

Maintaining DEA Records

Answer 8

• All kept for a minimum of two years, longer based on state law
• Defective and incorrectly filled out DEA 222 should be kept too
• Check record keeping requirements per state, varies widely

Question 9

Controlled Substance Inventories

Answer 9

• Must conduct controlled substance inventories on a regular basis
• One before pharmacy ever opens, then biennially thereafter
• Exact counts must be done for CII and estimated counts for CIII-V in packages <1000
• Keep records of these inventories for at least 2 years
• Perpetual inventory of CII must be utilized, all additions and subtractions from controlled substance inventory should be recorded as they occcur

Question 10

Returning Controlled Substances

Answer 10

• DEA 222 needs to accompany any transfer of CII
• Keep record in receiving and transferring pharmacy
• Send green copy to DEA within 60 days of transfer

Question 11

Destroying Controlled Substances

Answer 11

• Damaged or outdated controlled substances need permission to be destroyed be submitting a DEA 41
• Include date of destruction, name, concentration/quantity of controlled substance, method used for destruction, and names of witnesses
• Must be sent to DEA at least two weeks before destruction
• Hospitals can apply for “blanket authorization”

Question 12

Controlled Substance Theft

Answer 12

• Must inform closest DEA diversion office and submit a DEA 106
• Include DEA registration information, purchase value of products, name/dose/quantities
• Send original copy to DEA and keep a copy at pharmacy

Question 13

Emergency Filling Controls

Answer 13

• Faxes okay for terminally ill
• Some Schedule Vs can be bought without a script
• Requirements: only done by pharmacist, min 18 y.o., keep records of identification with details of transaction, no more than 240mL/48 dosage units of opiate based products and 120mL/24 dosage units of other controlled substances within 48 hours

Question 14

Poison Packaging Act of 1970

Answer 14

• Goal: Decrease accidental poisoning of children
• OTC and most Rx should have child resistant containers
• Exceptions include if patient requests EZ open, doctor requests EZ open, or if OTC warn “This package for households without young children” OR “Package not child resistant”

Question 15

OSHA of 1970

Answer 15

• Ensured employees had a right to a safe/healthy work environment
• Developed employee health and safety standards
• Reduced hazardous working environments and could audit workplaces to ensure they remained compliant
• Safety data sheets and guidelines for cytotoxic drugs

Question 16

Drug Listing Act of 1972

Answer 16

• Created NDCs
• First five: manufacturer, Next four: specific drug, Last 2: package size/type
• Used to differentiate products

Question 17

Orphan Drug Act of 1983

Answer 17

• Orphan drugs treat conditions that effect <200,000 people worldwide
• Tax incentives for companies to produce orphan drugs
• Also gave exclusive licensing rights for 7 years after approval
• Research assistance and grants also made available

Question 18

Drug Price Competition and Patent Term Restoration Act of 1984

Answer 18

• AKA Hatch-Waxman Amendment
• Streamlined a generic drug approval process to encourage their development
• Abbreviated new drug application made to decrease time to approval from FDA
• First generic to file ANDA got exclusive marketing rights for 180 days before other manufacturers

Question 19

Prescription Drug Marketing Act of 1987

Answer 19

• Solidify drug chain of Rx meds
• Reinforce standardized routes that drug products follow from wholesaler to pharmacies
• Help prevent counterfeit products from entering supply
• Prevented hospitals from reselling medications to outside businesses
• No dispensing samples unless you were licensed to prescribe the meds

Question 20

FDA Modernization Act of 1997

Answer 20

• Streamlined FDA’s regulatory process to more rapidly approve drugs
• Aimed to reduce backlog of medications in approval process
• Fast-tracked approval for meds for life-threatening conditions, database of clinical trial information, and expanded rights to give information on unlabeled uses of drugs
• Increased FDA oversight of OTCs and required inactive ingredients to be listed as well

Question 21

OBRA of 1987

Answer 21

• Addressed the quality of healthcare received by elderly under Medicare
• Standards of care for those living in nursing homes were established
• Prevented use of medications that were not necessary for the patients’ conditions and established requirements for antipsychotic use
• Nursing homes must be serviced by a consulting pharmacist

Question 22

Anabolic Steroid Control Act of 1990

Answer 22

• Regulations for anabolic steroids and punishments for abusing/misusing these products
• “Any medication chemically related to testosterone”
• Set aside money to educate about their harmful effects
• Moved them to CIII status

Question 23

OBRA-90

Answer 23

• Drug utilization evaluations must be completed before filling a drug
• Must check for CI, DDI, dosage accuracy, and treatment duration
• Established a need for patient counseling
• Right to refuse counseling, use professional judgement on what to include in counseling

Question 24

DSHEA of 1994

Answer 24

• Regulations for herbal products
• List ingredients and quantity of each ingredient as well as plant or part of plant used to make product
• Must also state that the product is a dietary supplement
• Meet standards for purity, quality, composition, and production to comply with standards
• Good manufacturing practices and prevent adulteration of products

Question 25

DATA of 2000

Answer 25

• Broaden rights of prescribers to prescribe controlled substances to treat opiate addiction (DEA registration)
• CIII-V use for patients undergoing detox or for maintenance of opiate addiction
• Buprenorphine included, not methadone
• Patients must enroll into a program with support services and counseling

Question 26

MPDIMA of 2003

Answer 26

• Modernized Medicare system
• Added prescription drug benefit to Medicare (Part D)
• Medicare Advantage program for low-income Medicare patients for additional cost savings

Question 27

Isotretinoin Safety and Risk Management Act of 2004

Answer 27

• Acne med that causes birth defects
• Established REMS program where patients and prescribers had to register and be approved for monthly refills
• Restricted to 30 day fills
• Pregnancy tests required monthly before getting additional medication

Question 28

Combat Meth Epidemic Act of 2005

Answer 28

• Limited meth ingredients to specific amounts
• 3.6 g per day and 9 g per 30 days
• Pseudoephedrine, ephedrine, and phenylpropanolamine

Question 29

Medicaid Tamper-Resistant Prescription Act

Answer 29

• Handwritten scripts for Medicaid patients must be on tamper resistant paper
• To stop modifying or erasing parts of prescriptions
• Fax is an option if tamper resistant paper isn’t available

Question 30

USP <797>

Answer 30

• Reinforced regulations for sterile products
• Created requirements for aseptic techniques and requirements for facilities that make, store, or dispense sterile products
• Required training/evaluation for all personal who involved in compounding
• Classifications for air cleanliness and construction of sterile compounding rooms as well