Practice of Pharmacy

What does the “practice of pharmacy” generally include?

Activities legally within a pharmacist’s scope, such as evaluating prescriptions, dispensing, compounding, counseling, DUR, advising patients or prescribers, administering medications or vaccines, prescribing when authorized, maintaining records, storing medications, and ordering or interpreting labs when permitted.

Who may perform activities that fall within the practice of pharmacy?

Generally, a licensed pharmacist. Exceptions may include:

• another healthcare professional whose practice act authorizes the same activity

• a pharmacy intern authorized by state law and working under pharmacist supervision

The activity must not be prohibited by state or federal law.

What are the main pathways and common requirements for pharmacist licensure?

Common pathways are:

• licensure by examination

• reciprocity/endorsement

• foreign graduate pathways

States may require exams such as NAPLEX and a law exam, experience hours, minimum age, criminal history checks, and limits on exam attempts or waiting periods between attempts.

What are the key rules for reciprocity and reactivation of an inactive pharmacist license?

Reciprocity may require an original exam-based license that is active and in good standing. Some states accept a reciprocity license as the basis for another reciprocity application, while others do not.

A pharmacist who has been inactive or out of practice for years may be required to complete exams, APPE hours, or CE before returning to good standing.

Do pharmacists generally have broad authority to diagnose and prescribe?

No.

• Broad diagnostic authority is uncommon.

• Pharmacists generally do not have unrestricted authority to prescribe all medications.

• Prescribing authority usually comes through specific state-authorized mechanisms, such as CPAs, statewide protocols, or category-specific authority.

What are common requirements for maintaining a pharmacist license?

States commonly require:

• license renewal every 1–2 years

• renewal forms and fees

• continuing education

CE requirements vary and may include live hours or required topics such as law, vaccines, opioids, or medication safety. Some states allow excess CE to carry over; others do not.

How is pharmacist immunization authority determined?

: State law determines whether pharmacists, interns, and sometimes technicians may administer vaccines.

States may limit:

• which vaccines can be given

• eligible patient age groups

• whether authority comes from a protocol, standing order, or patient-specific prescription

Training and ongoing CE may also be required.

What must generally be given to a patient receiving a covered vaccine?

The appropriate Vaccine Information Statement, or VIS

What OSHA requirements are especially important for pharmacies providing vaccinations?

Two major areas:

Hazard Communication

• identify and classify chemical hazards

• communicate protective measures

• maintain labels and Safety Data Sheets

• train employees

Bloodborne Pathogens

• PPE

• sharps containers

• employee training

• Hepatitis B vaccination for covered employees

• written Exposure Control Plan

• Universal Precautions

What is an Exposure Control Plan, and what are Universal Precautions?

An Exposure Control Plan is a written plan designed to eliminate or minimize employee exposure to bloodborne pathogens.

Universal Precautions means treating all human blood and certain body fluids as potentially infectious for HIV, HBV, and other bloodborne pathogens.

What reporting or documentation may be required after a pharmacist administers a vaccine?

Depending on state law, the pharmacist may need to:

• notify the patient’s PCP

• report the administration to the state immunization registry or Immunization Information System

Adverse reactions may also need to be reported to:

• the PCP

• the state registry

• a supervising physician under a protocol

• VAERS or MedWatch, when applicable

What are the 3 main ways pharmacists may receive limited prescribing authority?

1. Collaborative Practice Agreement, or CPA

2. Statewide protocol or standing order

3. Direct category-specific authority granted by state law

What is a Collaborative Practice Agreement, or CPA?

A written agreement with a physician or other authorized practitioner that may allow a pharmacist to:

• manage drug therapy

• prescribe specified medications

• order or interpret laboratory tests

It is generally dependent prescriptive authority and is subject to state law and the terms of the agreement.

What additional requirements may apply to pharmacists practicing under a CPA?

Depending on state law, pharmacists may need:

• minimum experience

• residency training

• board certification

• an additional license or designation

• periodic meetings with the supervising practitioner

• renewal of the agreement at state-defined intervals

If controlled substance prescribing is authorized, DEA registration may also be required.

