PA LAW- Chapter 3

PA law gives who prescriptive authority?

• practitioners with independent authority

• physician assistants

• certified registered nurse practitioners

• nurse midwives

Do pharmacists have prescriptive authority in PA?

no

Practitioners with independent authority include MD, DO, Dentists, podiatrists, optometrists and vets. What can a MD and DO do that the other practitioners can’t?

• DO or MD may legally prescribe a drug to treat ANY disease/illness EVEN OUTSIDE THEIR SPECIALITY

• Dentists, vets, podiatrists may ONLY prescribe within their practice

• optometrists also have limited formulary

What must physician assistants have in order to prescribe medications?

What are the CII limits for physician assistants?

(burns said focus on CS)

• physician MUST delegate authority to prescribe (written agreement, includes what can/can’t prescribe)

• CII—> limited to 72 hrs dose for initial therapy and a 30 day supply for ongoing therapy

  • (MUST PUT ON THERE IF IT’S FOR INITIAL OR ONGOING THERAPY)

What must certified registered nurse practitioners have in order to prescribe medications?

• must have rx authority from the board of nursing + enter collaborative agreement with a physician

What are the CS limits for Certified Nurse Practitioners?

• CII limited to ____ day supply

• CIII or CIV limited to ____ day supply

• may NOT prescribe CS where?

• are oral emergency CII rx allowed? written rx in ___ hours?

(burns said focus on CS)

• CII limited to 30 day supply

• CIII or CIV limited to 90 day supply

• may NOT prescribe CS in a pain clinic

• may prescribe ORAL emergency CII prescription—> must deliver written rx within 72 HOURS

What are the CS limits for Nuse Midwives?

• may ONLY prescribe for?

• CII limited to ____ supply

• CIII and CIV limited to ______ supply

(burns said focus on CS)

• may ONLY prescribe for WOMEN’s ACUTE PAIN

• CII limited to 72 hour supply and can only be extended with physician approval

• CIII and CIV limited to 30 day supply (and can only be refilled with physician approval)

Optometrists have what kind of prescriptive authority?

In order to have CS what must be obtained?

What CS can be prescribed? Any time limits?

• optometrists have “limited formulary”

• must get DEA # to administer/prescribe CS

• CS limited to:

  • codeine combo products (APAP or aspirin)

  • hydrocodone combo products (APAP or ibuprofen)

  • pentazocrine

  • tramadol

• HYDROCODONE COMBINATION PRODUCTS ARE LIMITED TO 72 HOUR SUPPLY (COMBO NOT ALONE—> cannot prescribe JUST HYDROCODONE)

What does PA say about self-prescribing for family members?

generally not recommended (no law or legal authority saying you can’t though)

What does PA say about retired/deceased practitioners?

PBOP—> NO rx may be knowingly filled if written by a prescriber who is deceased or no longer in practice (IN THE LAW)

What does PA say about off-label use?

• no law that prohibits this

• pharmacist uses professional judgement

What does PA say about office-use prescriptions?

• NO NO NO—> cannot fill an rx “for office use”

• prescription must be for a pt.!!

The Pennsylvania Board of Pharmacy (PBOP) consists of how many members? What is the breakdown of those members? How many are pharmacists?

9 MEMBERS TOTAL

• 5 members= licensed pharmacists (for at least 5yrs)

• 2 members= consumer/public members

• 2 members= 1 is commissioner of professional and occupational affairs, 1 is direct of the bureau of consumer protection in the office of the AG

Of the 5 licensed pharmacists on the PBOB, what kind of pharmacists are they?

(retail, hospital, etc.)

• 2 pharmacists= independent retail pharmacists

• 2 pharmacists= employed by retail chain (chain means 5+ pharmacies)

• 1 pharmacist= acute care institutional pharmacy

In addition to the 9 members on the PBOP, who else is involved?

• “EXECUTIVE DIRECTOR” (NOT PART OF THE 9 MEMBERS)

• MUST be a Pharmacist

• IS AN EMPLOYEE NOT A BOARD MEMBER!!!!!!!!!!

Term limits for the PBOP members? (idk how imp)

• 6 yr terms

• cannot serve more than 2+ terms

Definition of dispense/dispensing: (idk how imp)

Preparation of a prescription/nonprescription drug in a suitable container appropriately labeled for subsequent admin to or use by a pt. or other individual entitled to receive the drug

Definition of non-proprietary drug and proprietary drug: (idk how imp)

Non-proprietary drug	A drug containing any quantity of any controlled substance or any drug required by any applicable federal or state law to be dispensed only by rx
Proprietary drug	Nonprescription, non-narcotic medicines or drugs which may be sold without a rx and are prepackaged for consumer use and labeled in accordance with state and federal laws

Definition of prescription: (idk how imp)

Written/oral order issued by a licensed medical practitioner in the course of their practice for a CS, other drug or device, or medication which is dispensed for use by consumer

Definition of emergency prescription:

When must the prescriber be notified?

