MPJE Book PDF - Controlled Substances

MPJE Sec$on 01: Controlled Substances This sec(on is extremely important in the prepara(on for the MPJE exam. A strong understanding of the competency statements as they relate to controlled substances will provide a strong start to preparing for the MPJE. Just as importantly, NJ law diﬀers from federal law in more than 20 diﬀerent areas dealing with controlled substances. The diﬀerences are carefully pointed out in the margins of the text. 1.1 Schedules (divided depending on their dependence poten(al and abuse poten(al Schedule Physical dependence Psychological dependence I Severe Severe II Severe Severe III Moderate High IV Limited Limited V Limited Limited - Schedule 1 drugs have NO currently accepted medical use o Examples: Methaqualone, Heroin, Mescaline, GHB (Gamma Hydroxybutyric Acid), LSD, Marijuana, Peyote, THC - Schedule 2 examples Amobarbital Cocaine Fentanyl (Duragesic, Ac(q, Fentora, - Note that cocaine is a Lazanda) schedule II substance, NOT schedule I Meperidine (Demerol) Methamphetamine (desoxyn) Morphine Oxycodone (Tylox, Percocet, Pentobarbital (Nembutal) Oxymorphone (Opana) Percodan) Nabilone (Cesamet) Hydrocodone/APAP (Vicodin, Hydrocodone/chlorpheniramine lorcet) (Tussionex) Amphetamines (Dexedrine, Diphenoxylate Hydromorohone (Dilauded) Adderall) Methadone (dolophine) Methylphenidate (Ritalin, MS Con(n Concerta) Oxycon(n Secobarbital (Seconal) Tapentadol (Nucynta) Codeine Hycodan Hydrocodone/ibuprofen (Vicoprofen) Hydrocodone-combina(on products changed from scheduled III to scheduled II eﬀec(ve October 6, 2014 Schedule II substances in suppository form become schedule III substances 1.2 Scheduling Authority - Scheduling authority is vested solely with the A\orney General. However, the a\orney general must ﬁrst request a scien(ﬁc and medical evalua(on of the drug from the secretary of the department of Health and Human Services (HHS). The recommenda(on of the secretary with the regard to medical and scien(ﬁc ma\ers is binding on the A\orney General. However, if the a\orney general ﬁnds that a drug must be placed into schedule I to avoid an “imminent hazard to the public safety,” he/she may do so without consul(ng the Secretary of HHS. 1.3 Emergency (Telephone Order) Dispensing of Schedule II Drugs - Permi\ed if an emergency exists. An emergency exists if o Immediate administra(on of CII substance is necessary o No alterna(ve tx is available (eg: would a CIII work?) o It is not reasonably possible for the prescriber to present a wri\en prescrip(on prior to dispensing o In NJ, the emergency period is speciﬁcally limited to a 72 hours supply - 1.3.1 Requirements related to emergency dispensing o The quan(ty dispensed should only be enough to get the pa(ent through the emergency period o The prescrip(on must be immediately reduced to wri(ng o A reasonable eﬀort must be made to ascertain that the oral authoriza(on came from a registered individual prac((oner o Within 7 days, the physician must have delivered (or postmarked) a prescrip(on to the pharmacy, with the words “Authoriza9on for emergency dispensing.” Note the diﬀerence in Pa. law in the margin. o The pharmacist must a\ach the wri\en prescrip(on to the oral emergency wri\en prescrip(on that has been reduced to wri(ng o Failure of the physician to deliver a wri\en prescrip(on requires that the pharmacist no(fy the DEA o Failure to no(fy the DEA voids the authority of the pharmacy to accept emergency oral orders for Schedule II Substances o In NJ, if the pracJJoner does not deliver a prescripJon to cover the emergency quanJty within 7 days, the pharmacy must contact the DEA AND the DCU. Failure of the pharmacist to do so shall void the authority to accept emergency CII prescripJons 1.4 ParJal ﬁlling of Schedule II PrescripJons when pharmacy does not have enough stock to ﬁll prescripJon The amount dispensed must be noted on the face of the prescrip(on. If the balance is unable to be ﬁlled or is not ﬁlled within 72 hours, the pharmacist must no(fy the prescriber--either to get a new prescrip(on for the balance owed or to let him/her know that the Rx was not completely ﬁlled. 1.4.1 ExcepJons to the 72 hour rule for parJal ﬁlling 1.4.1.1 Long Term Care Facili(es - Long-term care facili(es may dispense par(al quan((es of schedule II prescripJons up to 60 days. 1.4.1.2 Terminally Ill Pa(ents - Pharmacists may also dispense par(al quan((es of schedule II prescripJons up to 60 days to pa(ents with a medical diagnosis documen(ng a terminal illness. If there is any doubt whether the pa(ent has a terminal illness, the pharmacist should call the prescriber. - For either the LTCF or terminally pa(ent, for any par(ally ﬁlled schedule II drug, the pharmacist must record: o The date of the par9al ﬁlling o Quan(ty dispensed o Remaining quan9ty authorized to be dispensed o The iden9ﬁca9on of the dispensing pharmacist 1.4.1.3 Par(al ﬁlls of Schedule II drugs requested by Pa(ent or Prescriber - The Comprehensive Addic(on and Recovery Act (CARA) also allows a pharmacist to par(al ﬁll Schedule II drugs when requested by the pa(ent or prescriber, as long as the prac(ce is not prohibited by state law. Any remaining porJon must be ﬁlled within 30 days that prescripJon was issued. - The pharmacist must record on the prescrip(on whether the pa(ent is terminally ill or an LTCF pa(ent - Having to notate the remaining quan(ty may seem unusually but it is simply a housekeeping measure to insure that the total quan(ty on the original prescrip(on is not exceeded - DEA requires real (me upda(ng of computer info and ability to readily retrieve orginal Rx info and lis(ng of all par(al ﬁlls 1.5 ParJal Filling of CIII-CV - Par(al ﬁlling of CIII through CV is permissible provided that: o Each par(al ﬁlling is recorded in the same manner as a reﬁll o Total quan(ty prescribed in all par(al ﬁllings does not exceed the total quan(ty prescribed o No dispensing occurs beyond 6 months afer the prescrip(on is issued - Do not confuse parJal ﬁlling of a CIII-CV with a reﬁll of same. Only 5 reﬁlls are allowed but greater than 5 parJal ﬁllings are allowed. 1.6 Filing Methods for Controlled Drug PrescripJons - Prescrip(ons for Schedule II substances shall be maintained in a separate prescrip(on ﬁle. Prescrip(ons for Schedule III, IV, and V substances shall be maintained in a separate ﬁle only or in such form that they are “readily retrievable” from the other prescrip(on records of the pharmacy. Prescrip(ons are deemed “readily retrievable” if at the (me they are ini(ally ﬁlled: o The face of the prescrip(on is stamped in red ink in the lower right corner with the le\er “C” no less than one inch high and; o Filed in the prescrip(on ﬁle for controlled substances listed in schedule II, or o In the usual consecu(vely numbered prescrip(on ﬁle for non-controlled substances - NJ: However, if a pharmacy employs a computer system for prescripJons that permits idenJﬁcaJon by prescripJon number and retrieval of original documents by prescriber’s name, paJent’s name, drug dispensed, and date ﬁlled, then the requirement to mark the hard copy with the red C is waived under federal law, and under New Jersey law. Note that a Red "C" would not be required for the ﬁling method in the ﬁrst row since the III-V would be readily retrievable since they are already separated. 1.7 Inventory Requirements for Controlled Substances - Before a pharmacy commences business, an iniJal inventory must be taken (even if inventory is zero). The inventory must contain a complete and accurate count of all controlled substances “on hand” i.e., in the possession of, or under the control of the registrant - Biennial (every 2 years) inventory requirements apply to controlled substances. Afer the ini(al inventory is taken, the registrant shall take a new inventory on any date that is within two years of the previous biennial inventory date (note the diﬀerent rule in NJ) - Newly scheduled drugs must be inventoried the day they become scheduled and then again with the next scheduled biennial inventory. It is the pharmacists' responsibility to know when a drug will become newly scheduled - Schedule I and II drugs need to be counted exactly - Schedule III, IV, and V drug counts can be esJmated unless the original container from the manufacturer contained MORE THAN 1,000 tablets or capsules, in which case an EXACT COUNT must be taken - Inventory records must be maintained for 2 years at the inventory loca(on - Ok to record inventory as long as it is promptly transcribed - Inventory must be taken at beginning or close of business and (me must be recorded on inventory record - Recommended, but not required to record signatures of those taking the inventory (note diﬀerence in NJ) - Inventory must be taken if there is a change in ownership - Inventory records for CII must be kept separately - Inventory records for CIII-V must be “readily retrievable In NJ, the inventory date can be on - Day of the year on which original inventory was taken, or - Regular general physical inventory date, which is nearest to and does not vary by more than 6 mos. from date that would otherwise apply. - Any other ﬁxed date using same 6 mo. Rule For allowance of either 6-mo rule applicaJon, registrant must noJfy the DEA and DCU of the date that the inventory will be taken. Similarly, in NJ the pharmacy can take the CS inventory on a date that is within 4 days of the biennial date as long as the DCU is noJﬁed as to the date the inventory was taken when the pharmacy renews its DCU annual registraJon. NJ also requires an inventory to be taken for a change in the PIC, which must be taken by both the incoming PIC and the outgoing PIC. If outgoing PIC is not available can use alternate, but must explain to Board. In NJ, the PIC is required to sign the inventory, even if he/she was not the one conducJng the inventory. Controlled substance inventories are not mailed to any agency. Similarly, in NJ the pharmacy can take the CS inventory on a date that is within 4 days of the biennial date as long as the DCU is noJﬁed as to the date the inventory was taken when the pharmacy renews its DCU annual registraJon NJ also requires an inventory to be taken for a change in the PIC Controlled substance inventories are not mailed to any agency 1.8 Central Recordkeeping For certain registrants (e.g., chain pharmacies) it may be more feasible for them to store controlled substance records at a central loca(on. This is permi\ed by the DEA provided that they are no(ﬁed 14 days in advance, in triplicate, by registered or cer(ﬁed mail, return receipt requested (assuming of course, that they don’t deny the request). - One must tell the DEA what records will be kept centrally, their exact loca(on, name, address, DEA number, and type of registra(on, and whether manual or computerized, and any access codes, etc. - Upon wri\en request from the DEA, the registrant must provide requested central records to the registered locaJon within 2 business days. Alterna(vely, the DEA can show up unannounced and inspect records at the central record keeping site without a warrant of any kind - Failure to comply with the above condi(ons may result in the Special Agent in charge of the Administra(on canceling the central record keeping authorizaJon without a hearing In NJ must make the records available to the DCU in addiJon to the DEA. Note: Central Record Keeping may not include PrescripJons, Inventory Records, and Executed 222 order forms. Central Record Keeping may include unexecuted 222 order forms. 