Pharmacy (the actual building)

Question 1

When do the state BOP, DOE, & their employees have the right to enter a pharmacy

Answer 1

at any reasonable time for inspection

Question 2

Minimum sq footage requrements

Answer 2

300 sq ft
w/ at least 100 sq ft dedicated to manufacturing, compounding, & dispensing

Question 3

Wall requirements

Answer 3

for security purposes, walls must be floor to ceiling or at least 9’6” high

Question 4

Proper storage of prescription hard copies for controlled substances

Answer 4

File hard copies separately in 3 groups
- C2 prescriptions
- C3-5 prescriptions
- Non-controlled prescriptions

Question 5

Requirements for storage, lighting, water etc.

Answer 5

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

Question 6

Security of hard copy prescription storage? Do storage areas need to be locked for hard copies?

Answer 6

“System shall provide adequate safeguards against improper manipulation or alteration of stored records”

Question 7

Do hard copies of prescriptions need to be stored on site?
How long do they need to be stored?

Answer 7

Hard copies must be stored on premises & readily available

Must be stored for 5 years

Same rules for CS & Non-CS

Question 8

Is signage required for pharmacy hours?

Answer 8

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

Question 9

Required signage in the pharmacy

Answer 9

• 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

Question 10

What is the timeframe for notifying the BOP to changes in pharmacy ownership

Answer 10

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

Question 11

Timeframe to notify the BOP of changes to the PIC (pharmacist in charge)

Answer 11

PHARMACY OWNER must notify BOP within 7 days of the change

Question 12

Does the BOP need to be notified of changes to pharmacy hours?

Answer 12

no specified requirement

Question 13

How soon does the BOP need to be notified if a pharmacy is having an auction

Answer 13

at least 7 days prior

Question 14

How soon does the BOP need to be notified if a pharmacy wants to dispose of controlled substances?

Answer 14

at least 2 weeks prior

Question 15

Equipment requirements:
Prescription balance

Answer 15

Class A balance (6mg sensitivity)
+ Metric weights if needed for operation of the balance

Question 16

Equipment requirements:
Everything but the balance

Answer 16

• 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

Question 17

Must a RPh be on site for access to the pharmacy?

Answer 17

yes

Question 18

Requirements for out of state mail order pharmacies

Answer 18

• 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)

Question 19

Exemption to registration requirements for out of state mail order pharmacies

Answer 19

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

Question 20

Pharmacy ownership requirements:
Pharmacy license fees

Answer 20

$345 application fee
$260 triennial registration fee
- Must be renewed on dates set by the department
$50 relocation fee

Question 21

Pharmacy ownership requirements:
who can apply for a license

Answer 21

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

Question 22

Pharmacy ownership requirements:
Does the owner of a pharmacy need to be a pharmacist?

Answer 22

No

Question 23

Pharmacy ownership requirements:
If the owner is not an RPh, they must have a ____

Answer 23

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

Question 24

Pharmacy ownership requirements:
Rules for sales and transfers

Answer 24

30 days to notify BOP after change in ownership

Must give BOP at least 7 days notice if drugs to be sold at auction

Question 25

Pharmacy ownership requirements:
Fee for name change/ renovation/ owner change?

Answer 25

None

Question 26

Pharmacy ownership requirements:
Notification period for damage by fire / flood / natural disaster

Answer 26

notify BOP within 48 hrs

Question 27

Staffing Requirements:
RPh to tech ratio

Answer 27

For every 1 pharmacist there can be (at most)…
- 2 registered pharmacy techs
- 4 unlicensed persons

Interns do not count in this ratio

Question 28

Staffing Requirements:
Pharmacist to intern ratio

Answer 28

A preceptor pharmacist may only supervise:
- 1 full-time intern
OR
- 2 part-time interns
- pharmacy must dispense 5,000 prescriptions annually per intern

Question 29

Staffing Requirements:
RPh to staff ratio (clerks, delivery drivers, cashiers, etc)

Answer 29

No limit