Pharmacy

Question 1

Permit Application

Answer 1

EXACT location and plan or physical arrangement and where drugs would be stored/dispensed
- Exact trade names/corporate names/ name and addresses of owner and operators/
-fee
- PIC in good standing in NJ
- all entity or equity holder shall be of high moral character
- may be interviewed by board
- board inspection

Question 2

Permit approval

Answer 2

Permit number issued to place drugs on premises
(but not sell, dispense, or open for business)

Question 3

Pharmacy Opening

Answer 3

within 90 days of approval - notify board pharmacy is open for business
if more time needed beyond 90 days but less than 30 days –> submit written request for extension
–> license rescind if pharmacy not open in 90 days and no extension requested.

Question 4

Pharmacy Permits

Answer 4

renewal annual basis & displayed in view of the public

Question 5

Renewal process

Answer 5

within 30 days of expiration -
Application + renewal fee

Question 6

Death of owner or partner or partnership terminated

Answer 6

Permit shall be returned to board and reapply for permit

Question 7

Change in Ownership

Answer 7

within 30 days new owners submit permit application for change in ownership + fee + document of change in ownership
- New owners shall perform controlled inventory
- New permit # if requested at time of filing

Question 8

Change of registered agents or officers

Answer 8

within 30 days - submit affidavit indicating change

Question 9

Change in stock ownership 10% or more

Answer 9

within 30 days - submit affidavit indicating change

Question 10

reallocation of ownership among existing owners

Answer 10

within 30 days - submit affidavit explaining

Question 11

Changes

Answer 11

New owners shall take custodial ownership of previous 5 yrs of prescription and patient records

Question 12

Change of NAME

Answer 12

30 days PRIOR to change apply for amended permit
application + fee and return old permit
if in ownership then reapply over

Question 13

Change of location

Answer 13

30 days PRIOR - apply for NEW permit
- if temp closing - post signs and notify board if >48 hrs
NEW application + FEE + Board inspection and approve all fixtures, equipment, premises and inventory ====> amended permit

Question 14

Change in address but not physical location

Answer 14

notify board within 10 days
Submit affidavit to Board

Question 15

Remodeling Premises

Answer 15

Change within premises of location and or size of prescription area or change in licesed premises —> notify board within 30 days in advance
-submit plans for operations during remodeling and anticipated date of completion
board review and approve

Question 16

Remodel Premises

Answer 16

Notify board upon completion of remodel and within 60 days of completion board shall inspect and approve

Question 17

Closed pharmacies

Answer 17

IMMEDIATELY send written notification of anticipated closing to Board and DEA at least 15 days prior to closing date

IF death - ASAP to actual closing date to board and DEA

All Medications be transferred to holder of a current pharmacy permit, wholesaler, reverse distributer or mfg
or properly disposed prescribed by board and DEA

Question 18

Closing pharmacy procedures

Answer 18

1. within 30 days - remove all drug signs from inside and outside and notify board location of 5 yrs of prescription storage
2. return permit within 30 days of closing
3. access to rx and profile records within 24 hours of the transfer and all calls forward to new pharmacy

Question 19

Pharmacy Records Termination of change in ownership

Answer 19

notify patrons have right to obtain their records at which location anad pt profile for one year
1. notification to board
2. publication once weekly for two weeks in newspaer in geographic location pharmacy is located - right to obtain rx and profile and location
3. sign placed in pharmacy location of this notification
4. and on social media platform if pharmacy used social media

Question 20

Business hours

Answer 20

40 hours/week and 5 days a week at least

Question 21

Change in business hours

Answer 21

permanent changes - notify within 30 days
Notice be displayed on exterior of any temporary changes

Question 22

Discontinued pharmacy

Answer 22

if pharmacy closed >48 hours without notifying board
If closing >48 hours - notify board for approval with contingency plans for accessing patient records

Question 23

Security and responsibility

Answer 23

RPH on duty to keep pharmacy or department closed and security system turned on at all times when not present.
- security of rx dispensing area and contents are maintained at all times, restriction of unauthorized persons
-reporting theft to PIC or permit holder