1.9 Ordering Procedure for Schedule II Substances (DEA Form 222) - Order forms may be requisi(oned by using DEA form 222a, which when completed are sent to the Registra(on Unit of the DEA in Washington, DC. - When compleJng a single sheet DEA 222 order form, the pharmacy must make a copy of the original DEA 222 form for its records. This copy may be in electronic or paper form. Upon ﬁlling the order, the supplier retains the original copy for their records and submits a copy to the DEA. - No altera(ons, erasures, or “white-outs” are permi\ed. If a mistake is made, simply mark the DEA 222 form “VOID” and store with other executed order forms.DO NOT THROW AWAY THE DEA 222 FORM CONTAINING THE ERROR. - The DEA 222 order form may be signed by the registrant or by someone who has been given the power of aborney to execute the form - If an order cannot be ﬁlled completely, the supplier has 60 days from the date of the execu(on of the order form to supply the balance - The supplier can also “endorse” the reverse side of the DEA 222 order form to another supplier if they don’t have the item ordered. - Order forms for Carfentanil, Etorphine Hydrochloride, and Diprenorphine shall contain only these substances - It is very important for the purchaser to record the number of containers received and the date received on Part 5 of the DEA - A purchaser may cancel part or all of an order by no(fying the supplier in wri(ng. The supplier must indicate the cancella(on by drawing a line through and marking the item “cancelled” - A supplier may void part or all of an order on a DEA Form 222 by no(fying the pharmacy in wri(ng. The supplier must indicate the voiding on the original DEA Form 222 by drawing a line through the cancelled item(s) and prin(ng “void” in the space provided for the number of items shipped. Addi(onally, the supplier would send the original 222 order form back to the pharmacy along with an explana(on. The pharmacy would retain the voided 222 form and the explana(on in its records. Note that the pharmacy cannot cancel a line item on its own by drawing a line and marking the item “cancelled” A pharmacist or pharmacist manager is not automaJcally eligible to complete a 222 form. If you are not the registrant, then in order for you to be able to order on a DEA 222 order form, there needs to be a completed power of aborney allowing you to do that. 1.9.1 Single Sheet 222 Form Replaces former triplicate form On September 30, 2019 the DEA issued a ﬁnal rule announcing the replacement of the 222 triplicate order form with the single sheet 222 order form. There was a 2-year transi(on period, which allowed pharmacies to exhaust their exis(ng stock of triplicate order forms. However, once a pharmacy’s stock of triplicate forms was exhausted, even if it was before the transi(onal 2-year period ended, the DEA did not be provide any more triplicate forms, but rather only single sheet forms. Similarly, at the end of the 2-year transi(on period, if a pharmacy s(ll had triplicate forms on hand, it would not be able to use them. The new single sheet DEA 222 form is on an 81/2 x 11 inch sheet and expands the number of items that may be ordered from 10 to 20. 1.10 Controlled Substance Ordering Systems (CSOS) Electronic Order Forms Any registrant permi\ed to order schedule II controlled substances may do so electronically via the DEA Controlled Substance Ordering System (CSOS) and maintain the records of these orders electronically for two years. The use of electronic orders is opJonal; registrants may conJnue to issue orders on a paper DEA Form 222. CSOS allows for secure electronic transmission of controlled substance orders without the suppor(ng paper DEA Form 222. CSOS uses Public Key Infrastructure (PKI) technology, which requires CSOS users to obtain a CSOS digital cerJﬁcate for electronic ordering. The electronic orders must be signed using a digital signature issued by a CerJﬁcaJon Authority (CA) run by the DEA. When a purchaser receives a shipment, the purchaser must create a record of the quan(ty of each item received and the date received. The record must be electronically linked to the original order and archived. Digital cer(ﬁcates can be obtained only by registrants and individuals granted power of a\orney by registrants to sign orders. A registrant must appoint a CSOS coordinator who will serve as that registrant's recognized agent regarding issues pertaining to issuance of, revoca(on of, and changes to, digital cer(ﬁcates issued under that registrant's DEA registra(on. A CSOS digital cer(ﬁcate will be valid un(l the DEA registra(on under which it is issued expires or un(l the CSOS CA is no(ﬁed that the cer(ﬁcate should be revoked. Cer(ﬁcates will be revoked if the cer(ﬁcate holder is no longer authorized to sign schedule II orders for the registrant, if the informa(on on which the cer(ﬁcate is based changes, or if the digital cer(ﬁcate used to sign electronic orders has been compromised, stolen, or lost. - Think of the digital cer(ﬁcate as the electronic equivalent of a DEA 222 form 1.10.1 Unaccepted and DefecJve Electronic Orders An electronic order for controlled substances may not be ﬁlled if any of the following occurs: - The required data ﬁelds have not been completed - The order is not signed using a digital signature issued by DEA - The digital cer(ﬁcate used has expired or been revoked prior to signature - The purchaser’s public key will not validate the digital cer(ﬁcate - The valida(on of the order shows that the order is invalid for any reason If an order cannot be ﬁlled, the supplier must no(fy the purchaser and provide a statement as to the reason (e.g., improperly prepared or altered). A supplier may, for any reason, refuse to accept any order. If a supplier refuses, a statement that the order is not accepted is suﬃcient. When a purchaser receives an unaccepted electronic order from the supplier, the purchaser must electronically link the statement of nonacceptance to the original order. The original statement must be retained for two years. Neither a purchaser nor a supplier may correct a defec(ve order. The purchaser must issue a new order for the order to be ﬁlled. 1.10.2 CancellaJon and Voiding of Electronic Orders A supplier may void all (or part) of an electronic order by no(fying the purchaser of the voiding. If the en(re order is voided, the supplier must make an electronic copy of the order and indicate “Void” on the copy and return it to the purchaser. The supplier is not required to retain a record of orders that are not ﬁlled. The purchaser must retain an electronic copy of the voided order. Should a supplier par(ally void an order, the supplier must indicate in the linked record that nothing was shipped for each item voided. 1.10.3 Lost Electronic Orders If a purchaser determines that an unﬁlled electronic order has been lost before or afer receipt, the purchaser must provide, to the supplier, a signed statement. This statement must include the unique tracking number and date of the lost order and state that the goods covered by the ﬁrst order were not received through loss of that order. If the purchaser executes a new order to replace the lost order, the purchaser must electronically link an electronic record of the second order and a copy of the statement with the record of the ﬁrst order and retain them both. If the supplier to whom the order was directed subsequently receives the ﬁrst order, the supplier must indicate that it is “not accepted” and return it to the purchaser. The purchaser must link the returned order to the record of that order and the statement. 1.10.4 DEA records for Electronic Orders For each electronic order ﬁlled, a supplier must forward either a copy of the electronic order or an electronic report of the order in a format that DEA speciﬁes to DEA within two business days. 1.11 Electronic PrescripJons for Controlled Substances The ﬁnal rule on Electronic Prescrip(ons for Controlled Substances became eﬀec(ve June 1, 2010. The rule provides prac((oners with the op(on of wri(ng prescrip(ons for controlled substances electronically and for pharmacies to receive, dispense, and archive these electronic prescrip(ons. Persons who wish to dispense controlled substances using electronic prescrip(ons must select sofware that meets the requirements of this rule. Only those electronic pharmacy applica(ons that comply with all of DEA’s requirements as set forth in 21 C.F.R. §1311 may be used by DEA-registered pharmacies to electronically receive and archive controlled substances prescrip(ons and dispense controlled substances based on those prescrip(ons. 1.11.1 MeeJng DEA ApplicaJon Requirements A pharmacy cannot process electronic prescrip9ons for controlled substances un9l its pharmacy applica9on provider obtains a third party audit or cer9ﬁca9on review that determines that the applica9on complies with DEA’s requirements and the applica9on provider provides the audit/cer9ﬁca9on report to the pharmacy. The audit report the pharmacy will receive from the pharmacy applica(on provider will indicate if the applica(on is capable of impor(ng, displaying, and storing DEA-required prescrip(on informa(on accurately and consistently. If the third-party auditor or cer(ﬁca(on organiza(on ﬁnds that a pharmacy applica(on does not accurately and consistently import, store, and display other informa(on required for prescrip(ons, the pharmacy must not accept electronic prescrip(ons for controlled substances that are subject to the addi(onal informa(on requirements. For example, un(l the audit or cer(ﬁca(on report indicates that the pharmacy applica(on can import, display, and store both a hospital DEA number and the individual prac((oner’s extension number, the pharmacy must not accept electronic prescrip(ons that include only a hospital DEA registra(on number. The pharmacy may, however, use the applica(on to process other controlled substance prescrip(ons if the audit or cer(ﬁca(on report has found that the pharmacy applica(on meets all other requirements. When a pharmacist ﬁlls a prescrip(on in a manner that would require a nota(on on the prescrip(on if the prescrip(on were a paper prescrip(on, the pharmacist must make the same nota(on electronically when ﬁlling an electronic prescrip(on and retain the annota(on electronically in the prescrip(on record or linked ﬁles. When a prescrip(on is received electronically, the prescrip(on and all required annota(ons must be stored electronically. 1.11.2 Simultaneous Paper and Electronic PrescripJons--Avoiding Duplicate Filling When a pharmacist receives a paper or oral prescrip(on that indicates that it was originally transmi\ed electronically to the pharmacy, the pharmacist must check the pharmacy’s records to ensure that the electronic version was not received and the prescrip(on dispensed. If both prescrip(ons were received, the pharmacist must mark one as void. When a pharmacist receives a paper or oral prescrip(on that indicates that it was originally transmi\ed electronically to another pharmacy, the pharmacist must check with that pharmacy to determine whether the prescrip(on was received and dispensed. If the pharmacy that received the original electronic prescrip(on had not dispensed the prescrip(on, that pharmacy must mark the electronic version as void or cancelled. If the pharmacy that received the original electronic prescrip(on dispensed the prescrip(on, the pharmacy with the paper version must not dispense the paper prescrip(on and must mark the prescrip(on as void 1.11.3 Prescriber 2-factor AuthenJcaJon Prescribers wri(ng prescrip(ons for controlled substances are required to use a two-factor authen(ca(on. The DEA is allowing the use of two of the following – something you know (a knowledge factor such as a password), something you have (a hard token stored separately from the computer being accessed), and something you are (biometric informa(on). 