Exam 4 - Law Flashcards
FDA pregnancy and lactation labeling
Still use the A, B, C, D, X categories
OTC products are not affected by the new FDA pregnancy and lactation labeling
Age restriction for emergency contraception
NONE
You do NOT have to have an ID to purchase
OTC labeling for vaginal contraceptive and spermicide use containing nontoxynol 9 as the AI
STD alert: this product does not protect against HIV/AIDS or other STDs and may increase the risk of getting HIV from an infected partner
Where are emergency contraceptives kept
Often kept behind the counter
FDA requests that it be kept w/ family planning section w/ the condoms
Who may purchase emergency contraceptives
Males and females may purchase
OTC labeling special warning requirements of mineral oil
Requires warning to only be taken at bedtime and not to be used in infants unless under advice of physician
Plan-B One Step
Single pill of 1.5 mg levonorgestrel
What happens if you use mineral oil during pregnancy
It predisposes the newborn to hemorrhagic diseases
Plan B restrictions
Currently no states restrict the sale of Plan B
May change due to overturning of Roe v Wade
Why can you not use mineral oil near meal time
It interferes w/ absorption of fat soluble vitamins and provitamin A
OTC labeling for mineral oil cannot
Encourage use during pregnancy
What happens when mineral oil is given to infants?
The infant is at greater risk of aspiration and lipoid pneumonia
Sodium phosphates
Saline laxative used PO and as a rectal enema
Limits for sodium phosphate oral solution
Not more than 90 mL per OTC container and has additional specific warnings
Effect/use of PSE
Precursor to meth
How are sodium phosphates ALSO marketed
As rx products (OsmoPrep) and are used for bowel cleansing prior to colonoscopy
Legislative/regulatory action of PSE
Combat Meth Act of 2005
OTC products of abuse
Class v controls (cough syrup)
Antihistamines (dimenhydrinate)
Laxatives
Loperamide
Dextromethorphan
Pseudoephedrine
(CALL Da Police)
Why are sodium phosphate products limited w/ specific warnings?
Due to the risk of using to much
It can cause severe changes in hydration and electrolytes, resulting in:
- harm to kidney
- harm to heart
- death
Effect/use of dextromethorphan
Intoxication
Altered mental status
Legislative/regulatory action of dextromethorphan
Many products have been reformulated to omit abuse
Effect/use of class V controls (cough syrup)
Opioid abuse
Effect/use of laxatives
Anorexia
Cause electrolyte imbalances and GI complications
Legislative/regulatory action of laxatives
NONE
Effects/use of loperamide
Used to stop diarrhea from opioid withdrawal
May cause:
- QT/QRS prolongation
- Cardiotoxicity
- Arrhythmias
Legislative/regulatory action of loperamide
NONE
Local stores were putting it in anti-theft packages
Effects/use of OTC antihistamines (dimenhydrate)
Intoxication and stimulant-like effects
Euphoria and hallucination
Legislative and regulatory action of OTC antihistamines (dimenhydrate)
NONE
(T/F): the ABCDX pregnancy categories have been removed completely from all FDA approved products
False
(T/F): drugs are not impacted by the new FDA pregnancy/lactation category labeling
True
Sodium phosphate oral solutions are limited to not use more than ____ mL per OTC container
90 mL
Which categories replaced the ABCDX pregnancy categories
- Females and males of reproductive potential
- Pregnancy
- Lactation
(T/F): there are no controlled substances available for OTC purchase
False
PSE is a _____ in WV
C5
