The Pharmacy Flashcards
Who can access a the pharmacy without a pharmacist?
Pharmacy must be under immediate supervision and management of a licensed RPh at all hours when open
BOP & BOE may enter any pharmacy at reasonable times for inspection
minimum square footage
300 sq ft
at least 100 sq ft dedicated to manufacturing, compounding and dispensing
minimum counter space
none specified
counseling area requirements
none specified
Security system requirements
Walls must be floor to ceiling or at least 9’6” high
Storage requirements: drugs
- adequate heating & ventilation
- community pharmacies may keep controlled substances dispersed throughout their inventory
Storage: hard copy Rx
separate storage for
- C2
- C3/4/5
- non-controls
- system shall provide adequate safeguards against improper manipulation or alteration of stored records”
- must be kept on site, readily available for 5 years
Signage requirements
Drug retail list available upon request
Chain pharmacies with 8 or more locations only:
- language assistance services
How soon does the board need to be notified on changes in pharmacy ownership?
within 30 days of change
Also applies to:
- changes in officers of a corporation
- change in stockholders holding 10% or more
PIC change, how long to notify the board?
Owner must notify within 7 days of change.
Change of address, when must the board be notified?
at least 30 days prior to expected relocation.
Change in hours, when must the board be notified?
none specified, go nuts
Equipment requirements
- Class A balance (6mg)
- devices capable of measuring volumes from 0.1 to 500 mL
- mortar & pestle
- refrigerator with a thermometer, kept at 2-8 degrees C
- copy of NYS pharmacy laws
- hot and cold running water in pharmacy compounding/dispensing area
Out of state mail order registration
- must be licensed and/or registered with their home state
- Register with NY as a non-resident establishment
Mail order: communication requirements for patient questions
must provide a toll free number during normal business hours at least 40 hrs/week for communication between patient and pharmacist
what is a resident agent in regard to out of state mail order pharmacy?
a required designee for the company in NYS to receive notice of laws
Non-resident establishments (mail order, manufacturers, wholesalers) may be exempt from registration requirements if……
Mail order:
- dispense 600 or fewer Rx/year to NY
Manufacturers & wholesalers:
- make < $10,000 in sales to NY per year
Requirements for NY based mail order to send Rx to other states?
no specific language, default to receiving state regulations
Fees for a pharmacy (building) license?
Application: $345
Renewal: $260
Endorsement (Relocation): $50
Requirements for an owner to apply for a pharmacy license:
Good moral character
Corporate applicants
- all
officers/directors/stockholders having 10% or greater interest in the company must also be of good moral character
Do you need to be a RPh to own a pharmacy
No, but if the owner is not an RPh, they must have a licensed Supervising Pharmacist on the registration
Pharmacist in charge (PIC) aka supervising pharmacist requirements:
full time employee (30 hrs min)
- or majority hours of operation if not open 30 hrs/week
only 1 PIC per pharmacy
If drugs are to be sold at auction when must the board be notified?
at least 7 days prior
Fee for name change/ renovation/ owner change?
Nah
Change of PIC: when must the board be notified
Owner must notify board within 7 days
Damage by fire/disaster/flood: when must the board be notified
within 48 hrs
Pharmacy signage requirements:
- Sign bearing full name of owner prominently displayed on exterior of premises
- Registration must be conspicuously displayed at all times inside the pharmacy (if PIC changes owner must apply for amended registration to display)
Preceptor to intern ratio
1 pharmacist may supervise only 1 full time OR 2 part time interns at a time
Rx per year : # of interns allowed
Must dispense 5,000 Rx yearly per intern
interns do not contribute to the RPh : Pharm Tech ratio.
