Behind the counter Flashcards
Legend drug
prescription drug
defined as Rx only under FDA Modernization Act of 1997
Durham-Humphrey Amendment of 1951
First time a clear distinction was made between OTC & Rx drugs
3 conditions that would make a drug prescription only:
- habit forming
- unsafe except under expert supervision due to toxicity concerns
- limited to prescription use only under a manufacturers new drug application
Which drugs are required to be behind the counter?
Ephedrine
Pseudoephedrine
Phenylpropanolamine
Documentation requirements for behind the counter drugs (pseudoephedrine, etc.)
Product name
Quantity sold
Names + addresses of purchasers
Date & time of sale
Signature
Must maintain records for at least 2 years
Max quantities of behind the counter meds (pseudoephedrine, etc.)
3.6 grams/day
9 grams/30 days
Mail order: 7.5 grams/30 days
Can syringes be dispensed without a prescription?
Providers must register to sell needles or accept needles/syringes for the purpose of disposal
- may sell to 18 yrs or older
Sale should include a safety insert which includes:
- info on proper use of hypodermic syringes/needles
- risk of blood borne disease
- methods for preventing transmission or contraction of BBD
- proper disposal practices
- dangers of injection drug use and how to access drug treatment
- toll-free # for info on HIV. CDC’s hotline: 1-800-CDC-INFO (232-4636)
- statement that it is legal for persons to possess syringes obtained pursuant to article 33 of the Public Health Law
Advertising for non-Rx syringes
Not allowed
syringes must be kept behind the counter
Logging requirements for non-Rx syringe sales
none
Prescription syringes regulations
Oral Rx allowed for syringes
Rx valid for 2 years in NYS
No regulations on number of refills a prescriber can authorize
How old does someone have to be to purchase pseudoephedrine?
16 years old