Refill of a rx that is essential to continuation of therapy in a chronic condition, for which the refill has not been authorized and for which the pharmacist notifies the prescriber within 72 HOURS that an emergency rx has been dispensed

Definition of drug admin: (idk how imp)

Direct introduction of or application of a drug into or on the body of a patient by injection, inhalation, ingestion or any other means and, where required by law, shall occur only pursuant to a med order

Definition of protocol:

Written doc that describes nature/scope of drug therapy management to be carried out by pharmacist

What does the practice of pharmacy NOT include?

operation of a manufacturer or distributor (PCSDDCA)

In the practice of pharmacy, management of drug therapy is permitted under a…

written collaborative agreement (pharmacy act)

Obtaining an initial pharmacist license involves completing an online application and paying fees. How long is the application valid before it needs updated? After how long is it no longer valid at all?

• application valid for 6 months then must be updated

• after 1 year—> new application and fee required

Requirements for initial PA pharmacy license:

• what age?

• receive a degree from where?

• Can I have felonies related to CS?

• Must pass what exams?

• must be at least 21 yrs old

• receive degree from ACPE-accredited school/college

• cannot have felonies related to CS unless 10 yrs have lapsed and proven to PBOP not a risk to the public

• MUST PASS NAPLEX AND MPJE

For PA initial licensure, how many hours of internship must be completed? Can I complete these hours through pharmacy rotations or do they have to be done externally?

• SERVE AT LEAST 1,500 hours

  • ALL hours can be earned through pharm rotations (new(er) board waiver)

For INITIAL PA Pharmacist license, what training MUST be completed? What training is waived?

• MUST DO

  • 3 HRS of mandated reporter training

  • 4 HRS of opioid practices:

    • 2 hours of pain management

    • 2 hours on opioid training/education

• Waived—> 30 hours of continuing education

Licensure by reciprocity (Aka—> I’m registered in Ohio, but now I wanna be in PA), has what as an alternative to 1,500 hours of internship?

show proof as pharmacist in another state for 1 year

For licensure by reciprocity, what trainings must be completed?

• SAME AS INITIAL LICENSUREEE

  • 3 HRS of mandated reporter training

  • 4 HRS of opioid practices:

    • 2 hours of pain management

    • 2 hours on opioid training/education

For license by reciprocity, you normally must pass the PA MPJE.

What are the exceptions?

Initial pharmacist license after 1983 and passed the FDLE for license being transferred

Pharmacists MUST renew their license how often? What date does it expire?

biennially or every 2 years

• expires on 9/30 of even-number years (T-pain’s birthday)

Any disciplinary action taken by another state must be reported within ____ days of final outcome or on renewal application.

30

FOR A LICENSED PHARMACIST, how many hours of continuing education must be completed before their renewal?

30 hours of CE

FOR RECIPROCITY INITIAL LICENSES, how many hours of CE must be completed before their 1st renewal?

(note this is the 1st renewal… like a Pharmacist that was from ohio, but now in PA… this is how many CE hours they need before 9/30 of their 1st time renewing their license)

• prorated based on how long licensed in PA before renewal

  • prorated to 3.75 for each full quarter (3m) during initial licensure

  • (ex: say a pharmacist was only licensed in PA for 6 months before it’s time to renew—> they would have to do 7.5 hours of CE)

Of the 30 hours of CE requirements that a pharmacist must complete before renewal, how many of those hours must be on specific topics? what ARE those topics?

• of the 30 hours:

  • 2 hours MUST be in patient safety

  • 2 hours must be in opioid practices (initial was 4)

  • 2 hours must be in child abuse programs (inital was 3)

  • IF LICENSED TO INJECT—> 2 hours must be in immunization topics

• these ALL COUNT TOWARDS the 30 hours

How do you know what ACPE courses are in the “patient safety” topic?

topic designator is 05 (so it will be 05-P)

You are a pharmacist that just got their license in February 2026. Renewal is September 2026. Do you have to do 30 hours of CE for renewal in September?

no, but must do 2 hours of mandated reporter training, and 2 hours of opioid practices

If your pharmacist license is suspended or revoked, should you still do your CE hours?

yes—> if you want to resume practicing eventually

License for authorization to administer injectables, biologicals, and immunizations is voluntary or mandatory?

additional voluntary license

What are the requirements for license to immunize?

• must have active ________________

• must complete ________________

  • how long is this valid?