1.12 Ryan Haight Online Pharmacy Consumer ProtecJon Act This Act amends the CSA to prevent the illegal distribu(on of CS on the Internet. Eﬀec(ve 4/13/09, pharmacies must get a modiﬁcaJon of exis(ng DEA registraJon to allow opera(on of an online pharmacy. It also imposes repor(ng and disclosure requirements, (see below). Online pharmacies must register with the DEA 30 days prior to engaging in Internet pharmacy involving controlled substances. In addiJon, online pharmacies must contact the respecJve boards of pharmacy for all the states they wish to do business in at least 30 days prior as well. 1.12.1 ExempJons Exempted from the deﬁni(on of “online pharmacy” are pharmacies registered with the DEA whose dispensing of controlled substances via the Internet consist solely of reﬁlling prescrip(ons for CS in schedule III, IV, or V; or ﬁlling new prescrip(ons in schedule III, IV, or V where the pharmacy had previously ﬁlled a non-internet prescrip(on for the same pa(ent and at the pa(ent’s request contacts the prescriber for a new prescrip(on. Signiﬁcantly, this means that the majority of brick-and-mortar pharmacies that also maintain a website are not considered "online pharmacies" and therefore not subject to the onerous disclosure and repor(ng requirements. 1.12.2 AddiJonal Requirements A statement must be placed on the pharmacy’s home page that includes: Statement that the pharmacy complies with the Act Name, address, e-mail address, and telephone number of the pharmacy Name, professional degree, and states of licensure for the pharmacist-in-charge, and a telephone number at which the PIC may be contacted List of states in which the pharmacy is licensed Cer(ﬁca(on that pharmacy is registered with DEA as an online pharmacy The name, address, tele. #, professional degree, and states of licensure of any prac((oner who has a contractual rela(onship with the pharmacy The following statement must also be posted: “This online pharmacy is obligated to comply fully with the Controlled Substances Act and DEA regula(ons. As part of this obliga(on, this online pharmacy has obtained a modiﬁed DEA registra(on authorizing it to operate as an online pharmacy. In addi(on, this online pharmacy will only dispense a controlled substance to a person who has a valid prescrip(on issued for a legi(mate medical purpose based upon a medical rela(onship with a prescribing prac((oner. This includes at least one prior in- person medical evalua(on in accordance with sec(on 309 of the Controlled Substances Act (21 U.S.C. § 829), or a medical evalua(on via telemedicine in accordance with sec(on 102(54) of the Controlled Substances Act (21 U.S.C. § 802(54)).” Monthly reports must be made to the DEA of the quanJty of each CS dispensed by the pharmacy, if, during the month in quesJon, the pharmacy has dispensed at least 100 prescripJons or at least 5,000 dosage units. ReporJng is by NDC number. Keep in mind that most pharmacies are exempt from these requirements because they are exempted from the deﬁniJon of online pharmacy. 1.12.3 Veriﬁed Internet Pharmacy PracJce Sites In addi(on to the DEA requirements for dispensing controlled substances from an online pharmacy, a Veriﬁed Internet Pharmacy PracJce Site (VIPPS) accreditaJon is available from NABP. Pharmacies can apply for this accredita(on and can iden(fy themselves as legi(mate online pharmacies, and dis(nguish themselves from poten(al rogue pharmacies. On line pharmacies must ﬁrst obtain veriﬁca(on by showing compliance with licensing and inspec(on requirements of each state in which they operate; mee(ng na(onally endorsed standards of pharmacy prac(ce; demonstra(ng compliance with standards of privacy and authen(ca(on and security of prescrip(ons; adhering to a quality assurance policy; and providing meaningful consulta(on between pa(ents and pharmacists. Once veriﬁed, pharmacies obtain a.pharmacy domain for their website (e.g. www.mainstreet.pharmacy) instead of (mainstreetpharmacy.com) VIPPS accredited pharmacies also display the VIPPS seal on their respec(ve websites. 1.13 In Transit Losses When all or part of an in-transit shipment of controlled substances fails to reach its intended des(na(on, the supplier is responsible for reporJng the in-transit loss of controlled substances to DEA. The purchaser is responsible for reporJng any loss of controlled substances ager he/she has signed for or taken custody of a shipment. If it is discovered afer that point that an in-transit loss or thef has occurred; the purchaser must then submit a DEA Form 106. If the purchaser does not take custody of the shipment and instead returns it to the supplier, it is the supplier’s responsibility for repor(ng any loss of controlled substances in the original shipment. 1.13.1 In Transit loss from Central Fill Pharmacy When a central ﬁll pharmacy contracts with private, common or contract carriers to transport ﬁlled prescrip(ons to a retail pharmacy, the central ﬁll pharmacy is responsible for repor(ng the in-transit loss upon discovery of such loss by use of a DEA Form 106. In addi(on, when a retail pharmacy contracts with private, common or contract carriers to retrieve ﬁlled prescrip(ons from a central ﬁll pharmacy, the retail pharmacy is responsible for repor(ng in-transit losses upon discovery using a DEA Form 106. Whoever has custody of the CS determines who needs to report losses. If a pharmacy has not signed oﬀ on a delivery, then the supplier would have to report any in transit losses. Similarly, in the case of central ﬁlling, whichever party (i.e., retail pharmacy or central ﬁll pharmacy) that contracts with Fed Ex etc. would be responsible to report any in-transit losses. In New Jersey, the DCU must also be noJﬁed in the event of in transit losses 1.14 Lost or Stolen Order Forms 1.14.1 Order Forms Lost or Stolen in Transit If a pharmacy determines that an unﬁlled DEA 222 order form has been lost, the pharmacy executes another order form and in addi(on, a\aches a statement to it containing the following informa(on about the original order: The order form number The date of the lost form A statement sta(ng that the goods covered by the ﬁrst order form were not received through loss of that order form A copy of the second form and a copy of the statement must be retained with a copy of the original order at the pharmacy. If the original DEA form 222 is subsequently received by the supplier, the supplier must mark it "not accepted’’ and return the original DEA 222 form to the pharmacy, which must a\ach it to the statement being retained at the pharmacy. The purpose of the notes is to alert everyone in the process of a potenJal issue, from the wholesaler to the DEA inspector who may be checking the pharmacy and wondering why the original 222 order form has not been marked with the number of packages received and date received. 1.14.2 Order Forms Lost or Stolen (Used or Unused—Not in Transit) Whenever any used or unused order forms are stolen or lost (otherwise than in the course of transit) by any purchaser or supplier, he/she shall immediately upon discovery of such thef or loss, report the same to the Special Agent in Charge of the Drug Enforcement Administra(on in the Divisional Oﬃce responsible for the area in which the registrant is located, sta(ng the serial number of each form stolen or lost. If the thef or loss includes any original order forms received from purchasers and the supplier is unable to state the serial numbers of such order forms, he/she shall report the date or approximate date of receipt thereof and the names and addresses of the purchasers. If an en(re book of order forms is lost or stolen, and the purchaser is unable to state the serial numbers of the order forms contained therein, he/she shall report, in lieu of the numbers of the forms contained in such book, the date or approximate date of issuance thereof. If any unused order form reported stolen or lost is subsequently recovered or found, the Special Agent in Charge of the Drug Enforcement Administra(on in the Divisional Oﬃce responsible for the area in which the registrant is located shall immediately be no(ﬁed. Whenever any used or unused forms are stolen or lost by any purchaser or supplier, the purchaser or supplier must also noJfy the DCU immediately. Similarly, if any form is found that was reported as stolen or lost, the DCU gets noJﬁed immediately. Although there is no requirement that 222 forms be used sequenJally, it certainly makes sense to do so, considering the reporJng requirements listed for lost and/or stolen order forms. 1.15 RegistraJon for Controlled Substance AcJvity 1.15.1 RegistraJon Requirements Currently, Pharmacies are required to register with the A\orney General every 3 years (Triennially) Pharmacists are not required to register individually Separate registra(ons for each pharmacy owned or operated by the same ﬁrm are required under DEA regula(ons. However, a hospital registered with the DEA generally does not need to have separate DEA registra(ons for decentralized pharmacy services or for satellite pharmacies if they are all part of the same physical structure. A hospital would have to obtain a separate registra(on for any retail pharmacy that they operated for servicing the public. Manufacturers and Distributors must register Annually Generally, a separate registra(on is required for each ac(vity; however, certain coincidental ac(vi(es do not require separate registra(on. For example, a manufacturer need not register as a distributor to distribute their products to the wholesaler Similarly, a pharmacy may “distribute” controlled substances to another pharmacy or physician, for example, without having to register as a distributor, provided that such sales amount to less than 5% of all controlled substances dispensed and distributed in a year Pharmacies must also provide the DUC with the Federal DEA number within 60 days of registraJon Separate registraJons are normally required for: Manufacturing DistribuJng Reverse distribuJng Dispensing/instrucJng Research ImporJng ExporJng NarcoJc treatment program Chemical analyses Manufacturers, wholesalers, and Pharmacies in New Jersey must register annually with the DCU. 1.15.2 ExempJons from RegistraJon Individual prac((oners must ordinarily be registered with the DEA to prescribe controlled substances. (e.g., physicians, den(sts, veterinarians, etc.); however, if the individual prac((oner is an agent or employee of a hospital or other ins(tu(on, the prac((oner may, while ac(ng in the normal course of business or employment, administer, dispense, and prescribe controlled substances under the registra(on of the hospital or ins(tu(on provided that: The dispensing, administering, or prescribing is done in the usual course of professional prac(ce The individual prac((oner is authorized or permi\ed to do so by the jurisdic(on in which he is prac(cing The hospital or other ins(tu(on by which prac((oner is employed has veriﬁed that the prac((oner is so permi\ed to dispense, administer, or