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Detailed information on the regulations and requirements surrounding controlled substances in the state of new jersey. It covers topics such as emergency dispensing of cii drugs, partial filling of cii prescriptions, record-keeping and reporting requirements for pharmacies, registration and licensing for controlled substance handling, disposal and destruction procedures, prescribing and dispensing rules for opioids and other controlled medications, and specific regulations related to opioid treatment programs and buprenorphine prescribing. The document delves into the various forms, notifications, and notifications that pharmacies and practitioners must adhere to when dealing with controlled substances in order to comply with state and federal laws. It serves as a comprehensive guide to navigating the complex regulatory landscape for controlled substances in new jersey.
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Examples of schedule I drugs ✔✔-Methaqualone
-Mescaline
-Heroin
-GHB
-LSD
-Marijuana/THC :/
-Peyote
What schedule is amobarbital, pentobarbital, secobarbital? ✔✔CII
What schedule is cocaine? ✔✔CII
What schedule is meth? ✔✔CII
What schedule is nabilone? ✔✔CII
What schedule is hycodan? ✔✔CII
What schedule is hydrocodone-containing products? ✔✔CII
What schedule is codeine? ✔✔CII
What schedule are anabolic steroids? ✔✔CIII
What schedule is fiorinal/codeine? ✔✔CIII
What schedule is dronabinol? ✔✔CIII
What schedule is buprenorphine products? ✔✔CIII
What schedule is Xyrem (GHB, sodium oxybate)? ✔✔CIII
What schedule is modafinil? ✔✔CIV
What schedule is Actified/codeine? ✔✔CV
What schedule is codeine/promethazine and codeine/gauifenesin? ✔✔CV
What schedule is novahistine? ✔✔CV
What schedule is codeine/APAP liquid? ✔✔CV
Max amt. of codeine/dihydrocodeine for CIII? ✔✔NMT 18mg/mL
or
90mg/dosage unit
Max. amt. of ethylmorphine for CIII? ✔✔3mg/mL
or
15mg/dosage unit
Max. amt. of opium for CIII? ✔✔5mg/mL
or
25mg/dosage unit
Max. amt. of liquid morphine for CIII? ✔✔0.5mg/mL
Max amt of codeine for CV? ✔✔2mg/mL
Max amt of dihydrocodeine, ethylmorphine, and opium for CV? ✔✔1mg/mL
Amt of diphenoxylate and atropine for CV? ✔✔NMT 2.5mg diphenoxylate/dose &
NLT 25ug atropine/dose
Amt of difenoxin and atropine for CV? ✔✔NMT 0.5 mg difenoxin &
NLT 25 ug atropine
For partial filling of CII, this must be noted on face of Rx ✔✔Amount dispensed
If the remaining CII balance of a partial fill is not filled within _____ then the pharmacist needs to notify the prescriber -needs new Rx or just let them know ✔✔72 hr
What does the pharmacist need to record for partial filling CIIs? ✔✔1. Date of partial filling
Exceptions to 72 hr rule for partial filling and what is the timeframe? ✔✔LTCFs and terminally ill patients -up to 60 days but pharmacist needs to record this on Rx
What is Comprehensive Addiction & Recovery Act (CARA)? ✔✔It allows the pharmacist to partially fill CIIs for patients not terminally ill or in LTCF, must be requested by patient or prescriber -must fill within 30 days
When can the requirement of red C be waved under federal & NJ law for Rx? ✔✔If pharmacy uses computer system that permits ID by Rx # and retrieval of original documents by prescriber's last name, patient's last name, drug dispensed, date filled
How do control substance Rxs need to be stored? ✔✔CII: separate
CIII-CV: separate OR readily retrievable
What are the 3 methods for storing CII-CVs? ✔✔1. CII /// CIII-CV /// non-controls
When does controlled substance inventory take place in NJ? ✔✔1. Initial business activity (even if 0)
When can controlled substance inventory be taken in NJ? ✔✔1. Day of year when original inventory was taken OR
How are CIII-CV drugs counted? ✔✔Can be estimated UNLESS original container has > 1000 tabs/caps, then you need to take exact count
How long do inventory records need to be maintained? ✔✔2 years
When the biennial controlled inventory is taken, what time of day must it be done? ✔✔Beginning or close of business
For central record keeping in NJ, the records must be available to ✔✔DEA and DCU
How can a pharmacy establish central record keeping? ✔✔1. Notify DEA 14 days in advance in triplicate by registered or certified mail, return receipt requested
Can the DEA show up to unannounced to inspect central records? ✔✔yes
Central record keeping may NOT include the following: ✔✔-prescriptions
-inventory records
-EXECUTED 222 order forms
How to obtain DEA 222 form for CIIs? ✔✔request 222a form and send to DC
How to complete the 3 DEA 222 forms? ✔✔Purchaser keeps copy 3 > mails 1 and 2 to supplier
supplier mails 2 to the DEA upon completion
What to do if you make a mistake on DEA 222 form? ✔✔Mark all 3 copies VOID and store with other executed forms
DO NOT THROW AWAY
Who can sign the DEA 222 form? ✔✔Registrant or someone given power of attorney