• must be _________ certified

• must carry professional ______________, a minimum of ________________

• must have active license (pharmacist or intern)

• must complete education/training

  • training program is only valid for 3 years from date of completion

• must be CPR certified

• must carry professional liability insurance, a minimum of 1 million dollars per occurance/clain

Pharmacists MUST renew their license for authorization to inject every ____ years.

2 (and complete 2 hours of immunization related CE)

Pharmacy Interns MUST renew their license for authorization to inject every _____ years.

trick question—> do not have to renew

What are the conditions/authority for immunizations?

• allowed to give injectables to ≥___ years of age or older

• COVID and flu shots ≥____ years of age or older

• If under 18 need what?

• What about technicians? ≥_____ years of age or older

• allowed to give injectables to ≥ 8 years of age or older (for any CDC recommended vaccine)

• COVID and flu shots ≥5 years of age or older

• If under 18 need what? parental consent

• What about technicians? ≥13 years of age or older

How long are immunization records kept for?

2 years

What are the only 2 ways pharmacists, interns, techs are allowed to immunize?

How long is a protocol good for?

1. a prescription

2. written protocol (btwn pharmacies and physicians/institutions)—> good for 2 years

In regards to notifying after giving a vaccine…

• administering under an ORDER requires notification of who? within what time frame?

  • Or who if known rx?

• If there is an adverse drug reaction, notification is within what time frame?

• DOH must be notified within what time frame?

• Administering under an order requires to notify PCP and primary care doctor if known within 48 hours

  • Or prescriber and primary if known if rx

• If ADRs—> notify within 24 hours

• Notify DOH within 72 hours

Answer the following about INTERN REGISTRATION:

• available for who?

• must be supervised?

• license is valid for how many years?

• 1,500 hours are required, how many max a week?

• must do what training?

• available for people who have completed 2 years of college and enrolled in pharm school

• must be under direct supervision of pharmacist

• valid for 6 years from date of issuance

• max 50 hours a week

• must complete 3 hours of mandated reporter training

Preceptors can have max ___ students (n/a to schools).

2

What are the CURRENT registration requirements for pharmacy technicians?

• NO registration required CURRENTLY

• HOWEVER… new laws about to pass that require registration!!!

PA Act amended the PPA and will make what new requirements for pharmacy technicians?

• requires registration? yes or no

• will create what 2 new categories?

• age requirements?

• renewal?

new laws (NOT IN EFFECT YET) will require:

• yes registration

• will create 2 new categories: pharmacy technician and pharmacy technician trainee

• must be 16 yrs old to become pharm tech trainee

• must be 17 yrs old with high school diploma to be pharm tech

• trainee will expire after 2 years

• registration every biennially in odd years

What must be displayed at all times in a conspicuous place in the pharmacy?

all licenses, registration, and permits issued

Prior to advertising or engaging in the operation of a pharmacy—> a person or business must file an application to receive what from the PBOP?

permit

What are the application requirements for a pharmacy permit? permit requirements in general?

• name, license of who’s in charge

• owner’s name, and information on anyone that holds more than a 10% interest

• detailed floor plan and info for the prescription area

• permit requirements: name and address of pharmacy, name of current owner, name of current pharmacist manager

After permit application is submitted, what happens and who gives out the pharmacy permit is passed?

inspector comes and gives out permit if passed

Each pharmacy in PA requires a separate permit AND separate what? exceptions?

and SEPERATE MANAGER!!!!!!!—> 1 MANAGER PER PHARMACY!!!!

• 2 exceptions to manager rule: satellite pharmacies and 60 day temp waiver if manager leaves and can’t find another manager (details in another card)

Any change in name of pharmacy or ownership requires…

a. board approval

b. application

c. new permit

c

If a pharmacy closes down…

• what happens to permit?

• location of what must be provided?

• what happens after 30 days?

• return permit

• provide location of files

• after 30 days—> rx files or non-proprietary drugs are not allowed to be sold, transferred, or disposed of… unless granted permission

In the event there is a change in pharmacy manager, WHO’s RESPONSIBILITY is it to notify the PBOP? Within how many days?

• PERMIT HOLDER/PHARMACY OWNER’S RESPONSIBILITY TO inform board within 15 DAYS

  • (note this… bc in a lot of states it’s the manager’s resp.)

If for some reason a pharmacy manager leaves/quits, what are the 2 pathways if an owner cannot find a new manager? What are their time limits?

• IN ADDITION TO THE 15 DAY EXTENSION!!!!!!!!!!

  • 1. can get a 30 day extension (on top of 15)

  • 2. can have another pharmacy manager serve as a manager at 2 places for up to 60 days (on top of 15)

The prescription area can ONLY be open when there is a licensed pharmacist on duty. What is the 1 exception to this? requirements?