prescribe drugs within the jurisdic(on The individual prac((oner is ac(ng only within the scope of his employment in the hospital or ins(tu(on The hospital or ins(tu(on or other ins(tu(on authorizes the intern, resident, or foreign-trained physician to dispense or prescribe under the hospital registra(on and designates a speciﬁc internal code number for each intern, resident, or foreign-trained physician so authorized.The code number shall consist of numbers, le\ers, or a combina(on thereof and shall be a suﬃx to the ins(tu(on’s DEA registra(on number, preceded by a hyphen (e.g., AP 0123456-10) or (AP 0123456-A12) The list of codes and respec(ve prac((oners is made available to other registrants and law enforcement agencies Also exempted from individual registra(on are physicians who are oﬃcials of the Armed Services, Public Health Service, and Bureau of Prisons, who are also allowed to dispense, administer, and prescribe in the usual course of their oﬃcial du(es. Other duly authorized law enforcement personnel are exempt from registra(on for possession of controlled substances as part of their oﬃcial du(es. 1.15.3 Controlled Substance RegistraJon ApplicaJon Pharmacy ini(ally completes applica(on (DEA 224 Applica(on Form). No person may engage in an ac(vity for which registra(on is required un(l applica(on for registra(on is granted and a cer(ﬁcate of registra(on is issued. A registrant can renew online no more than 60 days prior to the current expira(on date by comple(ng a DEA 224a applicaJon. If the registrant has not renewed online approximately 50 days before the registra(on expira(on date, a renewal applica(on is sent to the registrant at the mailing address listed on the current registra(on. If the renewal form is not received by the 30th day before the expira(on date of the current registra(on, the pharmacy should contact the local DEA Registra(on Specialist or DEA Headquarters. 1.15.4 ModiﬁcaJon, TerminaJon, and Transfer of RegistraJon For modiﬁcaJons of registraJon, (e.g., Change of address, addi(on of schedules), must no(fy the DEA in wri(ng. If approved, the DEA will issue a new cer(ﬁcate, which must be maintained with the old cer(ﬁcate. If an individual registrant dies, or if an individual registrant (or corpora(on) ceases legal existence, or discon(nues business, the DEA must be no(ﬁed and the registraJon terminated. No registraJon may be transferred or assigned without the approval of the DEA afer submivng a wri\en request. Do not confuse this transfer with the transfer of business ac(vity to another registrant when a pharmacy goes out of business, for example. 1.15.5 Denial of RegistraJon The A\orney General may deny a registra(on to dispense controlled substances if it is determined that the registra(on would not be in the public interest. 1.15.6 RevocaJon or Suspension of RegistraJon The registra(on may be suspended/revoked by the A\orney General if the applicant has: - Materially falsiﬁed the applica(on - Has been convicted of a felony rela(ve to controlled substances - Has had a state license or registra(on suspended, revoked, or denied Before a suspension or revoca(on, the DEA must ﬁrst issue an Order to Show Cause upon the registrant, who then must deliver the Cer(ﬁcate of Registra(on and all 222 Forms to the DEA, and at the direc(on of the DEA, either deliver all controlled substances to the DEA or keep them under seal. Retail pharmacies installing and operaJng automated dispensing systems at long term care faciliJes must maintain a separate registraJon at the locaJon of each long term care facility at which automated dispensing systems are located. For change of address in NJ, must noJfy the DCU in wriJng with date of change; ok as long as no change in ownership. In NJ for a corp or partnership, the DCU will consider the change in President or CEO or a change in ownership of 10% of the outstanding shares. If so, new applicaJon required. An Order to Show Cause simply means that the DEA is required to provide you an opportunity to defend yourself and with the Order is asking you to give a good reason why the DEA should not revoke/suspend your license. 1.16 Controlled Substance DestrucJon Any registered pharmacy in lawful possession of a controlled substance in its inventory that desires to dispose of that substance shall do so in one of the following ways: Promptly destroy that controlled substance using an on-site method of destruc(on; (Keep in mind that this op(on is only available to pharmacies that have modiﬁed DEA registra(ons that allow them to be collectors). Promptly deliver that controlled substance to a reverse distributor's registered loca(on by common or contract carrier pick-up or by reverse distributor pick-up at the registrant's registered loca(on; For the purpose of return or recall, promptly deliver that controlled substance by common or contract carrier pick-up or pick-up by other registrants at the registrant's registered loca(on to: The registered person from whom it was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer to accept returns or recalls on the manufacturer's behalf; or Request assistance from the Special Agent in Charge of the Administra(on in the area in which the prac((oner is located. The request shall be made by submivng one copy of the DEA Form 41 to the Special Agent in Charge in the prac((oner's area. The form is available online at h\p://www.DEAdiversion.usdoj.gov under the heading "DEA Forms and Applica(ons.” The DEA Form 41 shall list the controlled substance or substances which the registrant desires to dispose. The Special Agent in Charge shall instruct the registrant to dispose of the controlled substance in one of the following manners: By transfer to a registrant authorized to transport or destroy the substance; By delivery to an agent of the Administra(on or to the nearest oﬃce of the Administra(on; or By destruc(on in the presence of an agent of the Administra(on or other authorized person. The DEA form 41 must be used to record the destruc(on of all controlled substance inventories, as well as the destruc(on of controlled substances that are collected from ul(mate users. A pharmacy would need to have a modiﬁed DEA registraJon and be classiﬁed as a "collector" in order to do on site destrucJon. In addiJon, in New Jersey the pharmacy is required to noJfy the DCU within 5 days if it becomes a collector, and similarly to noJfy the DCU within 5 days of any subsequent change to that status. If an onsite destrucJon occurs, 2 employees of the registrant shall handle or observe the handling of any controlled substance unJl the substance is rendered non-retrievable; and 2 employees of the registrant shall personally witness the destrucJon of the controlled substance unJl it is rendered non-retrievable. The pharmacy shall maintain a record of destrucJon on a DEA Form 41. The records shall be complete and accurate, and include the name and signature of the 2 employees who witnessed the destrucJon. Spilled or damaged controlled substances that are recoverable are required to be destroyed using one of the accepted destrucJon methods listed and get reported on a DEA 41 Form; non recoverable controlled substances (e.g., accidentally spilled down the sink) are simply recorded in the controlled substance records (2 witnesses needed) and a DEA 41 is completed. 1.16.1 Blanket AuthorizaJon for DestrucJon of Controlled Substances In the event that a registrant is required regularly to dispose of controlled substances, (e.g., hospital) the Special Agent in Charge may authorize the registrant to dispose of such substances, without prior approval of the DEA in each instance, on the condi(on that the registrant keep records of such disposals and ﬁle periodic reports with the Special Agent in Charge summarizing the disposals made by the registrant. In gran(ng such authority, the Special Agent in Charge may place such condi(ons as he deems proper on the disposal of controlled substances, including the method of disposal and the frequency and detail of reports. A DEA Form 41 should not be used to record the transfer of controlled substances between the pharmacy and the reverse distributor disposing of the drugs. 1.16.2 Reverse Distributors A pharmacy at any (me can forward controlled substances for destruc(on to a reverse distributor, which on behalf of the pharmacy can return controlled substances to a manufacturer or dispose of them. The reverse distributor ﬁlls out a 222 Form for any schedule II substances that are being destroyed The pharmacy records the drug name, dosage form, strength, quan(ty, and date of transfer for any CIII through CV substances The reverse distributor, not the pharmacy, is responsible for comple(ng the DEA form 41 once the drugs are destroyed 1.16.3 Summary of DEA Final Rule on Disposal of Controlled Substances On September 8, 2014, the Drug Enforcement Administra(on published the Final Rule for the Disposal of Controlled Substances, which implements the Secure and Responsible Drug Disposal Act of 2010. The rule became eﬀec(ve on October 9, 2014. Prior to the passage of the Act, there were no legal provisions for pa(ents to dispose of unwanted pharmaceu(cal controlled substances except to give them to law enforcement, and pharmacies, doctors’ oﬃces, and hospitals were not allowed to accept them. The ﬁnal rule sets requirements for DEA registrants (including pharmacies) that voluntarily decide to establish disposal programs to collect unwanted controlled substances from ul(mate users. The rule allows numerous DEA registrants to become authorized to establish disposal programs including manufacturers, distributors, reverse distributors, narco(c treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies. These persons may become authorized to have disposal programs by modifying their DEA registraJons. The ﬁnal rule allows a number of disposal program op(ons including mail-back programs, collecJon receptacles, which pharmacies can par(cipate in, and collec(on events, which are authorized only for law enforcement (although any person or pharmacy may partner with law enforcement to hold a collec(on take back event). Authorized hospitals/clinics and retail pharmacies may maintain collec(on receptacles at long-term care facili(es. In addi(on, long-term care facili(es may dispose of controlled substances on behalf of an ul(mate user residing or previously residing at the facility in the collec(on receptacle maintained by the hospital/clinic or retail pharmacy. The rule requires destruc(on of collected controlled substances. It does not require a speciﬁc method but does require that the destroyed substances be rendered non-retrievable i.e. unavailable, unusable, and not capable of being transformed into a controlled substance. It also sets speciﬁc requirements for process and records for the destruc(on of collected controlled substances. The regula(ons are very detailed regarding these processes and should be read in their en(rety for a complete understanding, especially if a pharmacy is considering becoming a collector.” 