Pharm Law lecture 5 Flashcards
Describe the 1970 Poison prevention packaging act
Prior to 1970, unintentional posioning was the leading cause of injury of children 5 and under.
PPA required prescription drugs to be packaged in child resistant containers (CRC) also called special packaging
Describe who special packaging is targeted to in the PPPA (poison prevention packaging act)
-Targeted at kids under 5 years old
- not difficult for normal adults to access
What does child resistant mean
20% of children or less can open after 10 mins
Atleast 90% of adults can open after 10 mins
What type of drugs are required to have child resistant containers
Oral administration drugs (OTC and prescription except Oral contraceptive)
Do bulk product containers require CRC mn=anufacturing?
no, we do not give these out to pts only for pharmacy use.
If we dispense a product that needs to be in a CRC with out CRC, what is it called
Misbranded
What are some special packaging exemptions
Non oral drugs
Waivers
What are the two types of waivers that exempt special packaging
Prescription by prescription waivers- Waives CRC pakaging for the life of a single prescription
Blanket waivers- Waives CRC packaging for all products
What are some notable CPSC exemptions (Child protective screen cap)
Full list of exemption
Sublingual dosage forms of nitroglycerin.
2. Sublingual and chewable forms of isosorbide dinitrate in dosage strengths of 10
milligrams or less.
The 2025 Student’s Guide to Federal and Indiana Pharmacy Law 85
©2025 Kristin R. Villa, PharmD, MS, PhD
3. Erythromycin ethylsuccinate granules for oral suspension and oral suspensions in
packages containing not more than 8 grams of the equivalent of erythromycin.
4. Cyclically administered oral contraceptives in manufacturers’ mnemonic (memory-
aid) dispenser packages that rely solely upon the activity of one or more progestogen
or estrogen substances.
5. Anhydrous cholestyramine in powder form.
6. All unit-dose forms of potassium supplements, including individually wrapped
effervescent tablets, unit-dose vials of liquid potassium, and powdered potassium in
unit-dose packets, containing not more than 50 milliequivalents of potassium per unit
dose.
7. Sodium fluoride drug preparations, including liquid and tablet forms, containing not
more than 110 milligrams of sodium fluoride (the equivalent of 50 mg of elemental
fluoride) per package or not more than a concentration of 0.5 percent elemental
fluoride on a weight-to-volume basis for liquids or a weight-to-weight basis for non-
liquids and containing no other substances subject to special packaging.
8. Betamethasone tablets packaged in manufacturers’ dispenser packages, containing
no more than 12.6 milligrams of betamethasone.
9. Pancrelipase preparations in tablet, capsule, or powder form and containing no other
substances subject to special packaging.
10. Prednisone in tablet form, when dispensed in packages containing no more than 105
mg. of the drug and containing no other substances subject to special packaging.
11. Mebendazole in tablet form in packages containing not more than 600 mg. of the drug
and containing no other substance subject to special packaging.
12. Methylprednisolone in tablet form in packages containing not more than 84 mg of the
drug and containing no other substance subject to special packaging.
13. Colestipol in powder form in packages containing not more than 5 grams of the drug
and containing no other substance subject to special packaging.
14. Erythromycin ethylsuccinate tablets in packages containing no more than the
equivalent of 16 grams of erythromycin.
The 2025 Student’s Guide to Federal and Indiana Pharmacy Law 86
©2025 Kristin R. Villa, PharmD, MS, PhD
15. Conjugated Estrogens Tablets, USP, when dispensed in mnemonic packages
containing not more than 32.0 mg of the drug and containing no other substances
subject to special packaging.
16. Norethindrone Acetate Tablets, USP, when dispensed in mnemonic packages
containing not more than 50 mg of the drug and containing no other substances
subject to special packaging.
17. Medroxyprogesterone acetate tablets.
18. Sacrosidase (sucrase) preparations in a solution of glycerol and water.
19. Hormone Replacement Therapy (HRT) products that rely solely upon the activity of
one or more progestogen or estrogen substances.
20. Colesevelam hydrochloride in powder form in packages containing not more than
3.75 grams of the drug.
21. Sevelamer carbonate in powder form in packages containing not more than 2.4 grams
of the drug
What are general rules for packaging reuse
We can reuse glass containers with new caps
Do not reuse plastic containers
Describe the different types of recalls
Class I recall- Drug product ay cause serious adverse health consequences including death (pharmacies notify pts)
Class II- temporry/reversible effects, but probability of serious health consequences is remote
Class III- Drug product is unlikely to cause serious adverse consequences
Difference between recall and seizure
Recall is something a comapny does, seizure is something FDA/DES do. Recall= voluntary, seizure is not
What is a law that went into place after chicago murders
FDA required tamper evident packaging for OTC human drug product
Whata re these evident packaging requirements for OTC products that are seen
Must have indicators to barrier to entry, which if breached or missing can be reasinably expected to provide visible evidence to consumers that tampering has occured.
Product must be distinctive by design and not duplicated by common materials
Tamper evident features must be described on package
A controlled substance medication is found not to have a description of tamper evident features described on its packaging. It is removed from market by its manufacturer. WHat type of recall is it
Class III
Label vs Labeling definition
Label- Any printed written or graphic material on product container
Labeling- All labels and written, printed or graphic material on container, container wrapper or accompanying product
A label is part of the labeling.
Labeling also includes anything accompanying the product, including advertisements and spoken words by drug representatives
If a drug on a shelf does not have a package insert (PI) is it misbranded or adulterated
Misbranded
PI are for healthcare professionals, not required to give patient
WHat are the 3 sections related to reproduction found on labeling
Pregnancy
lactation
Female and male reproductive potential
Do we have to give a patient a PI? PPI?
Not PI, but definitely a PPI (patient package insert)
Failure to give out a PPI to a patient results in
Misbranding
What are the only drugs requiring PPIs to be handed to patients
Estrogens and oral contraceptives
What are med guides? When must they be provided
FDA approved labeling written in pt friendly language that explains issues related to drug or drug class.
Must be provided with new and refill prescriptions for patients in an outpatient environment
Should med guides be given under direct supervision of healthcare professional?
No
Failure to dispense a medguide with a required drug is
Misbranding
When are medguides required
-Labeling could prevent serious adverse effects (SSRI)
- Serious risks of use exist which pts should be aware of
- Patient adherence to directions is crucial to drug effectiveness
What is REMS? WHat is it used for?
Risk evaluation and mitigation strategy.
Used to address serious risks associated with using a medication
What are the 4 strategies for REMS
- Patient friendly labeling
- med guides and PPIs to provide essential info about drugs - Communication plans
- Information sent directly to healthcare practitioners informing them about the drug and how to mitigate issues for patients - Elements to assure safe use (ETASU)
- Required activities must be done before prescribing, dispensing or receiving a product. Can be required from practitioners, patients or pharmacies - Implementation system
- a quality assurance process to ensure risks are being mitigated successfully
What are all OTC products required to have?
A drug facts section which includes
Active ingredients
Purpose
Use
Warnings
Directions
Inactive ingredients
Other info
For an OTC produtc, If there is no expiration date on the label what do we do
Drug should be considered expired three years after purchase
What do pharmacists HAVE to do lawfully as it pertains to Medwatch
Pharmacies must provide patients with notification of a toll free number so that they can report adverse events
