Session 6 - Pharmacy Registration

Registers the actual facility based on function (e.g., Pharmacy, Wholesaler, Manufacturer)

NYSED

Registration required to handle controlled substances within NYS

BNE

Registration required for all facilities handling controlled substances at the federal level

DEA

_______ registers a facility as a pharmacy, limited pharmacy, wholesaler, manufacturer, or outsourcing facility

NYSED

Class 1 BNE registration

Manufacturer

Class 2 BNE registration

Wholesaler

Class 3 BNE registration

Institutional dispenser

Class 11 BNE registration

Automatic dispensing cabinets

Pharmacists are _____ from requiring individual DEA numbers; they utilize the specific DEA number assigned to their employing facility

Exempt

Pharmacy total size must be greater than _____ square feet

300

Pharmacy work area must be greater than _____ square feet specifically dedicated to manufacturing, compounding, and dispensing

100

If the pharmacy is located within a larger store, it must be physically ________

Separated

A registered pharmacy must possess a weighing device sensitive to ____

6 mg

A registered pharmacy must have measuring devices covering this range of volumes

0.1 mL to 500 mL

Pharmacy must maintain a physical copy of this; other references may be electronic

NYS Laws, Rules, and Regulations

Pharmacy registration must be renewed every ___ years

3

For a location change, pharmacy must notify the State ____ ____ prior to a move

30 days

For a disaster, pharmacy must notify the State within ____ _____ of damage resulting from fire, flood, or other disaster

48 hours

For personnel changes, pharmacy should notify the State within ___ _____ of changes regarding officers, directors, or stockholders who own greater than 10% of stock

30 days

The interior of the pharmacy must display the registration certificate containing the name of the ________ _________

Supervising pharmacist

The outside of the pharmacy must display the name of the _______-

Owner

Non-resident pharmacies must provide a toll-free number that is available for more than ____ hours/week during normal business hours

40

Specific thresholds that exempt entities from NYS non-resident registration; includes pharmacies delivering fewer than 600 prescriptions per year into NYS and wholesalers with total sales of less than $10,000 per year into NYS

Isolated transactions

Found in hospitals, nursing homes, or dialysis centers; may only serve patients of that specific facility, cannot serve the public

Limited pharmacies

Only a ______ pharmacy may utilize drugs, medicines, drug store, or pharmacy in their name or advertising

Registered

Includes the 150 most prescribed drugs in their “usual dosage”; pricing reflects the retail price before any discounts, insurance, or coupons

Drug retail price list

The Board of Pharmacy provides the drug retail price list at least _______ to pharmacies and the DOH

Annually

Pharmacies must update their drug retail price list at least _______

Weekly

Each drug retail price list must be date and _____-stamped

Time

DRPL is provided ____ to anyone who requests it

Free

For this, a sign must be posted that is bold/block letters and at least 1 inch high in a conspicuous location, adjacent to the line of sight in the waiting area, or at the Rx-pickup/drop-off counter

Drug retail price list

The drug retail price list must include a _____ ________ encouraging patients to notify their pharmacist/practitioner of all meds to avoid interactions

DOH advisory

Every mail-order prescription delivery must include a ____ regarding the price list and the toll-free number

Notice

If an insurance copay is higher than the DRPL price (or pharmacy usual and customary price), charge the ______ price; applies to all drugs, not just the top 150 list

Lesser

If DRPL price is lower than insurance, the pharmacist must notify the patient of the lower cost and charge that amount if _________

Desired

_____ requires pharmacies to provide info on safe disposal of unwanted medications

DEC

What are the three approved medication disposal methods?

Collection sites, mail-back, and trash

Part of a group of 8 or more pharmacies in NYS owned by the same corporate entity

Covered pharmacy

Pharmacy must provide translation for top ___ non-English languages spoken by at least 1% of NYS population

7

Covered pharmacies must provide ____ written translation and competent oral interpretation if requested by patient or prescription marked “LEP”

Free

Pharmacy is not liable for 3rd-party translation ______ if the contract was made in “good faith” (liability rests with the servicer)

Errors

If a pharmacy has a waiver, they must post a sign indicating the _______ of nearest LEP services

Location

Providing medication or an Rx to the sexual partner(s) of a patient diagnosed with specific STIs without requiring the partner to have a clinical evaluation

EPT

What are the eligible STIs for EPT?

Chlamydia, Gonorrhea, and Trichomoniasis

People co-infected with ________ are excluded from EPT

Syphilis

EPT prescriptions must include EPT designation above the drug name/dosage; also need _________ prescriptions for each individual (cannot reuse index patient’s script)

Separate

Applies to partners exposed within 60 days before the index patient’s symptom onset or most recent partner

EPT

The ______ _______ is responsible for EPT cost; it cannot be processed through insurance

Index patient

For ____, can dispense without the patient name, address, or DOB

EPT

For EPT, use a ______ ________ profile if a specific profile doesn’t exist

Test patient

Allows non-prescription access to syringes/needles for adults 18+; applies to licensed/registered pharmacies in NY, Article 28 facilities, and authorized practitioners

ESAP

Syringes must be _______ to staff areas, out of reach of customers

Restricted

Currently, there is no limit on the number of ______ furnished per transaction

Syringes

Pharmacies are permitted to ________ the sale of hypodermic supplies without a prescription

Advertise

A commissioner-approved _______ ______ must be provided at ESAP sale containing proper use and disposal, risks of blood-borne pathogens, injectable drug use risk/treatment into, HIV number, and legal statement

Safety insert

General hospitals, diagnostic and treatment centers, hospital-based outpatient departments, and residental health care facilities must accept ______ for disposal

Sharps

Facilities may deny sharp disposal if not in an approved, _______-_____ container

Puncture-proof

Filling a medication at a location outside the originating pharmacy

Central fill

To participate in ______ _____ ______, facilities must have the same owner or a written contractual agreement and share a common e-file or dispensing software

Shared pharmacy services

Pharmacists must notify patients of shared services and receive ______ prior to filling via one-time written or electronic form; patients can opt-out at any time

Consent

For shared services, the Rx records must identify every _______ and every individual involved in each step

Pharmacy

NYSED must be notified within ___ _____ if any participating pharmacy in shared services faces disciplinary action from another state’s regulator

30 days

For shared services (central fill), label much identify each ______ involved

Pharmacy