Can a CPA be population-based?

Yes. Some states allow population-based collaborative arrangements, such as for immunizations, where patients do not need individual referral to the pharmacist by a physician.

What is a statewide protocol or standing order?

State-authorized authority allowing pharmacists to prescribe, administer, or dispense certain medications or services, often for population-based public health needs.

Examples may include:

• naloxone

• immunizations

• oral contraceptives

• smoking cessation therapy

• HIV prophylaxis

• TB prophylaxis

It may be established by a Board of Pharmacy, Board of Medicine, or state health authority, depending on state law.

What is direct or unrestricted category-specific pharmacist authority?

State law directly gives pharmacists authority to prescribe, dispense, or administer a specific drug or drug class.

• CPA: authority depends on an agreement with another practitioner

• Statewide protocol: authority comes through a state-level protocol or standing order

• Category-specific authority: state law directly grants authority for a specific drug or class

What does a pharmacy need to perform CLIA-waived testing, and what is test-to-treat?

A pharmacy may obtain a CLIA Certificate of Waiver, issued by CMS, to perform waived tests.

State law determines which tests the pharmacy or pharmacist may perform.

Test-to-treat means the pharmacist performs an authorized test and, when state law permits, provides or prescribes treatment based on the result.

What non-vaccine medications may pharmacists be authorized by state law to administer?

States may authorize pharmacists to administer IV, IM, and subcutaneous medications, often long-acting agents.

These usually require a patient-specific prescription.

What requirements may apply when pharmacists administer medications other than vaccines?

Requirements are often similar to immunization requirements, including:

• patient-specific prescription

• reporting adverse drug reactions to the prescriber

• compliance with any applicable REMS monitoring requirements

Why is it important to distinguish between a prescription, medication order, chart order, and prescription drug order?

States use different terminology, and the applicable definition may depend on whether the setting is:

• outpatient

• inpatient

• or both

The definition affects prescription requirements, recordkeeping, and other laws.

Why are Long-Term Care Facilities, or LTCFs, legally tricky when determining prescription requirements?

LTCFs may combine features of inpatient and outpatient care, so you must determine which state-law definition applies.

Some states allow LTCFs to use medication orders or chart orders for non-controlled substances.

Who determines whether a healthcare professional may prescribe and what limitations apply?

The state licenses healthcare professionals and determines:

• who may prescribe

• what they may prescribe

• whether prescribing is independent or requires physician supervision or collaboration

What types of practitioners may have state-imposed prescribing limitations or supervisory requirements?

Advanced practice providers may be subject to limits or supervision requirements, including:

• nurse practitioners

• physician assistants

• pharmacists with prescribing authority

• certified registered nurse anesthetists

• certified nurse midwives

They may practice under a collaborative agreement or protocol with a supervising physician.

What makes a prescription legally valid?

A valid prescription must:

• be for a legitimate medical purpose

• be issued by a legitimate, properly licensed practitioner

• be issued in the usual course of professional practice

• contain all required elements

• use a legally permitted format, such as written, phone, fax, or electronic

• comply with expiration, refill, and quantity limits

What does “legitimate medical purpose” mean?

The medication is being used for an appropriate disease state or medical condition of the patient.

What does “usual course of professional practice” generally require?

The standard of care must be followed, including:

• an appropriate patient-prescriber interaction

• enough evaluation to establish a proper diagnosis

• treatment within the practitioner’s professional scope of practice

An in-person exam may be needed for some conditions, while telemedicine may be acceptable when equivalent standards are met.

Can telemedicine satisfy the usual-course-of-practice requirement?

Yes, when the technology and encounter allow the prescriber to meet the same appropriate diagnostic and professional standards.

Telemedicine may also be used for follow-up after a patient has been diagnosed.

How does professional scope affect whether a prescription is valid?

The disease state, medication, and patient must generally fall within the prescriber’s professional scope.

Examples:

• dentist → mouth and teeth

• podiatrist → feet

• veterinarian → animals

• optometrist → eyes

A prescription outside a practitioner's legitimate scope may be invalid or require investigation.

