Compounding & OTC Products Flashcards
pg. 213-217 Chapter 8: Compounding Laws and Rules
Does the state have stricter requirements for compounding than federal requirements?
No
What requirements must be met before an out-of-state pharmacy can compound drugs for dispensing to patients in this state (e.g., inspections, permits, fees)?
A non-resident pharmacy engaged in the compounding of sterile preparations must be licensed as a Class E-S pharmacy.
A Class E-S pharmacy may not renew a pharmacy license unless the pharmacy has been inspected by the board or its designee within the last renewal period.
What are the additional label requirements for compounded products?
Must have the following information (in addition to general label requirements):
1) Drug name for each active ingredient
2) A statement that this product has been compounded by the pharmacy
3) Beyond-use-date
Does the state allow pharmacists to furnish emergency contraception?
No
What are the requirements and quantity limits for selling pseudoephedrine?
An individual must be ≥ 16 years old to purchase
Products must be stored behind the counter or in locked case within 30 feet and in direct view of a counter staffed by an employee
Cannot purchase > 3.6 g in one day or > 9 g in 30 days
Does the state require the submission of pseudoephedrine sales to NPLEx?
Yes, it must be submitted before completing the sale; if the system fails, another tracking system should be used until the system is available again, or the retailer may refrain from ephedrine or pseudoephedrine-containing products.
What are the requirements for selling dextromethorphan?
The purchaser must be ≥ 18 years old
Does the state require a prescription for syringes and needles?
No
Does the state set a limit on the maximum number of syringes that can be purchased without a prescription?
No
Does the state allow syringe exchange programs?
No