1.17 Controlled Substance Theg or Loss The registrant shall noJfy the DEA Field Division Oﬃce, in wriJng, of the thef or signiﬁcant loss of any controlled substances within one business day of discovery of such loss or thef. If a subsequent inves(ga(on indicates that a thef or loss has not occurred, then the pharmacist does not need to complete DEA form 106. However, the registrant should no(fy DEA in wri(ng of this fact in order to resolve the ini(al report and explain why no DEA form 106 was ﬁled regarding the incident. When considering whether a thef or loss is signiﬁcant, the following factors should be considered: The actual quan(ty of controlled substances missing The speciﬁc controlled substance missing Whether the loss of controlled substance can be associated with access to those controlled substances by speciﬁc individuals, or whether the loss can be a\ributed to unique ac(vi(es that may take place involving those controlled substances A pa\ern of losses over a speciﬁc (me period, whether the losses appear to be random and the results of eﬀorts taken to resolve the losses If known, whether the speciﬁc controlled substances are likely candidates for thef or diversion; and Local trends and other indicators of the thef or diversion poten(al of the missing controlled substance However, assuming that there was a conﬁrmed thef or loss, the pharmacy should complete the DEA 106 form related to the thef or loss, which is available online at h\p://www.DEAdiversion.usdoj.gov under the heading DEA Forms and Applica(ons, Repor(ng Forms. The registrant must also ﬁle a complete and accurate DEA Form 106 with the Administra(on through DEA's Diversion Control Division secure network applica(on within 45 days afer discovery of the thef or loss. Some of the informa(on required on the online form includes the name and address of the pharmacy, DEA registra(on number, date of the thef or loss, if the police were no(ﬁed, the type of thef or loss, a list of the missing items taken or lost including their es(mated value, any iden(fying symbols or cost codes on the containers, and the name and (tle of the person comple(ng the report. It is also required to report any correc(ve ac(ons that may have been taken to prevent a future loss. The DEA recommends that the one business day noJﬁcaJon requirement is made by Fax. It is up to the professional judgment of the pharmacist as to what consJtutes a "signiﬁcant" loss. For example, a missing boble of 100 Phenobarbital would likely not be viewed as signiﬁcant, whereas a loss of 3 bobles of 100 of OxyconJn would be. In New Jersey, in the event of a signiﬁcant theg or loss of controlled substances, in addiJon to noJfying the DEA, a wriben report must also be ﬁled with the Board of Pharmacy, which includes a copy of the DEA 106 form. Also, the DCU needs to receive a copy of the DEA 106 form as well. 1.18 Controlled Substance PrescripJons A prescrip(on for a controlled substance must be issued for a legi(mate medical purpose by an individual prac((oner ac(ng in the usual course of his/her professional prac(ce. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing prac((oner, but a corresponding responsibility rests with the pharmacist who ﬁlls the prescrip(on. 1.18.1 RestricJons A prescrip(on may not be issued in order for an individual prac((oner to obtain controlled substances for supplying the individual prac((oner for general dispensing to pa(ents. Keep in mind that this does not mean that a prescriber cannot obtain controlled substances from you for dispensing to pa(ents, but simply that they cannot be ordered on a prescrip(on form. Typically, Schedule III through V substances would be ordered on an invoice, whereas Schedule II substances would have to be ordered on a 222 order form completed by the prescriber. A prescrip(on may not be issued for Methadone for detoxiﬁca(on or maintenance treatment. However, methadone can be dispensed in a retail pharmacy for analgesic purposes. 1.18.2 Manner of Issuance All controlled substance prescrip(ons shall be dated as of, and signed on, the day when issued and shall bear: o Full name and address of pa(ent. (If the pa(ent is an animal, the name and address of the owner and the species of the animal is required). o Drug name, strength, dosage form, quan(ty prescribed, direc(ons for use o Name, address and DEA number of prescriber o Manual signature of the physician (no signature stamps) 1.18.3 Allowable Changes to a Controlled Substance PrescripJon (Schedules III-V) The pharmacist may: Add the pa(ent’s address or change the pa(ent’s address upon veriﬁca(on. The pharmacist may change or add the dosage form, drug strength, drug quan(ty, or direc(ons for use, only aDer consulta9on with and agreement of the prescribing prac99oner. Such consulta(ons and corresponding changes should be noted on the prescrip(on as well as the pa(ent’s medical record. Pharmacists and prac((oners must comply with any state/local laws, regula(ons, or policies prohibi(ng any of these changes to controlled substance prescrip(ons. The pharmacist is never permi\ed to make changes to the pa(ent’s name, controlled substance prescribed (except for generic subs(tu(on permi\ed by state law) or the prescriber’s signature. In NJ, prescripJons cannot be wriben for any Schedule II amphetamine or sympathomimeJc amine for use in weight management or faJgue In NJ, all prescripJons for CS, regardless of schedule, shall be presented to the pharmacist within 30 days ager the date when issued. In NJ, CII CS prescrip(ons previously were limited to a maximum of a 30-day supply or 120 dosage units, whichever is less, unless the prac((oner follows a treatment plan designed to achieve eﬀec(ve pain management of a pa(ent suﬀering from cancer, intractable pain, or terminal illness. The above provision has now been changed to "a quanJty not to exceed a 30-day supply, which shall be at the lowest eﬀecJve dose as determined by the directed dosage and frequency of dosage.” Pharmacists should follow state law as to whether similar changes can be made to Schedule II prescripJons. New Jersey does allow similar changes/addiJons to Schedule II prescripJons (including adding the DEA number if missing). For reference consult the July 2014 board newsleber by clicking here. A computer-generated prescripJon for a controlled substance that is printed out or faxed by the pracJJoner must be manually signed. 1.19 Controlled Drug PrescripJon Transfer Generally permissible on a one-(me basis only. However, pharmacies electronically sharing a real (me, on-line, database may transfer up to the maximum reﬁlls allowed by law. The transfer must be communicated between two pharmacists. 1.19.1 The Transferring pharmacist must record: "VOID" on the face of the prescrip(on Name, address, and DEA of the transferee pharmacy Name of the transferee pharmacist Date the prescrip(on was transferred Pharmacist that transferred the prescrip(on 1.19.2 The Transferee pharmacist must record: "Transfer" on the face of the prescrip(on Date of issue of the original prescrip(on Original number of authorized reﬁlls Original date of dispensing Number of valid reﬁlls remaining and the dates and loca(ons of the previous reﬁlls Pharmacy name, address, DEA number, and prescrip(on number from which the prescrip(on informa(on was transferred Name of pharmacist who transferred the prescrip(on Pharmacy name, address, DEA number, and prescrip(on number from which the prescrip(on informa(on was originally ﬁlled 1.19.3 Transfer of Unﬁlled Electronic PrescripJons for IniJal ﬁlling The DEA recently implemented regula(ons in August 2023 that allow the transfer of unﬁlled electronic prescrip(ons for controlled substances for ini(al ﬁlling, upon request from the pa(ent, on a one-(me basis. This applies to all schedules, including schedule II prescrip(ons. When a CIII-V controlled substance prescrip(on is issued with authorized reﬁlls and is transferred, the authorized reﬁlls are transferred with the original prescrip(on. The prescrip(on must be transferred in its electronic form and may not be converted to another form (e.g., paper, facsimile) for transmission. The documenta(on requirements are the same as those for a non-electronic CS transfer prescrip(on. Note that in New Jersey, the term "Pharmacist" means any pharmacist licensed by the State of New Jersey to dispense controlled substances and shall include any other person (for example, a pharmacist intern authorized by the State to dispense controlled substances under the supervision of a pharmacist licensed by the State). 1.20 Retrieval and Storage of Controlled Substance Reﬁll InformaJon If using a manual system, the pharmacist must ini(al and date the back of the prescrip(on for each reﬁll. Reﬁlls are allowed on substances in Schedules III and IV a maximum of 5 Jmes or over a period of 6 months, whichever comes ﬁrst, to the extent allowed by the physician. 1.20.1 Computer requirements to be able to store controlled substance reﬁll informaJon Alterna(vely, a computer system may be used for the retrieval and storage of reﬁll informa(on, if it can provide: On-line retrieval of original prescripJon order informaJon, including original prescrip(on number, date of issuance of the original prescrip(on, full name and address of the pa(ent, name address and DEA number of the prac((oner, and the name, strength, dosage form, and qty of the controlled substance prescribed, (and qty dispensed if diﬀerent), and total number of reﬁlls authorized by the prescriber. On-line retrieval of the current reﬁll history of controlled substance prescripJon orders. The reﬁll history shall include, but is not limited to, the name of the controlled substance, the date of reﬁll, quan(ty dispensed, the iden(ﬁca(on code, or name or ini(als of the dispensing pharmacist for each reﬁll and the total number of reﬁlls dispensed to date for that prescrip(on order. DocumentaJon that any reﬁll informaJon entered in the computer is correct. If the system is capable, the pharmacist must generate a printout of each day’s controlled substance prescrip(on reﬁll data, verify, date, and sign it. The printout must be provided within 72 hours of the (me the reﬁll was dispensed. If there is no printout capability, then the pharmacist must sign a logbook or separate ﬁle each day, verifying the accuracy of the reﬁll informa(on by the pharmacist. Capability of prinJng out reﬁll informaJon (e.g. a reﬁll-by-reﬁll audit trail for any speciﬁed strength and dosage form of any controlled substance (by either brand or generic name or both). The printout must include the name of the prescribing prac((oner, name and address of the pa(ent, quan(ty dispensed on each reﬁll, date of dispensing for each reﬁll, name or iden(ﬁca(on code of the dispensing pharmacist, and the number of the original prescrip(on order. If using central record keeping to store this informa(on, must be able to provide this printout within 48 hours. Auxiliary procedure to document reﬁlls in the event of system downJme. This auxiliary procedure must ensure that reﬁlls are authorized by the original prescrip(on order; that the maximum number of reﬁlls has not been exceeded, and that all of the appropriate data is retained for on-line data entry as soon as the computer system is available. In New Jersey, there is a 5-year retenJon requirement on the controlled substance reﬁll data veriﬁcaJon, whether it is generated by a computer printout or captured in a log book. In New Jersey, schedule V prescripJons can be reﬁlled for up to a year, but the reﬁlls must be expressly authorized by the prescriber on the prescripJon. 