Food, Drug, and Cosmetic Act Flashcards
Which act required new drugs to be proven safe?
Food, drug, and cosmetic act
Which act provided a distinction between prescription and OTC drugs?
Durham-Humphrey Amendment of 1951
Which act made manufactures print on prescription drugs “Federal law prohibits dispensing without a prescription”?
Durham-Humphrey Amendment of 1951
Which act made drugs be proven safe AND effective?
Kefauver-harris act
What are the federal requirements for labeling of prescription drugs?
-Patient name
-Prescription number
-Date when prescription written or dispensed
-Name of prescriber
-Name and address of the pharmacy
-Cautionary statements
What did the Food, Drug, and Cosmetic Act of 1938 do?
Requires new drugs must be proven safe.
Defined what a new drug was approved for human use.
Required adequate use instruction and warnings for abuse.
What did the Durham-Humphrey Amendment of 1951 do?
- Created a distinction between “OTC” and “Legend Drugs”
- Legend Drugs can only be dispensed with a valid Prescription and by an authorized person
- Allowed prescribers to authorize refills and oral scripts
- The emphasis on this act was to insure safety thru qualified medical supervision.
- Made manufacturers print on label: “Federal law prohibits dispensing without a prescription”
What are the patient label requirements in louisiana?
1) Patient name
2) Prescriber name
3) Pharmacist initials/name
4) Pharmacy name, address, and phone #
5) Medication: Name, Strength, directions, RX #, Date dispensed, and warnings
What did the poison prevention act of 1970 do?
Special packaging for medications were now required to make is difficult for not more than 20% of children to open but not more than 10% of adults can not use
Who can make exclusions to the poison prevention act?
- A prescriber can make a one time exclusion
- The pharmacist can not make an exclusion
- The patient can make single or blanket exclusions
What are the medications excluded from the poison prevention act?
- Nitroglycerin SL
- Isosorbide dinitrate SL 10 mg or less
- Erythromycin ethylsuccinate (EES) granules: not more than 8 grams
- Erythromycin ethylsuccinate tablets: not more than 16 grams
- Cholestyramine powder
- Potassium supplements
- Betamethasone tablets
- Prednisone
- Sodium fluoride
- Mebendazole tab
- Methylprednisone
- Colestipol
- Pancrelipase
- Cyclically PO contraceptives
- conjugated estrogen tabs
- Norethindrone acetate tabs in mnemonic dispenser
- medroxyprogesterone acetate tabs
- sacrosdiase
Products that have proof they are ok start with _.
A
This means they are substitutable for something else, data exists and meets bioequivalence
AA
Products in conventional dosage forms
AN
Solutions and powders for aerolization
AO
Injectable oil solutions
AP
Injectable aqueous solutions and certain IV non-aqueous solutions
AT
Topical products
Products that are not suitable for generic products start with _.
B
They require further FDA investigation and review to determine equivalency
BC
Extended release dosage forms
BD
Active ingredients and dosage forms with documented bioequivalence problems
BE
Delayed release oral dosage forms
BN
Aerosol-neb
BP
Active ingredients with POTENTIAL bioequivalence problems
BR
suppositories or enemas
BS
Products having drug standard deficiencies
BT
Topical with bioequiv issues
BX
drug products where data are insufficient to determine equivalence
How long does a patent last?
20 years
What is the duration of market exclusivity of a generic drug patent?
180 days
Can you continue to refill an OTC after the refills go away?
Yes, but if the directions are above the OTC labeling, you take responsibility
What are the requirements for OBRA 90?
DUR
Counseling
Patient medication histories
What must you counsel on?
1) Name and description of medication
2) Dosage form, dose, route, and duration of therapy
3) Special directions for preparation, administration, or use by patient
4) Common severe SEs, adverse effects, interactions, or CIs
5) self-monitoring techniques
6) Storage and refill info
7) What to do if dose missed
What should patient medication use histories include?
1) Name, address, phone number, age, DOB, gender
2) Significant disease states
3) known allergies or prior drug reactions
4) list of drugs and devices previously used by patient
5) pharmacist’s comments relevant to individual’s therapy
What is the difference between adulteration and misbranding?
Adulteration is when a drug contains filthy, putrid, or decomposed substance (contains unapproved drug, color additive, or deleterious substance). It is prepared in unsanitary conditions.
Misbranding is when the labeling is false or misleading. It’s missing data like manufacturer, active drug, missing quantity.
What are the labeling requirements for manufacturers?
1) Name and address of manufacturer
2) Established name of product
3) “net” quantity
4) Weight of each active ingredient
5) Federal legend
6) Specific route
7) Storage requirements
8) Manufacturer Lot #
9) Expiration date
Aspartame warning
Phenylketonuric
Sulfite
Preservative- allergy
Sodium phosphate warning
No more than 90 ml per container
Isoproterenol inhalation warning
Call doc if symptoms persist
Acetphenetidin warning
long time dosing kills your kidneys
What are the restricted access programs for some medications?
1) Thalidomide - STEPS
2) iPLEDGE
3) Lotronex -PPL
4) Clozaril - CNR
5) Xyrem
What are the regulations for thalidomide?
7 days post preggo test or 30 days for males
the scripts are good for 28 days
WRITTEN Rx
What are the regulations for Isotretinoin?
- Escribed or phoned in
- Registration in database
- 2 forms of BC
- Monthly preggo tests
- 30 day limit on Rx
- Need authorization number prior to filling
What are the regulations for clozapine?
- Blood drawn first 6 months weekly
- Next 6 months is every 2 weeks
- After that it is once a month
What programs use specialty pharmacies?
- Exjade
- Fosamax for pagets
- IRESSA (Gefitinib)
- Xyrem
What is a class I recall?
Reasonable probability that the product will cause serious illness or death
What is a class II recall?
Reasonable probability of temporary or reversible adverse events, death is unlikely
What is a class III recall?
are not likely to cause adverse health consequences
Does the FDA have authority to regulate compounded drugs?
Yes because they are considered new drugs
What are the BUDs in the absence of stability data?
Non aq liquids: time left of soonest ingredient or 6 months
Aq solutions: 14 days at cold temp
Everything else: duration of therapy or max 30 days
What is a low risk sterile product?
made using closed system transfers
What is a high risk category I sterile product?
Made with complex procedures or mult procedures
What is a category II product?
non-sterile agents used or open systems
What are the rules of regulation for HIPAA?
Keep for six years.
Patient should sign only on the first time and a third party may sign.
Privacy policies must be posted somewhere.
Where should you not disclose patient info?
Mailings or phone calls
Are foreign prescriptions allowed for controlled substances?
No but it could be allowed if the foreign prescriber had a US DEA registration
