Jurisprudence NYS Controlled Substance Laws

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What entity is responsible for investigating pharmacists in NYS?

Office of Professional Discipline

What does the OPD inspect?

1. Controlled substance compliance
2. Substitution compliance laws
3. DEA records

In NYS, which Code can be included on a script for Ambien to authorize a greater supply of medication?

None

In a NYS hospital

Controlled substances require the completion of an administration sheet

In a NYS institution what medications may be kept in a medication cart?

Lortab
Ambein

How many people must be identified to conduct and destroy products when applying to the NYS Bureau of Narcotic Enforcement for destruction of controlled substances?

2

What schedule is diazepam?

IV

In NYS, under which circumstances may a schedule II controlled substance prescription be faxed?

1. For a patient in RHCF
2. For a terminally ill patient

Within what time period must the original prescription be delivered to the pharmacy for the above referenced prescription?

72 hours

What action must the pharmacy take if they do not receive the original prescription as stated in Question 10 above?

The pharmacy must notify the Bureau of Narcotic Enforcement in writing that they did not receive the original within 7 days of dispensing

In NYS, an emergency prescription for Lortab may be authorized for a supply of how many days?

5

In NYS, controlled substance prescriptions are valid for how long a period of time?

30 days from the date written

In NYS, what age must a person be to pick up a controlled substance prescription?

18

What is the maximum number of days early a patient in NYS can fill or refill a controlled substance prescription?

7

How many refills may the prescriber authorize on a schedule III controlled substance prescription?

5

What is the patient limit for practitioners who participate in the NYS DATA program?

There is no limit

What information must a pharmacist in NYS add to a controlled substance prescription when the pharmacist fills it?

Date of filling
Pharmacist's signature

Chorionic gonadotropin may be coded for a maximum supply of what quantity?

3 months

Versed is what schedule controlled substance?

IV

All prescriptions for controlled substances must be presented for filling within what period of time?

30 days from the date of issue

How often are controlled substances inventoried in NYS?

Every 24 months

Which code can be used for Ambien in NYS for a 3 month supply?

No code is permissible

What is the maximum quantity of anabolic steroids permissible on a coded prescription in NYS?

6 months supply

What quantity of syringes may be authorized in NYS on an oral prescription?

100

How long must a pharmacy in NYS keep a record of syringe destruction?

2 years

Controlled substance prescriptions in NYS may be refilled up to a total of how many days early?

7 days

All records concerning controlled substances utilized on Advanced Life Support Agency vehicles in NYS are maintained for a period of what time?

5 years

What information does the OPD look for when they do an inspection in NYS?

1. Prescription records
2. Counseling
3. Pharmacist and pharmacy intern identification

If a practitioner requires countersignature on medication orders written by Physician's Assistants, within what period of time must the order be countersigned?

48 hours

Partial filling of Schedule II controlled substance prescriptions in NYS is permissible under what circumstances?

1. Pharmacy does not have enough in stock
2. Patient is terminally ill

Partial filling of a prescription for Lortab in NYS is permissible under what circumstances?

1. Patient requests a lesser quantity than prescribed
2. Pharmacy does not have enough in stock
3. Patient is terminally ill

In NYS, what requires close supervision by a physician?

Physician's Assistant

Article 28 facilitates in NYS are allowed a maximum of how many physician's assistants?

6

In NYS, nurse practitioners utilize what letter as the first letter of their DEA number?

M

Benodiazepines in NYS

Do NOT require an administration sheet and they MAY be stored in a medication cart

Practitioner may prescribe a CS prior to exam if

1. Previously established practitioner/patient relationship
2. Emergency exists
3. Prescription does not exceed a 5-day supply

Schedule II

3 months supply of a CS, including gonadotrophin, or up to 6 month supply of an anabolic steroid for treatment if contains a code

Code A

Panic disorders

Code B

Attention deficit disorder

Code C

Chronic debilitating neurological conditions characterized as a movement disorder or exhibiting seizure, convulsive or spasm activity

Code D

Relief of pain in patients suffering from chronic or incurable pain

Code E

Narcolepsy

Code F

Hormone deficiency states in males, gynecologic conditions that are responsive to treatment with anabolic steroids or chorionic gonadotrophin, metastatic breast cancer in women, anemia and angioedema

RPh cannot add what to a CS Rx?