1.20.2 AddiJonal Reﬁlls for Controlled Substance PrescripJons The prac((oner may authorize addi(onal reﬁlls of Schedule III-V through an oral reﬁll authoriza(on provided that: Total quan(ty authorized, including that on the original does not exceed ﬁve reﬁlls nor extend beyond six months from the date of issue The pharmacist ini(als and records the date, quan(ty authorized, and number of addi(onal reﬁlls authorized on the reverse of the original prescrip(on The quan(ty of each addi(onal reﬁll is equal to or less than the quan(ty authorized for the ini(al ﬁlling In New Jersey addiJonal quanJJes of controlled substances may only be authorized by a prescribing pracJJoner through the issuance of a new prescripJon which shall be a new and separate prescripJon. 1.21 InspecJons Under the CSA Before an inspec(on, the inspector is required to: State the purpose of the inspec(on Present creden(als, and Provide a wriFen No9ce of Inspec9on However, if a Search Warrant is served on the pharmacist, it cannot be refused. Normally a search warrant is issued only when a law enforcement oﬃcer convinces a judge that a crime has been or will be commi\ed and that relevant evidence exists at the site to be inspected Similarly, an Administra(ve Inspec(on Warrant cannot be refused An AIW is similar to a search warrant, but one important diﬀerence is that a judge will issue an AIW given a probable cause of serving "a valid public interest" The pharmacist has a right to refuse the inspecJon or withdraw consent at any Jme during the inspecJon when only a “NoJce of InspecJon” is served A "valid public interest" can simply be that a period of Jme has elapsed since the last inspecJon or that the pharmacy is ordering more CS than a similar pharmacy. The bobom line is that it is much easier for an inspector to obtain an AIW than a search warrant. 1.22 Mailing of Controlled Substances The United States Postal Regula(ons formerly allowed only prescrip(on medicines containing non-narco(c controlled substances to be mailed from a prac((oner or dispenser to an ul(mate user. The regula(ons have been amended to allow the mailing of narco(c controlled substances. 1.22.1 Special Requirements for Mailing o Must be placed in a plain outer mailing container or securely over-wrapped in plain paper o The inner container must also be labeled to show the prescrip(on number and the name and address of the pharmacy, prac((oner, or other person dispensing the prescrip(on o The outer mailing wrapper or container is free of markings that indicate the nature of the content 1.23 Facsimile PrescripJons Faxing of CII prescrip(ons is allowed. However, before dispensing a faxed CII prescrip(on, the pharmacist must generally receive the original signed Rx for review, except for a faxed prescrip(on for: A schedule II to be compounded for direct administra(on to a pa(ent by parenteral, intravenous, intramuscular, subcutaneous, or intra-spinal infusion A schedule II narco(c for a hospice pa(ent. The prac((oner or the prac((oner's agent will note on the prescrip(on that the pa(ent is a hospice pa(ent). Any scheduled II substance for a pa(ent in a long term care facility ” CSA regulaJons also permit faxed prescripJons for C III-V (and non-controlled substances) to serve as original prescripJons. In New Jersey, there are some subtle diﬀerences in this area. For all 3 excepJons noted in this secJon, the faxed prescripJon has to be for pain management. Also, for the faxed CII for a hospice paJent, the pracJJoner or agent needs to write on the fax that it is for a hospice paJent. 1.24 Methadone (Dolophine) Dispensing A pharmacist can dispense Methadone in a retail seong for analgesic purposes only. For addicts, treatment with Methadone is only allowed in a Methadone Clinic with the following excep9ons: Dispensing by a physician over a 3-day period while in the process of enrolling a pa(ent in a clinic. Note that this would occur in the context of the physician's oﬃce and a prescrip(on would not be issued. Administering to a pa(ent while hospitalized for a condi(on unrelated to the addic(on For intractable pain (e.g., terminal cancer pa(ent) ” Only the physician or an RN, LPN, or R.Ph or any other healthcare professional authorized by Federal and State law to administer or dispense opioid drugs operaJng under the direcJon of the physician can administer Methadone at a clinic. 1.25 Opioid Treatment Programs The Narco(c Addict Treatment Act of 1974 required prac((oners who wished to conduct maintenance or detoxiﬁca(on treatment to only register separately with the DEA as narco(c treatment programs ( NTPs). In May 2001, the treatment programs changed from being called NTP’s to Opioid Treatment Programs (OTPs) and their responsibility and oversight shifed from the FDA to SAMHSA. Opioid Treatment Programs (OTPs), otherwise known as Methadone Clinics or Programs, allow physicians to provide medica(on-assisted treatment (MAT) to those diagnosed with an opioid-use disorder under a comprehensive treatment plan. MAT combines the use of medica(on with behavioral health services to provide an individualized approach to the treatment of opioid use disorder. These programs, however, must obtain approval and cerJﬁcaJon from the Substance Abuse and Mental Health Services AdministraJon (SAMHSA), and from the state methadone authority. They must also register with the DEA as a Narco(c Treatment Program via a DEA Form 363. In addi(on, OTP’s must be accredited by an independent, SAMHSA-approved accredi(ng organiza(on. Informa(on related to the Cer(ﬁca(on of Opioid Treatment Programs is listed in 42 CFR Part 8, which also includes regula(ons for using narco(c drugs to treat opioid dependency. Methadone and levo- alpha- acetyl- methadol (LAAM) are the only schedule II drugs used in the OTP. Buprenorphine and Buprenorphine-Naloxone are schedule III drugs that are also approved for the treatment of opiate use disorder in these treatment programs. 1.25.1 Applicable DeﬁniJons The term “detoxiﬁcaJon treatment” means: the dispensing of an opioid agonist treatment medica(on in decreasing doses to an individual to alleviate adverse physiological or psychological eﬀects incident to withdrawal from the con(nuous or sustained use of an opioid drug and as a method of bringing the individual to a narco(c drug- free state within such period. There are two types of detoxiﬁca(on treatment, short-term detoxiﬁca(on treatment and long-term detoxiﬁca(on treatment: Short-term detoxiﬁca(on treatment is for a period not in excess of 30 days Long-term detoxiﬁca(on treatment is for a period more than 30 days but not in excess of 180 days The term “maintenance treatment” means: the dispensing of an opioid agonist treatment medica(on at stable dosage levels for a period in excess of 21 days, in the treatment of an individual for opioid addic(on. 1.26 Oﬃce-Based AddicJon Treatment The Drug Addic(on Treatment Act (DATA) of 2000 expanded the treatment of opiate addicts beyond the clinic, in that it allows the use of Buprenorphine (Subutex) and Buprenorphine & Naloxone (Suboxone) to be dispensed in a retail pharmacy for the treatment of opiate addic(on. Subutex is typically used for ini(al treatment and Suboxone is used for maintenance treatment. Previously, only Qualiﬁed Physicians could write prescrip(ons for Subutex or Suboxone. Qualiﬁed Physicians had to apply for a DATA waiver and were given a DEA number in addi(on to their regular DEA number. For example, if the physician’s regular DEA number weas AB 9787079, then the addi(onal DEA, which allowed prescribing of Buprenorphine, would be XB 9787079. On December 29, 2022, Congress eliminated the DATA-Waiver Program with the signing of the Consolidated Appropria(ons Act of 2023. Prescribers are no longer required to obtain a DATA waiver to treat pa(ents with buprenorphine for opioid use disorder. Accordingly, all prescrip(ons for buprenorphine now only require a standard DEA registra(on number. The previously used DATA-Waiver registra(on numbers that started with an “X” are no longer needed for any prescrip(on. Previously, a prac((oner’s DEA number and the Data Waiver registra(on number were both required on a prescrip(on for buprenorphine. Also, there are no longer any limits or pa(ent caps on the number of pa(ents a prescriber may treat for opioid use disorder with buprenorphine. This does not impact exis(ng state laws or regula(ons that may be applicable. Previously, prac((oners could only treat 30 individuals with buprenorphine for the ﬁrst year afer obtaining the DATA waiver, afer which (me they could increase the number of ac(ve pa(ents in increments determined by SAMHSA. All prac((oners who have a current DEA registra(on that includes Schedule III authority may now prescribe buprenorphine for Opioid Use Disorder in their prac(ce if permi\ed by applicable state law. Separately, the Consolidated Appropria(ons Act also introduced new one-(me training requirements for all controlled substance prescribers (except den(sts and veterinarians). Previously, as part of the DATA waiver process, a physician to have a cer(ﬁca(on in either Addic(on Medicine or Addic(on Psychiatry or complete a 8 hours of applicable CE credits. Physician Assistants and Nurse Prac((oners previously had to earn 24 hours of applicable CE to be qualiﬁed. Now, PA’s and NP’s only need to earn 8 hours of applicable CE. In addi(on, physicians, physician assistants, and nurse prac((oners can also earn the right to prescribe buprenorphine if within 5 years of applying for or renewing their DEA registra(on, they obtained 8 hours of training in the school curriculum or residency on trea(ng and managing pa(ents with opioid and other substance use disorders, including the appropriate clinical use of all drugs approved by the FDA for the treatment of a substance use disorder. Subutex and Suboxone are Schedule III Controlled Substances 1.27 Storage of Controlled Drugs Controlled drugs may be stored in a secure, substan(ally constructed locked cabinet, or may be dispersed throughout the stock in such a way as to obstruct thef or diversion. Some pharmacies make it a prac(ce to lock up Schedule II substances. Keep in mind that this a legi(mate precau(on to take, but it is not a federal or state requirement. 1.28 Emergency Kits A pharmacy may place an emergency kit with controlled substances in a non-DEA registered Long Term Care Facility (LTCF), if the appropriate state agency or regulatory authority speciﬁcally approves the placement and promulgates procedures that delineate: The source from which the LTCF may obtain controlled substances for emergency kits and that the source of supply is a DEA-registered hospital/clinic, pharmacy, or prac((oner. The security safeguards for each emergency kit stored at the LTCF, including who may have access to the emergency kit, and speciﬁc limita(on of the type and quan(ty of controlled substances permi\ed in the kit. The responsibility for proper control and accountability of the emergency kit within the LTCF, including the requirement that the LTCF and the supplying registrant maintain complete and accurate records of the controlled substances placed in the emergency kit, the disposi(on of the controlled substances, and the requirement to take and maintain periodic physical inventories. The emergency medical condiJons under which the controlled substances may be administered to LTCF paJents, including the requirement that controlled substances be administered by authorized personnel only as expressly authorized by an individual prac((oner. (i.e., through a properly executed order for the respec(ve controlled substance). The prohibited acJviJes that if violated could result in state revoca(on, denial, or suspension of the privilege to supply or possess emergency kits containing controlled substances. 