Question 24

Theft

Answer 24

• quantity missing
• drug
  -loss is by specific individuals or unique activites that may take place
• pattern of losses over specific time period or random and efforts to resolve the losses
• if known are likely candidates for theft or diversion
• local trends or other indications for theft

Question 25

Holder of permit and PIC shall

Answer 25

1. all entrances to department are capable of being locked and connected to monitored security system (audible, visual or electronic) w/back up mechanism
2. file written report w/board of theft/loss/diversion and dea
3. secure are for receiving packages during business hours only
4. if drop off device utlized for prescriptions then it must be a one-way, irretrievable and secure design
   5.

Question 26

Centralized pharmacy

Answer 26

= 2 more pharmacies sharing responsibility for handling rx
- have contractual agreement or have same owner
- obtain board approval
- have audit trail all steps performed by whom
-have label
-

Question 27

Requirements

Answer 27

1) At least 150 square feet for the prescription area with a prescription counter that is at least 18 inches in width and at least 12 feet in length.
2) A sink with hot and cold running water easily accessible to the prescription counter.
3) Adequate storage space (shelves, drawers, cabinets) for prescription drugs and chemicals, including a securely locked storage place for Schedule II controlled substances.
4) The most recent edition of comprehensive pharmaceutical reference texts (can be unabridged electronic versions). See specific categories listed on the Board’s website
5) An over-the-counter Schedule V Record Book or electronic recording system.
6) A permanent prescription filing device and patient profile record system.
7) A steel and rubber spatula, counting trays or approved counting devices, labels, auxiliary labels, assorted prescription containers, and child safety closures or caps.
8) A refrigerator, per USP standards, used only for the storage of pharmaceuticals and refrigerator and freezer thermometer.

Question 28

Non sterile pharmacy requirements

Answer 28

1. ) A Class A prescription balance with metric weights or an equivalent electronic weighing device.
   2) A glass mortar and pestle, glass funnels, and stirring rods.
   3) An ointment tile or parchment paper.

Question 29

Signages

Answer 29

Pharmacies must post a sign on the exterior of the building or a sign which is otherwise visible from a public roadway, identifying the existence of a pharmacy.

Pharmacies must post the hours that the pharmacy is open and the name of the pharmacist-in-charge in plain view of the public at all consumer entrances and consumer access points to the pharmacy, including drive-thru windows and drop-off boxes.

In the case of a pharmacy department, when the premises in which the pharmacy department is located maintains different hours of operation from the pharmacy department, all signs, advertising, etc., must clearly and distinctly indicate the hours that the pharmacy department is open.

A sign at the entrance and where prescription drugs or biological products are sold disclosing the fact that upon request, before a prescription is dispensed, a consumer shall be told the price of the product, whether it is to be substituted from a list of interchangeable drugs, and of the consumer’s right to be informed of the price savings resulting from substitution, and the right to refuse the substitution if not satisfied with said price savings. Such a sign shall not be less than 12 inches by 12 inches.

When the pharmacist is on break, a sign shall be posted in the prescription dispensing area stating “Pharmacist on break, but available for emergencies and counseling.”

Question 30

Advertising

Answer 30

Price quotations for prescription drugs appearing in any advertisement shall state the strength and quantity required to be purchased for the offered cost, shall include the usual and customary prescription cost and the effective period of the price quotation. All services including, but not limited to, delivery charges rendered by the pharmacy which will add additional costs to the price quoted must be set forth in the advertisement.

Any reference in any form to the quality of a drug or its beneficial use is prohibited.

All advertisements shall be predominantly informational and shall not be misleading, confusing, or false. Any advertisement demeaning the quality of professional services rendered by another licensee or permittee shall be prohibited.

No person shall carry on, conduct or transact business under a name which contains as a part thereof the words “pharmacist,” “pharmacy,” “apothecary,” “apothecary shop,” “druggist,” “ drug” or any word or words of similar or like import, unless the place of business is a currently licensed pharmacy practice site operated or managed at all times by a pharmacist.