Pharmacy Law - Pa Pharmacy Regulations

Front 1

Who inspects retail pharmacies?

Back 1

State Board of Pharmacy

Front 2

Who inspects hospital pharmacies?

Back 2

Department of Health

***Dept of Health can report its findings to the board which can then follow up its own inspection***

Front 3

What is required to obtain a pharmacy permit?

Back 3

3 Names + 1 Address

Name pharmacy, current owner, pharmacy manager
Address of pharmacy

Front 4

When is a new permit required?

Back 4

Changes in Name, Ownership and Controlling Interest
File within 30 days of change

Front 5

What do you need to do in order to close a pharmacy and sell your inventory?

Back 5

You must notify the Board of Disposition of Files/Drugs.
You need permission of the board if more than 30 days have elapsed since closing.
You must return your permit to the board of pharmacy
Signs/Symbols must be removed from interior/exterior.

Front 6

What do you do if your pharmacy loses its pharmacy manager?

***Know this. It will be on the exam***

Back 6

The permit holder must notify the board of loss and new manager within 15 days in writing
Permit holder may request an extension of 30 days to find replacement in writing
Once the board is notified of a new manager, approval is assumed if not notified by Board within 30 days

Front 7

Continuation

Back 7

You can request the board to waive the rule that a pharmacist manager cannot manage more than one pharmacy at any given time.
This must be in writing and is good for 60 days in addition to the 15 days normally allowed to obtain a replacement.
This is done so the nearby pharmacy manager of your other store manages your first store that lost its pharmacy manager.

Front 8

When are separate permits required?

Back 8

In each pharmacy unless a satellite pharmacy.
This refers to satellite pharmacies in a hospital. If the hospital owns a pharmacy a few blocks away, it requires a separate permit.

Front 9

What are the responsibility of pa interns?

Back 9

Accept and Transcribe oral order telephone prescriptions
May neither enter nor be in a pharmacy if a pharmacist is not on duty
May perform procedures which require professional skill and training

Front 10

What are the responsibilities of pharmacy technicians?

Back 10

Cannot accept or transcribe oral orders on telephone
Cannot enter or be in pharmacy without a pharmacist
Cannot perform acts of discretion or professional judgment
May not perform a duty until trained
May assist in reconstituting parenterals etc

Front 11

What are technician protocols?

Back 11

They specify duties tech may perform
Created by pharmacy manager
Pharmacy manager and tech shall date and sign protocols and each amendment.

Front 12

The board stresses this of pharmacy managers

Back 12

For any professional duty like removing drugs and removing controlled substances, professional duty falls upon pharmacy manager

Front 13

Supply requirements

Back 13

Refrigerator in Rx area with temperature monitoring.
Original prescriptions or images retained for 2 years from date of most recent filling
Additional equipment and supplies consistent with scope of practice.

Front 14

What reference materials must you have in the pharmacy?

Back 14

Pharmacy Act
Title 49, Chapter 27 (can go online without a hard copy)
Federal and PA statutes and regulations related to the practice of pharmacy
Adequate reference library

Front 15

Describe an adequate reference library.

Back 15

Enables compounding in a safe and effective manner
Lists drug interactions and possible adverse effects
Lists therapeutic equivalents for medications
Lists usage and dosage of medications
Provides guidelines for counseling

Front 16

New Pharmacy or change in location

Back 16

You dont HAVE to send your plans to the board for prior approval.
You can just make sure you it is properly built and then tell board to inspect you whenever available.

Front 17

In making substantial alterations to your pharmacy, practice shall cease unless

Back 17

Adequate precautions for healthy and safety
Plans for the alterations and precautions are submitted to the board at least 30 days before alterations and no objection is received.

Front 18

What are the building standards in a pharmacy?

Back 18

Prescription area shall be at least 250 square feet

The prescription counter must be at least 10 feet length by 2 feet width. If more than 2 pharmacists are on duty at the same time, increase the length by 5 ft for each additional pharmacist.

Front 19

Describe common dispensing restrictions

Back 19

Cannot dispense CV cough prep containing dilaudid, codeine or cough prep with any other narcotic without rx
Cannot fill/refill where prescriber is deceased or no longer in practice
Rx's/PRN refill Rx's may be refills for 1 year

Front 20

Describe the restrictions on dispensing controlled substances

Back 20

Rx's for CII's may not be refilled
Rx's for CII's may not be filled beyond 6 months from date of issue
Rx's for CIII - Vs may not be filled or refilled more than 5 times in a 6 month period from date of Rx.