1.29 Labeling Requirements for Commercial Packages of Controlled Substances Each commercial container of a controlled substance shall have printed on the label the symbol designa(ng which schedule the controlled substance is listed. The symbol shall be prominently located on the label or the labeling of the commercial container, and shall be large enough to aﬀord easy iden(ﬁca(on of the schedule of the controlled substance upon inspec(on without removal from the dispenser’s shelf. (note the more stringent requirements in New Jersey in the text box). 1.30 Sealing of Controlled Substances On each commercial container of any controlled substance, there shall be securely aﬃxed to the stopper, cap, lid, covering, or wrapper a seal to disclose upon inspec(on any tampering or opening of the container. 1.31 Verifying LegiJmacy of a DEA Number DEA numbers consist of 2 alpha characters followed by 7 digits. The second le\er corresponds to the ﬁrst le\er of the last name of the prac((oner. See the note for how the ﬁrst le\er is assigned. Add the second, fourth, and sixth digits. Then double that amount. To this subtotal, add the ﬁrst, third, and ﬁfh digits. The last digit of the total should correspond with the last digit of the DEA number. For example, for the DEA number 1234563, add the second, fourth, and sixth digit (2 +4 +6 X 2 =24) Add this sum to the total of the ﬁrst, third, and ﬁfh digits (24 + 1+3+5=33) The last digit in this total corresponds to the last digit 3 in the DEA number 1234563 Keep in mind that if you are using the formula above to check a DEA number, and the last digit in the total corresponds the last digit in the DEA number, that all you have proven is that you have a poten(ally correct DEA number. The only way to know for sure if the DEA number is legi(mate is to check the DEA database. Due to the large Type A (PracJJoner) registrant populaJon, the iniJal alpha lebers "A" and "B" have been exhausted. DEA has begun using the new alpha lebers "F" and "G" as the iniJal character for all new registraJon for Type A (PracJJoner). So now all physician DEA numbers will all begin with A, B, F, or G. Wholesaler DEA numbers begin with a P or an R, whereas mid-level pracJJoner DEA numbers begin with the leber M. 1.32 Controlled Substance PrescripJon Label The controlled substance prescrip(on label in New Jersey must contain: The pharmacy name and address The pharmacy telephone number The brand name, or if a generic, the brand name and the name of the generic in the following form, with the generic name and brand name inserted as appropriate: "--------- Generic for ---------" The strength of medica(on, where applicable The quan(ty dispensed The date upon which prescrip(on medica(on is dispensed A CDS cau(onary label The pa(ent name The prac((oner's name The prescrip(on number Direc(ons for use; and The phrase "use by" followed by the product's use by date, if dispensed in any packaging other than the manufacturer's original packaging (i.e., the earlier of one year from the date of dispensing or the expira(on date on the manufacturer's container) 1.32.1 Controlled Substance PrescripJon Label (Central Fill) For any prescrip(ons ﬁlled at a central ﬁll pharmacy, the central ﬁll pharmacy shall aﬃx a label showing: The retail pharmacy name and address, and A unique iden(ﬁer (i.e., the central ﬁll pharmacy’s DEA number indica(ng that the prescrip(on was ﬁlled at the central ﬁll pharmacy) The paJent name, the brand or generic name of the medicaJon, and the direcJons for use shall appear in larger type, in a diﬀerent color type, or in bolded type, in comparison to the other informaJon required to appear on the label. LegislaJon was recently enacted that requires pharmacists when dispensing opioids to aﬃx an auxiliary label describing the associated risks (i.e., addicJon and overdose). The Board of Pharmacy has proposed implemenJng regulaJons that the auxiliary label must read Opioid Risk of AddicJon and Overdose; Be RED or YELLOW; Be black text 10-12 Font and; Be on the same side as prescripJon label (front). Normal labeling requirements for controlled substances, including the cauJon statement, are waived for insJtuJonal paJents if: Schedule II drug is dispensed in NMT a 7 day supply, or Schedule III-V drug is dispensed in a 34 day supply or 100 unit doses, whichever is less, and the drug is not in possession of the ulJmate user prior to administraJon and other appropriate safeguards are insJtuted. 1.33 Central Filling of Controlled Substances The concept of central ﬁlling is a fairly simple one. It involves more than one pharmacy being involved in the ﬁlling of a prescrip(on. The simplest example is a pharmacy who receives a prescrip(on from a pa(ent, which is then forwarded to another pharmacy (i.e., a central ﬁll) pharmacy, which actually ﬁlls the prescrip(on and then returns it to the pharmacy that originally accepted the prescrip(on. The DEA permits this process for the ﬁlling of controlled substances if the following requirements are met. 1.33.1 Transmiong Pharmacy Requirements Prescrip(ons may be transmi\ed electronically from the retail (transmivng) pharmacy to the central ﬁll pharmacy. The transmivng pharmacy must write “central ﬁll” pharmacy on the face of the prescrip(on and record the name, address, and DEA number of the central ﬁll pharmacy; the name of transmivng pharmacist; and date of transmission. The transmivng pharmacy must also keep a record of receipt of the ﬁlled prescrip(on, including the date of receipt, method of delivery and the name of the employee accep(ng delivery. 1.33.2 Central Fill Pharmacy Requirements The central ﬁll pharmacy must keep a copy of the prescrip(on if sent by fax or an electronic record of the informa(on sent, including name, address, and DEA number of the transmivng pharmacy. The central ﬁll pharmacy must also keep a record of the date of receipt of the transmi\ed prescrip(on, the name of the pharmacist ﬁlling the prescrip(on, and the date of ﬁlling. Must also keep a record of the date delivered to the retail pharmacy and the method of delivery. 1.34 Veterinary Prescribing A veterinarian may prescribe, administer, or dispense a controlled substance, other drug or device only: In good faith in the course of his/her professional prac(ce, and Not for use by a human being Be alert for scenarios on the exam whereby a physician is abempJng to write a prescripJon for an animal or a veterinarian is abempJng to write a prescripJon for a human—neither of which is permissible. A prescripJon wriben for a controlled substance for an animal would not list the animal's name but rather the species of the animal and the name and address of the owner. 1.35 Controlled Substance RegistraJon ProtecJon Act Was enacted to protect DEA registrants such as pharmacies and mandates that a federal inves(ga(on result if any of the following occur: Replacement cost of Controlled Substances taken is $500 or greater Registrant or other person is killed or suﬀers signiﬁcant injury Interstate or foreign commerce is involved in the planning or execu(on of the crime ” 1.36 DistribuJon of Controlled Substances upon DisconJnuance of a Business 1.36.1 When not transferring the business acJvity When a registrant wishes to discon(nue a business and not transfer it to another person, the registrant must return the cer(ﬁcate of registra(on together with any unused 222 forms to the DEA at the Washington DC oﬃce. The registrant must also complete a DEA 41 Form and wait for response on how to dispose of controlled substances. 1.36.2 When transferring the business acJvity When a registrant wishes to discon(nue a business and transfer it to another person, the registrant must submit the proposal to the DEA 14 days in advance and include: Name, address, and DEA number of the registrant discon(nuing the business and well as the same informa(on for the registrant acquiring the business Whether the business ac(vi(es will con(nue at the current loca(on or at another loca(on Unless the DEA says no, the transfer can occur, and on the day of the transfer, a complete controlled substance inventory must be taken (transfer of CIIs must be done through the use of the 222 Form). The controlled substance records are also transferred. Penal(es Upon Convic(on: Burglary or robbery - a maximum $25,000 ﬁne and/or 20 years imprisonment. If a dangerous weapon was used to carry out the crime - a maximum $35,000 ﬁne and/or 25 years imprisonment. If death resulted from the crime - a maximum $50,000 ﬁne and/or life imprisonment. Examples of interstate commerce would be if a robbery was planned in New Jersey for example, and carried out in Pennsylvania, or if a robbery was carried out in Pennsylvania and the perpetrators ﬂed across state lines to New Jersey. In New Jersey, the state cer(ﬁcate of registra(on get returned to the DCUwithin 10 days. You must also similarly no(fy the DCU of proposed transfer date 14 days prior along with the name, address, State CDS and Federal DEA # of transferor and transferee (same requirements apply for any registrant receiving Rx ﬁles). Also, must report the name & address of the person or ﬁrm who will maintain invoices, & executed order forms of the discon(nued business for period not less than 2 years.” 1.37 Miscellaneous Controlled Substance ConsideraJons No DEA registrant may employ an individual who has access to controlled substances if that individual had previously been convicted of a felony oﬀense related to controlled substances or, who at any (me, had an applica(on for CS registra(on denied, revoked, or surrendered for cause. Individuals who ﬁnd themselves in this situa(on do have the op(on of reques(ng a waiver from the DEA from this prohibi(on A state law or regula(on can be stricter than its federal counterpart as long as it doesn’t conﬂict 1.38 Combat Methamphetamine Epidemic Act On March 9, 2006, President Bush signed into law the Combat Methamphetamine Epidemic Act. Listed below is a summary of the key requirements governing the retail sale of all cough and cold products that contain the methamphetamine precursor chemicals ephedrine, pseudoephedrine or phenylpropanolamine, collec(vely referred to Scheduled Listed Chemical Products (SLCP's). For all intents and purposes, phenylpropanolamine has been withdrawn from the market and is no longer at issue. 1.38.1 Sales limits Daily Sales Limit on Retailers: Retail sales may not exceed 3.6 grams (base) per day per purchaser, regardless of the number of transac(ons. 30-Day Purchase Limit on Consumers: Individuals are prohibited from purchasing more than 9 g (base) per 30- day period. Mail Order Limits: Mail order companies may not sell more than 7.5 grams (base) to a customer within a 30-day period. Mail order sales are not subject to the logbook, training or cer(ﬁca(on requirements listed below, although the seller does need to obtain iden(ﬁca(on as required below. 