Pharmacy Law - Licensure, Practice, and Operations

A set of vocabulary flashcards covering New York pharmacy law, including personnel roles, prescription requirements, dispensing regulations, and operational standards.

Pharmacist-in-charge (PIC)

The person responsible for all operational aspects of a pharmacy who must work a minimum of $30\text{ hours/week}$ and is limited to supervising only one pharmacy at a time.

DEA Form 106

The official document that must be completed and sent to the DEA within $1\text{ day}$ following the theft or significant loss of controlled substances.

Direct personal supervision

A level of oversight where a supervising licensed pharmacist remains in the immediate area, authorizes procedures, evaluates the work of technicians, and approves all work prior to dispensing.

Pharmacy Limited permit

Also known as an intern permit, it is available to P2-P4 students, is valid for $5\text{ years}$, and may be renewed once for a period of $2\text{ years}$.

Registered Pharmacy Technician Ratio

The maximum allowable ratio of pharmacists to registered pharmacy technicians when technicians are performing tasks within their scope of practice is $1:2$.

Unlicensed support staff ratio

The maximum allowable ratio of pharmacists to unlicensed support staff (including clerks and technicians acting as clerks) is $1:4$.

Continuing Education (CE) Requirements

Pharmacists must complete $45\text{ hours}$ every $3\text{ years}$, of which at least $23\text{ hours}$ must be LIVE and $3\text{ hours}$ must be on reducing medication errors.

Professional Assistance Program (PAP)

A confidential program for professionals struggling with substance abuse who have not harmed patients, allowing for voluntary, temporary license surrender during treatment.

ONYSRX

The Official New York State Prescription Form, which is tamper-resistant and required for all hard-copy prescriptions written in the state.

Code A

A diagnostic code required on a controlled substance prescription to authorize up to a $3\text{-month}$ supply for panic disorder.

Code B

A diagnostic code required on a controlled substance prescription to authorize up to a $3\text{-month}$ supply for Attention Deficit Disorder (ADD).

Code C

A diagnostic code used to authorize up to a $3\text{-month}$ supply of a controlled substance for chronic debilitating neurological conditions or seizure disorders.

Code D

A diagnostic code required on a controlled substance prescription to authorize up to a $3\text{-month}$ supply for chronic pain.

Code E

A diagnostic code required on a controlled substance prescription to authorize up to a $3\text{-month}$ supply for narcolepsy.

Code F

A diagnostic code required on a controlled substance prescription to authorize up to a $3\text{-month}$ supply for hormone-related conditions (or a $6\text{-month}$ supply for anabolic steroids).

Collaborative Drug Therapy Management (CDTM)

A practice protocol where a pharmacist may adjust or manage a patient's drug regimen (strength, frequency, or route) as authorized by a participating physician.

HIV PEP medication dispensing

Under a non-patient-specific order, a pharmacist may dispense up to a $7\text{-day}$ supply of HIV Post-Exposure Prophylaxis to a patient without a prescription.

Critical Elements (Labeling)

Specific label information that must be bolded or in color and in at least $12\text{-point}$ font, including patient name, drug name and strength, and directions for use.

Class 1 Recall

The most serious level of drug recall where the product may cause serious adverse health consequences or death; patients must be notified within $3\text{ days}$.

Drug Retail Price List

A list of the retail prices for the $150\text{ most commonly prescribed drugs}$ that every pharmacy must make available to consumers upon request.

Zero Report

A mandatory submission to the PMP if a pharmacy dispenses $0$ controlled substances during a business day.

Emergency Drug Kit (Nursing Home)

A secured kit containing no more than a $24\text{-hour}$ supply of non-controlled medications and no more than $10\text{ unique controlled substances}$ (limit of $3$ injectables).

Orange Book

The FDA publication used to determine therapeutic equivalence for the purpose of generic drug substitution.

Purple Book

The FDA publication used to identify licensed biological products and their biosimilar or interchangeable status.