-Date of Rx
-Signature of the prescriber to the Rx
-Name and/or quantity of the CS
-Name of the ultimate user

RPh does NOT need authorization to add the following to a CS Rx:

-Patient's address
-Sex
-Age
-Provided RPh uses a good faith effort to obtain the information

Emergency Oral Prescriptions

-Oral Rx for CII for 5 day supply according to the directions
-Within 72 hours the prescriber shall deliver the RPh the official NYS Rx
-RPh shall endorse with the date of delivery and their signature
-Oral CII Rx's retained in the pharmacy for 5 years

Schedules III, IV, and V

Refills are allowed
-Not more than 5 refills within a 6 month period of time
-6 months from the date the Rx is issued
-Rx's for a quantity in excess of 30 days pursuant to above may be refilled once

Oral Rx's CIII, IV and V

-5 day supply
-Except for schedule IV (does not include benzos) a 30 day supply or 100 dosage units, whichever is less

Partial fills of CII CS

1. RPh does not have a sufficient quantity to fill an oral or written Rx (Remaining must be filed within 72 hours of 1st partial filling)
2. Patient resident of a Residential Health Care Facility (RHCF)
3. Patient has been diagnosed terminally ill

CS inventory

Inventoried biennially

Syringes/needles

Oral Rx from practitioner, quantity of 100 with written within 72 hours
-Rx valid for 2 years from date written

Authorized CS prescribers

-Certified NP
-Licensed midwives
-Registered PA's

Anabolic steroids that are exempt from the Public Health Law

-Estratest
-Estratest HS
-Premarin with conjugated estrogens

Distributer

Class 2 license

Manufacturers

Class 1 license within the United States

Class 1A license outside of the state and doing business with the state

Importers

Class 9 license and registration from DEA

Importer broker

Class 9A license- no physical possession of CS

Exporters

Class 10 license

Exporter broker

Class 10A license (no physical possession of CS)

Out of state persons conducting distributing activities

Class 2A license

Research of CS in schedules II-V

Class 4 license and registration with DEA

Industrial or commercial processes schedules II-V

Class 4A license and DEA

Conducting research schedule I

Class 7 license and file with the department 3 copies of research protocol

Instructional activities schedules II-V

Class 5 and DEA registration

Analytical laboratories

Class 8 license and DEA

Institutional dispensers

*Hospitals, veterinary hospitals, mental hospitals

Musth ave a license- Class 3 and register with the DEA

Class 3 Institutional dispensers

May purchase stocks of CS only from authorized distributers/manufacturers licensed by the department

Institutional Dispensers

Standing orders valid for 7 days

*Stabilized patient convulsive disorders or chronic spasticity or minimum brain function, RHCF, prison (Class 3 license) valid for 30 days

Benzos in NYS

*Benzodiazepines may be stored in a medication cart
*Benzodiazepines do not require an administration sheet
*Benzodiazepine prescriptions may be stored with CIII-CV prescriptions

Sealed Emergency Medication Kits

*24 hour supply of up to 10 different CS unit dose packaged, no more than 3 in injectable form
*Stored stationary, double-locked system

Disposal of CS records

Must be kept for 5 years

Syringes

Emergency: Oral Rx from practitioner, quantity of 100 with written original within 72 hours

Hypodermic Syringes and Needles

Physical inventory taken each June 30th

Destruction of syringes

Records kept for 2 years

Emergency Medical Services CS

Morphine
Valium
Versed

Helicopters are allowed fentanyl

For what period of time is a PRN controlled substance order in NYS institution valid for?

72 hours

In NYS, what age must a person attain to pick up a controlled substance prescription?

No age requirement

In NYS how many refills may the prescriber authorize on a schedule V controlled substance prescription?

5

In NYS, the remaining quantity of a partially filled schedule II CS for a terminally ill patient is valid for how long from the date written?

60 days

Schedule II by Fax

Patient enrolled in hospice or resident of a Residential Health Care Facility (RHCF) may be transmitted by fax

CII compounded for directed administration to a patient may be faxed

-Parenteral
-IV
-IM
-SC or
-Intraspinal infusion

*Within 72 hours practitioner to deliver to pharmacist original official NYS prescription

RPh cannot add to CII Rx

-Date of the Rx
-Signature of the prescriber to the Rx
-Name and/or quantity of the CS
-Name of the ultimate user

Emergency oral prescriptions

Information filed electronically with BNE not later than the 15th day of the next month following the month the CS was delivered

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