Front 21

Pre-packing is labeled with

***Memorize this***

Back 21

Name of drug/name of manufacturer if generic
Strength of drug
Manufacturer's control number
Expiration date

Front 22

Mailing Prescriptions

Back 22

Can only be done by first class or common carrier (fedex or ups) unless patient agrees to slower means
Mailing of reconstituted antibiotics is prohibited
Mailing of drug or device that easily deteriorates IS permitted if proper measures are taken

Front 23

Advertising and Sale of Drugs

Back 23

No advertising to PA patients unless person is licensed or Rx is filled in pharmacy licensed by board
No promotion of CS
No false or misleading advertising
For commercially reasonable quantity
20% off sales etc require showing price list

Front 24

Rx copies

Back 24

Patient has the right to request a Rx copy
Need to show acceptable ID and authorization
Pharmacist records date, who gets and who gives the copy

Front 25

Sales of syringes and needles

Back 25

Don't need a Rx
Must be kept in Rx area
No age limit
No quantity limit
No record keeping requirement

Front 26

Labeling institutional drugs

Back 26

Unit Dose drugs = not required to conform to normal labeling requirements
Non - unit dose drugs = need patients name, drug name, strength, dosing instructions, lot number
Parenteral, enteral, TPN's have all of that and pharmacists initials
***compounding preparations need pharmacist initials***

Front 27

Prospective Drug Review

Back 27

is required for Rx's dispensed at retail locations, hospital inpatient/outpatients and to personal care home residents.

Counseling is required for new retail and outpatient Rx's, NOT inpatients - only a pharmacist may counsel

Front 28

Confidentiality - information about a patient shall be confidential and may be revealed only

Back 28

by patient consent
Board requires the info
State or Federal law requires it
Court order

Front 29

Random Fact

Back 29

A pharmacy may not contribute in any way to the installation of a fax machine in a prescribers office or institution

Front 30

Pharmacy Permit renewals
Pharmacy License renewals

Back 30

Every 2 years (odd)
Every 2 years (even)

Front 31

Return to Stock of Undelivered Medications

Back 31

If no lot # or expiration dates, then its ok to dispense for only 6 months from date of original dispensing.
If recall, assume it is from the recalled lot #

Front 32

For Electronic Rx's

Back 32

You must retain a hard copy or readily retrievable image of transmitted Rx information for 2 years from date of most recent filling

Front 33

Computerized record keeping systems

Back 33

Eliminate the need to retain hard copies
Records for Rx's filled within last 12 months must be immediately retrievable
Within the last 24 months must be retrievable within 3 working days
ID of pharmacist responsible for Rx info entered into computer system

Front 34

Central Fill Pharmacies

Back 34

Must have a contract or same owner as the originating and delivering pharmacy
Maintain confidentiality
Show audit trail
Must share common electronic file

Front 35

Centralized pharmacies

Back 35

Not required to maintain $5000 worth of nonproprietary drugs and devices
Not required to conform to minimum space requirements (250 square ft)
No required to have a sink of restroom facilities

Front 36

The pharmacy act was recently updated to allow for Drug Therapy Management

Back 36

Adjusting drug regimen, drug strength, frequency of administration, route, D/C, administration, lab tests, diagnostic tests.
This was originally based on institutional status of patient. Updated to allow outside institutions.

Front 37

Qualifications to administer biologicals, medications and immunizations

Back 37

Need an active PA license to practice Pharmacy
Certification of having completed a course
CPR cert
Separate application to the board is required
"A pharmacist who is granted authority may administer injectable medications biologicals and immunizations to person who are MORE THAN 18 YEARS OF AGE
Must only do so under an ORDER or WRITTEN PROTOCOL

Front 38

Multiple Licensure Reporting

Back 38

Licensed pharmacist in PA who is also licensed to practice pharmacy in any other state, territory or country shall report this information to the board on the biennial registration application.
Any disciplinary action taken by another state, shall also be reported to the board on the biennial registration application or within 90 days of final disposition, whichever is sooner.