1.38.2 Other RestricJons - Behind-the-Counter Placement: All SLCP products must be placed behind a counter that is not accessible to purchasing consumers or in a locked display case that is located on the selling ﬂoor. - Logbook: Retailers must maintain a wri\en or electronic logbook of informa(on on transac(ons involving SLCP products. The logbook may be maintained in either wri\en or electronic form. The purchaser signs the logbook and enter name, address, and date/(me of sale. Obviously, some retailers capture the name, address, and date/(me of sale automa(cally with a card swipe. The retailer then checks the informa(on entered by purchaser against photo ID and enters the name of product sold and quan(ty. Logbook requirements do not apply to purchases of single sales packages that contain no more than 60 mg of pseudoephedrine. - False Statements NoJce: The wri\en or electronic logbook must also include the following no(ce: WARNING: Sec(on 1001 of Title 18, United States Code, states that whoever, with respect to the logbook, knowingly and willfully falsiﬁes, conceals, or covers up by any trick, scheme, or device a material fact, or makes any materially false, ﬁc((ous, or fraudulent statement or representa(on, or makes or uses any false wri(ng or document knowing the same to contain any materially false, ﬁc((ous, or fraudulent statement or entry, shall be ﬁned not more than $250,000 if an individual or $500,000 if an organiza(on, imprisoned not more than ﬁve years, or both. - 2-Year RetenJon Period: Each entry must be maintained for two (2) years following the date of entry. - Photo ID: In conjunc(on with the logbook requirement, retailers will be required to ask for photo iden(ﬁca(on, issued by either a State or the Federal Government or other appropriate iden(ﬁca(on. For a list of alternate forms of iden(ﬁca(on acceptable under 8 C.F.R. §§ 274a.2(b)(1)(v)(A) and 274a.2(b)(1)(v)(B). You may be surprised to note that even a report card is listed as one of the acceptable alterna(ve forms of iden(ﬁca(on. 1.38.3 Training and Employees - Training & CerJﬁcaJon: Retailers must train applicable sales personnel to ensure that they understand the requirements of SLCP product sales and submit self-cer(ﬁca(ons to the A\orney General in this regard. The self cer(ﬁca(on must be updated on an annual basis. Retailers must also maintain cer(ﬁca(ons and records to conﬁrm employee training. - Consequences: The A\orney General may prohibit persons who sell products in viola(on of the sales restric(ons or the logbook, training, and cer(ﬁca(on requirements from selling any scheduled listed chemical products. - Job Applicant Screening: Retail stores may take reasonable measures to guard against employing individuals who may present a risk with respect to the thef and diversion of SLCP products, including asking job applicants whether they have been convicted of any crime involving or related to SLCP products or controlled substances. Remember to calculate the allowable quan((es based on the amount of BASE in the product: For example, in a 25 mg Ephedrine HCl tablet there is 20.57 mg. of base; Similarly, there is 24.65 mg of base in a 30 mg Pseudoephedrine HCl tablet; and there is 23.22mg of base in a 30 mg Pseudoephedrine SO4 tablet. A good rule of thumb to remember is that you can purchase 146 tablets per day of Sudafed 30mg (Pseudoephedrine HCL). How do you know this? Well, if someone can purchase 3.6 gms of base/day, that would be 3,600 mg. But you should not divide this by 30 mg and get 120 tablets as a maximum/day quan(ty. You need to divide 3,600 mg by 24.65 (i.e. the amount of base/tablet) and the result is 146 tablets. Note that under federal law there is no speciﬁc age requirement to purchase an SLCP product, although NJ imposes an age requirement of 18 years to purchase. Any loss or disappearance of a scheduled listed chemical product (e.g. Sudafed) must be reported to the DEA orally ASAP, and then followed up with a wri\en report within 15 days. In NJ you are also required to report to local law enforcement the loss of 30 grams or more of products where the SLCP is the sole ac(ve ingredient. 1.39 Issuance of MulJple PrescripJons for Schedule II Controlled Substances An individual prac((oner may issue mulJple prescripJons authorizing the pa(ent to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following condi(ons are met: - Each separate prescrip(on is issued for a legi(mate medical purpose by an individual prac((oner ac(ng in the usual course of professional prac(ce; - The individual prac((oner provides wri\en instruc(ons on each prescrip(on (other than the ﬁrst prescrip(on, if the prescribing prac((oner intends for that prescrip(on to be ﬁlled immediately) indica(ng the earliest date on which a pharmacy may ﬁll each prescrip(on; (e.g., Do not ﬁll un(l...) - The individual prac((oner concludes that providing the pa(ent with mul(ple prescrip(ons in this manner does not create an undue risk of diversion or abuse; - The issuance of mul(ple prescrip(ons as described in this sec(on is permissible under the applicable state laws; and - The individual prac((oner complies fully with all other applicable requirements under the Act and these regula(ons as well as any addi(onal requirements under state law. “The statutory authority to issue such prescrip(ons, however, applies only to physicians. All other prescribers in NJ, including advance prac(ce nurses and physician assistants, are precluded from issuing mul(ple Schedule II prescrip(ons to a pa(ent for a 90-day supply. Keep in mind that in New Jersey, controlled substance prescrip(ons must normally be presented for ﬁlling within 30 days and are limited to a 30 days supply. NJ law and regula(ons have been modiﬁed to allow the 90 days supply via mul(ple prescrip(ons. However, they s(ll need to be ﬁlled within 30 days of when they are allowed to be ﬁlled. New Jersey also limit is the number of mul(ple prescrip(ons to 3 (i.e., one Rx for an immediate 30-day supply and 2 addi(onal Rx's for the subsequent 2 months). 1.41 Agents of the Prescriber The DEA recently announced a policy whereby a prescriber may authorize a nonemployee agent to transmit a prescrip(on for a controlled substance to a pharmacist. Tradi(onally, nurses and other employees working in a LTCF had been transmivng physician orders to pharmacies, and the DEA took a hard line stance on this prac(ce since these individuals were not authorized agents of the physician. The newly announced DEA policy relaxes this hard line stance and creates a vehicle (i.e., wri\en agent agreement) for individuals ac(ng outside of an employer/employee rela(onship to be considered agents of the prescriber. The DEA provides a sample agent agreement in the Federal Register (Volume 75; No. 193; October 6, 2010; 61613). You can view a copy by clicking here. According to the policy, following is a list of ac(vi(es in which an authorized agent of the prescriber may engage: - Prepare a controlled substance prescrip(on for the signature of the prescriber - Orally communicate a prescriber's C-III, C-IV, or C-V prescrip(on to a pharmacist or via prac((oner-signed fax - Transmit by fax a prescriber's wri\en C-II prescrip(on to a pharmacist for a pa(ent in hospice or LTCF Emergency oral communicaJon of C-II prescripJon may not be delegated to an authorized agent DEA recommends that the original signed agency agreement be kept by the prac((oner during the term of the agency rela(onship and for a reasonable period afer termina(on or revoca(on. A signed copy should also be provided to the prac((oner's designated agent, the agent's employer (if other than the prac((oner), and any pharmacies that regularly receive communica(ons from the agent pursuant to the agreement. 1.42 CV Retail Sales Some schedule V substances may be sold OTC, if they are not a prescrip(on by federal law and permi\ed by state law, if: - The sale is done by a pharmacist - The purchaser must be at least 18 yrs. of age and must either be known to the pharmacist or have suitable iden(ﬁca(on - No more than 8 ounces or 48 dosage units of any substance containing Opium in any 48 hr period may be provided to the purchaser - No more than 4 ounces or 24 dosage units of any other controlled substance may be provided to the purchaser in any 48-hour period. - The name and address of the buyer, the name and quan(ty of the item, the date, and the signature or the ini(als of the pharmacist are recorded in a bound record book NJ also permits retail CV sales to be made by the pharmacy intern under the supervision of the pharmacist. Under federal law, the record book must be maintained for 2 years; New Jersey law requires that the CV record book be maintained for 5 years. CV OTC sales are discussed in more detail in the Drug Dispensing and PrescripJon Records secJon. That secJon describes the requirements for when an individual is making mulJple purchases, and you should be very familiar with those requirements for purposes of the MPJE exam. 1.43 PrescripJon Monitoring Program The NJ Prescrip(on Monitoring Program (PMP) is a statewide database that collects prescrip(on data on Controlled Dangerous Substances (CDS), Gabapen(n and Human Growth Hormone (HGH) dispensed in pharmacies in New Jersey, and by out-of-state pharmacies dispensing into New Jersey. Pharmacists are required to report CS prescrip(on informa(on daily, or no more than one business day afer a CS was dispensed. If the pharmacist has a reasonable belief that the person may be seeking a CDS for any purpose other than the treatment of an exis(ng medical condi(on, such as for purposes of misuse, abuse, or diversion, a pharmacist must not dispense a Schedule II controlled dangerous substance, any opioid, or a benzodiazepine drug that is a Schedule III or Schedule IV controlled dangerous substance to any person without ﬁrst accessing the prescrip(on monitoring informa(on to determine if the person has received other prescrip(ons that indicate misuse, abuse, or diversion. 1.43.1 Access by Prescribers and Pharmacists Access to the NJPMP is granted to prescribers and pharmacists who are licensed by the State of NJ and in good standing with their respec(ve licensing boards. Before issuing a prescrip(on or dispensing a prescribed drug, qualiﬁed prescribers and pharmacists who have registered to use the NJPMP are able to access the NJPMP website and request the CDS, Gabapen(n, and HGH prescrip(on history of the pa(ent. The pharmacist must cer(fy that the request is for the purpose of providing health care to or verifying informa(on with respect to a new or current pa(ent, or verifying informa(on with respect to a prescriber. Pa(ent informa(on in the NJPMP is intended to supplement an evalua(on of a pa(ent, conﬁrm a pa(ent’s drug history, or document compliance with a therapeu(c regimen. When prescribers or pharmacists iden(fy a pa(ent as poten(ally having an issue of concern regarding drug use, they are encouraged to help the pa(ent locate assistance and take any other ac(on the prescriber or pharmacist deems appropriate. 1.43.2 PaJent Privacy The New Jersey Division of Consumer Aﬀairs and its private contractor that operates the database keep NJPMP pa(ent informa(on strictly conﬁden(al, in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Rules. A prescriber or pharmacist who accesses or discloses NJPMP informa(on for any purpose other than providing healthcare to a pa(ent or verifying the NJPMP’s record of prescrip(ons issued by the prescriber, or who allows any other individuals to access the NJPMP using the prescriber’s or pharmacist’s own access codes, is subject to civil penal(es of up to $10,000 for each oﬀense and disciplinary ac(on by the prescriber’s or pharmacist’s professional licensing board. The rules related to the prescripJon monitoring program also apply to out of state pharmacies that are registered with the State Board of New Jersey. The PMP reporJng requirements do not apply to any controlled substa

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