How long does the supplier have to fill the order from date of execution to supply balance? ✔✔60 days
What if an option for the supplier if they don't have the item ordered and can't get it? ✔✔Endorse reverse side of DEA 222 form and send to another supplier
Online pharmacies must register with DEA and contact respective state boards within _____ days prior to engaging in internet pharmacy involving controlled substances ✔✔ 30
Who is exempted from definition of online pharmacy? ✔✔Pharmacies registered with DEA who only use internet to refill Rx of CIII-CV or filling new Rx of CIII-CV where pharmacy previously filled non-internet Rx for same patient and patient requests prescriber for new Rx
When do online pharmacies need to report to DEA? ✔✔Monthly report if during the month the pharmacy dispensed at least 100 prescriptions or least 5000 dosage units
Statements required on online pharmacy homepage ✔✔1. Statement that pharmacy complies with Act
What is the Verified Internet Pharmacy Practice Site (VIPPS) and who grants it? ✔✔An accreditation by the NABP that pharmacies can apply for to distinguish themselves from rogue online pharmacies, website displays seal and has .pharmacy domain
In NJ, who needs to be notified by the supplier if all or part of a controlled substance shipment is lost in-transit? ✔✔DEA and DCU
After a purchaser takes custody of a controlled shipment and discovers loss or theft, they must ✔✔submit DEA 106 form
What happens if a pharmacy discovers that an unfilled DEA 222 order form has been lost in- transit? ✔✔Execute another form in addition to statement containing info about original order:
-Serial #
-Date of lost form
-State that goods covered by first order not received thru loss of that order form
-attach statement to all 3 copies
-Retain copy 3 of first and second orders together
-Notify DCU when lost and if found
When do manufacturers and distributors need to register for CS activity with AG and DCU? ✔✔Annually
When can a pharmacy distribute CS to another pharmacy or physician without having to register as a distributor? ✔✔If sales amount to < 5% of all CS dispensed and distributed in 1 yr
Who is exempted from individual registration with DEA? ✔✔-Hospital practitioners given circumstances
-Armed Service officials
-Public Health service officials
-Bureau of Prisons
-Duly authorized law enforcement when possessing CS
How can a pharmacy apply for controlled substance registration? ✔✔Complete 224 form
How can a registrant renew controlled substance registration? ✔✔Online no more than 60 days prior to current exp. date with 224a application
For change of pharmacy address in NJ, must notify ✔✔DEA and DCU in writing
OK as long as no change in ownership
In NJ, what does the DCU consider a change in ownership regarding CS registration? ✔✔- Change in president, CEO or ownership of 10% of outstanding shares
-Needs new application
What happens if registrant dies or ceases legal existence or discontinues business regarding their CS registration? ✔✔DEA must be notified and registration is terminated
CS registration may not be transferred or assigned without ✔✔approval of DEA after submitting written request
Before the DEA suspends or revokes CS registration, they must first ✔✔issue Order to Show Cause
then registrant must deliver certificate and 222 forms to DEA
How can a pharmacy in NJ become a collector to destroy CS? ✔✔-Needs modified DEA registration
Reverse distributors fill out the following forms to collect and destroy CS ✔✔-222 form
-41 form
What did the DEA's Final Rule for the Disposal of CS do? ✔✔Set rules to allow for pharmacies (DEA registrants) to voluntarily decide to establish disposal programs if they are authorized and modify their DEA registrations
How does the registrant notify the DEA if there is theft or significant loss of CS? ✔✔In writing within 1 business day, recommended by fax
What does the pharmacist do if theft or loss was thought to occur but didn't? ✔✔-DO NOT fill out DEA 106 form
-Notify the DEA in writing to explain why no form was filled out
What is the DA 106 form used for? ✔✔Reporting theft or loss of CS
What does a pharmacist do in NJ when CS is lost or stolen? ✔✔-Report to DEA
-Written report filed with Board of Pharmacy, including copy of of 106 form
-Sen copy of 106 form to DCU
What must CS Rx contain? ✔✔-Full name and address of patient
-Drug name, strength, dosage form, quantity, directions
-Name, address, DEA # of prescriber
-Manual prescriber signature, no stamps
How is the name written for a CS for an animal? ✔✔Name & address of owner with pet species
Allowable changes made by pharmacists to CII-CV Rx in NJ? ✔✔-Add patient's address or change address
-Change or add dosage form, strength, quantity, directions, or issue date only after consulting with prescriber
-Add DEA # if missing
In NJ, can Rx be written for CII amphetamine or sympathomimetic amine for use in weight management or fatigue? ✔✔NO