Can prescribers legally prescribe medications for off-label uses?

Yes. A practitioner may prescribe a medication for a condition or use that does not appear in the FDA-approved labeling, as long as the prescription is otherwise valid and within professional practice.

What special limitations may apply even when a practitioner is otherwise authorized to prescribe?

Examples include:

• REMS programs requiring special registration or certification

• special limitations on methadone for opioid use disorder

• scope concerns involving highly specialized practices

What sources of law may control prescription requirements?

Multiple laws may apply simultaneously, including:

• federal Controlled Substances Act

• state controlled substance laws

• federal FDCA

• state pharmacy practice acts

• Board of Pharmacy regulations

• other healthcare profession practice acts and board rules

The pharmacy must comply with all applicable laws.

What types of restrictions may apply to controlled or non-controlled prescriptions?

Depending on the law, prescriptions may be subject to:

• expiration dates

• refill limits

• quantity limits

• required transmission format

• written prescription security requirements

Some states also limit opioid quantities for acute pain.

Are preprinted prescription forms allowed for controlled substances?

According to this section, preprinted prescription forms are not allowed for controlled substances.

Written prescriptions may also be subject to security-feature requirements, including requirements related to Medicaid or controlled substances.

What prescription record-retention numbers should I know?

Federal controlled substance prescription records: 2 years

Medicare Part D prescription records: 10 years

States may impose additional or longer requirements for Medicaid prescriptions or prescription records generally.

Can a pharmacy destroy the original paper prescription after making an electronic image?

It depends on state law. Some states allow pharmacies to capture an electronic image and then discard the original hard copy.

Can a pharmacy automatically fill a prescription written by an out-of-state prescriber?

Not automatically.

State law determines whether the prescription may be dispensed. Some states may require:

• compliance with that state's prescription requirements

• the prescriber to be legally authorized to prescribe under applicable state law

What should a pharmacist do when prescription forgery or alteration is suspected?

Investigate the concern before dispensing.

Important points:

• even electronic prescriptions may be forged

• the pharmacist may verify the prescriber through the appropriate state licensing or regulatory website

What are common red flags for prescription misuse, abuse, or diversion?

Examples include:

• multiple prescribers

• multiple pharmacies

• repeated use of emergency departments, urgent care, or walk-in clinics

• early refill requests

• combinations of commonly abused drugs

• traveling in groups to the pharmacy

• patient or prescriber far outside the pharmacy's usual geographic area

• different people dropping off and picking up prescriptions

• paying cash when unusual

• prescriber writing outside scope of practice

• patient dishonesty

• slang names for medications

• patient appearing intoxicated

A red flag requires investigation.

Does a red flag automatically mean a prescription can never be dispensed?

No.

The pharmacist must investigate the red flag. If the concern is satisfactorily resolved, the prescription may be valid to dispense.

The reason the red flag was resolved should be documented on the prescription or in the appropriate record.

What is the pharmacist's corresponding responsibility?

The pharmacist shares responsibility with the prescriber for ensuring proper prescribing and dispensing.

The pharmacist should dispense only when the prescription satisfies legal and professional requirements.

What kinds of prescription changes may a pharmacist or intern sometimes make without contacting the prescriber?

Depending on state law, simple non-clinical corrections may be allowed, such as missing demographic information like:

• patient address

• date of birth

Clinical or therapeutic issues require prescriber involvement.

Can a nurse or secretary resolve a therapeutic prescription problem on behalf of the prescriber?

Generally no, because therapeutic decisions require clinical judgment.

Therapeutic issues should be resolved with the prescriber or another legally authorized clinician.

What types of errors may make a prescription legally invalid rather than merely needing clarification?

More serious problems may include:

• exceeding refill restrictions

• exceeding quantity restrictions

• use of an illegal prescription format

These may require a new prescription.

What is the key phone-prescription distinction for Schedule II drugs?

A Schedule II prescription generally cannot simply be called in as a new prescription.

A pharmacist may receive an oral Schedule II prescription only in a legally qualifying emergency situation.

For other medications, a new prescription may generally be taken by phone when otherwise permitted by law.