The Pharmacy

Question 1

Who can access a the pharmacy without a pharmacist?

Answer 1

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

Question 2

minimum square footage

Answer 2

300 sq ft

at least 100 sq ft dedicated to manufacturing, compounding and dispensing

Question 3

minimum counter space

Answer 3

none specified

Question 4

counseling area requirements

Answer 4

none specified

Question 5

Security system requirements

Answer 5

Walls must be floor to ceiling or at least 9’6” high

Question 6

Storage requirements: drugs

Answer 6

• adequate heating & ventilation
• community pharmacies may keep controlled substances dispersed throughout their inventory

Question 7

Storage: hard copy Rx

Answer 7

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

Question 8

Signage requirements

Answer 8

Drug retail list available upon request

Chain pharmacies with 8 or more locations only:
- language assistance services

Question 9

How soon does the board need to be notified on changes in pharmacy ownership?

Answer 9

within 30 days of change

Also applies to:
- changes in officers of a corporation
- change in stockholders holding 10% or more

Question 10

PIC change, how long to notify the board?

Answer 10

Owner must notify within 7 days of change.

Question 11

Change of address, when must the board be notified?

Answer 11

at least 30 days prior to expected relocation.

Question 12

Change in hours, when must the board be notified?

Answer 12

none specified, go nuts

Question 13

Equipment requirements

Answer 13

• 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

Question 14

Out of state mail order registration

Answer 14

• must be licensed and/or registered with their home state
• Register with NY as a non-resident establishment

Question 15

Mail order: communication requirements for patient questions

Answer 15

must provide a toll free number during normal business hours at least 40 hrs/week for communication between patient and pharmacist

Question 16

what is a resident agent in regard to out of state mail order pharmacy?

Answer 16

a required designee for the company in NYS to receive notice of laws

Question 17

Non-resident establishments (mail order, manufacturers, wholesalers) may be exempt from registration requirements if……

Answer 17

Mail order:
- dispense 600 or fewer Rx/year to NY
Manufacturers & wholesalers:
- make < $10,000 in sales to NY per year

Question 18

Requirements for NY based mail order to send Rx to other states?

Answer 18

no specific language, default to receiving state regulations

Question 19

Fees for a pharmacy (building) license?

Answer 19

Application: $345
Renewal: $260
Endorsement (Relocation): $50

Question 20

Requirements for an owner to apply for a pharmacy license:

Answer 20

Good moral character

Corporate applicants
- all
officers/directors/stockholders having 10% or greater interest in the company must also be of good moral character

Question 21

Do you need to be a RPh to own a pharmacy

Answer 21

No, but if the owner is not an RPh, they must have a licensed Supervising Pharmacist on the registration

Question 22

Pharmacist in charge (PIC) aka supervising pharmacist requirements:

Answer 22

full time employee (30 hrs min)
- or majority hours of operation if not open 30 hrs/week

only 1 PIC per pharmacy

Question 23

If drugs are to be sold at auction when must the board be notified?

Answer 23

at least 7 days prior

Question 24

Fee for name change/ renovation/ owner change?

Answer 24

Nah

Question 25

Change of PIC: when must the board be notified

Answer 25

Owner must notify board within 7 days

Question 26

Damage by fire/disaster/flood: when must the board be notified

Answer 26

within 48 hrs

Question 27

Pharmacy signage requirements:

Answer 27

• 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)

Question 28

Preceptor to intern ratio

Answer 28

1 pharmacist may supervise only 1 full time OR 2 part time interns at a time

Question 29

Rx per year : # of interns allowed

Answer 29

Must dispense 5,000 Rx yearly per intern

interns do not contribute to the RPh : Pharm Tech ratio.