30 MINUTE BREAK!!!

• pharmacist allowed 30 min break

• pharmacist MUST remain in immediate building

• pharmacist MUST be available for emergencies or counseling

• employees are allowed to do any normal service BUT counsel and final check (pharmacist only functions)

Pharmacies must main an inventory of at least $__________ worth of ____________ drugs/device.

$5,000 worth of nonproprietary drugs/devices

What are some things pharmacies must contain?

• ex: drug only fridge

• (FYI: not applicable to central fill)

• lowkey common sense

• fridge only for drugs

• prescription files

• copies of PA pharmacy act and PBOP rules

• any equipment for preparing/dispensing

• ADEQUATE REFERENCE LIBRARY!!!!

If I wanted to construct a new pharmacy or change locations does it have to be approved first? submission time requirements?

• yes new pharmacies/change of location must be approved first

• WITHIN 90 DAYS of submission PBOP will approve/deny

If I had a pre-existing pharmacy, but wanted to undergo CONSTRUCTION that is SUBSTANTIAL. What 2 things can happen? submission time requirements?

• stop practice of pharmacy

• UNLESS

• pharmacy submits alterations and a safety plan to the PBOP 30 DAYS PRIOR

(think: new pharm/change of loc is 90 days, substantial construction is 30 days)

What must the dimensions of each of the following be:

• prescription area

• working counter

  • if more than 2 pharm?

• not applicable to…

• rx area: minimum 250 sq ft

• working counter: 10ft long x 2 ft wide

  • if more than 2 pharmacists—> minimum length increased by 5 ft

• not applicable to central fill

Some retail pharmacies are in retail establishments with business hours different from the pharmacy (ex: Walmart).

What are the additional requirements for these pharmacies?

• barrier?

• where must hours be posted?

• protocols?

• must have barrier to seal pharmacy off floor to ceiling

• hours of pharmacy are posted at all point of public access

• protocols in place for when non-pharmacist staff needs access in emergencies

  • ex: fire

Are PA law and federal law different in terms of STORAGE for CS? How?

PA law and federal law the same for storage requirements for CS!!!!

What are the storage requirements for CS in PA?

• where are CI—> CV?

• rx area of pharmacy must have cabinet or safe for CS unless CS are dispersed throughout!!!

  • exception: C1’s must be locked up always

• example: CII’s can either be locked up or dispersed throughout

Answer the following about random pharmacy requirements:

• sink?

• restrooms?

• TV’s?

• must have sink in rx area—> with hot and cold water

  • only used for pharmacy purposes

• restrooms close to pharmacy, but outside rx area

• NO TV’S allowed in rx area or that can be seen from rx area

How are the permits for institutional pharmacies compared to other pharmacy permits like community?

NO special/different permits, however additional requirements must be met.

What are the additional requirements for institutional pharmacy PERMITS?

• institution must be…

• hours open?

• must always meet who’s rules and regulations?

• institution must be accredited, licensed, and meet standards

• pharmacy inside MUST be open a minimum of 20 hours PER WEEK

• must always meet PA department of health and department of welfare rules/regulations

What VOLUNTARY program allowed unused cancer drugs to be re-dispensed to cancer pts.?

cancer drug repository program

Requirements for Cancer Drug Repository Program:

• must have what documents?

• once approved, pharmacist can accept drugs from who?

• what drugs can be donated?

• what drugs can’t be donated?

  • expiration?

• must have pharmacy permit to apply

• once approved—> pharmacist can accept eligible donated cancer drugs from other pharmacies, facility, manufacturers, distributors, etc.

  • NOT FROM A PATIENT!!!!!!!!!!!

• what drugs can be donated?

  • original unopened, sealed

• what drugs can’t be donated?

  • if expiration date earlier than 6m from date drug will be restocked by pharmacy

  • compounded drugs, CS, any drug requiring refrigeration

Requirements for Cancer Drug Repository Program:

• what must the pt. receiving the donated drug do?

• allowed to charge what?

• can only be dispensed to who?

• pt. receiving donated drug MUST sign waiver consenting they know the drug dispensed is part of this program

  • keep waiver for 2yr

• allowed to charge a state-set handling fee for dispensing a covered product

• can only be dispensed to eligible pts. (ex: they aren’t covered, income limits)

In PA, do non-resident pharmacies have to register? requirements for registration?

YES!!!!—> any pharmacy that ships, mails, delivers, or anything must get non-resident registration

In order for non-resident pharmacy to get registration what are the requirements?

• renewal period?

• what happens if any disciplinary action?

• hours open?

• phone?

• renewed biennial

• if disciplinary action—> report to PBOP within 30 days

• MUST BE OPEN at least 6 days a week, minimum 40 hours a week

• must have phone #