Pharmacy (the actual building) Flashcards
When do the state BOP, DOE, & their employees have the right to enter a pharmacy
at any reasonable time for inspection
Minimum sq footage requrements
300 sq ft
w/ at least 100 sq ft dedicated to manufacturing, compounding, & dispensing
Wall requirements
for security purposes, walls must be floor to ceiling or at least 9’6” high
Proper storage of prescription hard copies for controlled substances
File hard copies separately in 3 groups
- C2 prescriptions
- C3-5 prescriptions
- Non-controlled prescriptions
Requirements for storage, lighting, water etc.
Pharmacy must have storage facilities ensuring the safe storage of drugs
Must have:
- heating & ventilation adequate to safeguard the purity and potency of drugs
- adequate lighting
- hot and cold running water in the compounding & dispensing area
Security of hard copy prescription storage? Do storage areas need to be locked for hard copies?
“System shall provide adequate safeguards against improper manipulation or alteration of stored records”
Do hard copies of prescriptions need to be stored on site?
How long do they need to be stored?
Hard copies must be stored on premises & readily available
Must be stored for 5 years
Same rules for CS & Non-CS
Is signage required for pharmacy hours?
Generally none specified
BUT, if the pharmacy is not open during at the same times the rest of the store/establishment is open, an exterior sign must indicate when the pharmacy is open
Required signage in the pharmacy
- Registration
- Name of owner(s) of a pharmacy shall be conspicuously displayed upon the exterior of the establishment
- If the owner is not a licensed pharmacist, a LP with personal supervision of the facility must also be listed on the registration
- Drug retail price list
- Language assistance service signage
What is the timeframe for notifying the BOP to changes in pharmacy ownership
Within 30 days of change in ownership
this also applies to changes in officers of corporation or in stockholders holding 10% or more of stock in the corporation
Timeframe to notify the BOP of changes to the PIC (pharmacist in charge)
PHARMACY OWNER must notify BOP within 7 days of the change
Does the BOP need to be notified of changes to pharmacy hours?
no specified requirement
How soon does the BOP need to be notified if a pharmacy is having an auction
at least 7 days prior
How soon does the BOP need to be notified if a pharmacy wants to dispose of controlled substances?
at least 2 weeks prior
Equipment requirements:
Prescription balance
Class A balance (6mg sensitivity)
+ Metric weights if needed for operation of the balance
Equipment requirements:
Everything but the balance
- devices to measure from 0.1 to 500mL
- Mortar & Pestle
- Refrigerator with thermometer storage temp 2-8C (36-46F) for storage of drugs
- Copy of laws, rules, & regulations governing practice of pharmacy in NYS
- Hot and cold running water in compounding and dispensing areas
Must a RPh be on site for access to the pharmacy?
yes
Requirements for out of state mail order pharmacies
- must register as a non-resident establishment
- must be licensed/registered with their home state in order to seek registration in NYS
- must provide toll free # during normal business hours and at least 40hrs/week for communication between patients & pharmacists
- must designate a resident agent in NYS (someone to receive notice of lawsuits)
Exemption to registration requirements for out of state mail order pharmacies
Exceptions may be granted if the MOP limits its activity in NYS to “isolated transactions”
- 600 or less Rx/year
- <$10,000 in sale for manufacturers or wholesalers in NY
- necessary to protect the public health by addressing emergency shortage of a drug/device in NYS
Pharmacy ownership requirements:
Pharmacy license fees
$345 application fee
$260 triennial registration fee
- Must be renewed on dates set by the department
$50 relocation fee
Pharmacy ownership requirements:
who can apply for a license
Anyone of good moral character
if applicant is a corporation, all officers/directors/stockholders with at least 10% interest in the corporation must ALL be of good moral character
Pharmacy ownership requirements:
Does the owner of a pharmacy need to be a pharmacist?
No
Pharmacy ownership requirements:
If the owner is not an RPh, they must have a ____
Licensed supervising pharmacist (PIC) on the registration
- PIC must be full time (30 hrs min)
- An individual can only be PIC of one pharmacy at a given time
Pharmacy ownership requirements:
Rules for sales and transfers
30 days to notify BOP after change in ownership
Must give BOP at least 7 days notice if drugs to be sold at auction
Pharmacy ownership requirements:
Fee for name change/ renovation/ owner change?
None
Pharmacy ownership requirements:
Notification period for damage by fire / flood / natural disaster
notify BOP within 48 hrs
Staffing Requirements:
RPh to tech ratio
For every 1 pharmacist there can be (at most)…
- 2 registered pharmacy techs
- 4 unlicensed persons
Interns do not count in this ratio
Staffing Requirements:
Pharmacist to intern ratio
A preceptor pharmacist may only supervise:
- 1 full-time intern
OR
- 2 part-time interns
- pharmacy must dispense 5,000 prescriptions annually per intern
Staffing Requirements:
RPh to staff ratio (clerks, delivery drivers, cashiers, etc)
No limit
