3 -Federal controlled substance act Pg 47- OTPS 79

224

Applications For Registration/Security Requirements (pg 50) Prof C said to know the form #s. Form ______ for new registration and form ______a for renewal ("A"= renewal, no "A" = new registration) Procedure for _______ (a) Fill out application (b) Investigation - usually agency checks with state (c) Issuance of certificate of registration (d) Must be kept; need not be displayed.

1. locked, cabinet 2. Disperse 3. denied, revoked, suspended 4. immediately 5. 106

Applications For Registration/Security Requirements (pg 50) Prof C said to know the form #s. Security Requirements for CDS (21 CFR 1301.71). (1) All CDS must be stored in "a securely ________, substantially constructed _________." (21 CFR 1301.75(b)); (2) Alternative for Pharmacies and Hospitals - they may ___________ the CDS among the non-CDS in such a manner as to obstruct theft (21 CFR 1301.75(b)); **Very important**(3) Personal-Registered practitioner may not employ a person whose registration has been ______ or ______ or __________ if that person would have access to CDS stock. The regs also suggest screening questions for employees (21 CFR 1301.90); (4) Miscellaneous-The registrant shall notify the Field Division Office of the Administration in his/her area of any theft or any significant loss of CDS ____________upon discovery of such theft or loss. (21 CFR § 1301.74(c)) Note: "Regarding the timing of initial theft or loss reports, DEA inserted the word "_________" before the phrase "upon discovery." While DEA form _______(5) is not _________(4) necessary if the registrant needs time to investigate the facts surrounding a theft or significant loss, he or she should provide, in writing, initial notification of the event. This notification may be a short statement provided by fax. DEA notes that faxing is not the only method a registrant may use, but that the notification should be in writing. If the investigation of a theft or significant loss lasts longer than two months, registrants should provide updates to the DEA. To help registrants determine whether or not a loss is "significant," the DEA has added to the rule a list of factors to be considered. DEA recognizes that no single objective standard can be applied to all registrants - what constitutes a significant loss for one registrant may be construed as comparatively insignificant for another. If a registrant is in doubt as to whether or not the loss is significant, DEA advises registrant to err on the side of caution in alerting the appropriate law enforcement authorities.

1. closed 2. DEA

Federal Controlled Substance Act **Heavily tested** _________(1) SYSTEM: Act establishes a "_________(1) system" or "controlled system" for the distribution of scheduled drugs and other substances of abuse. a. CS may only be distributed between persons registered with DEA (except ultimate user) - includes manufacturers, distributors/wholesalers and dispensers (including physicians). b. Goal: Prevent drug diversion through a system of accountability. 2. PRINCIPAL LAW CSA is the Principal Federal Law regulating the manufacture, distribution, dispensing and delivery of drugs or substances which are subject to or have the potential for abuse or physical or psychological dependence. 3. _______(2)- ADMINISTERS/ENFORCES THE CSA a. Agency of the USDOJ b. Administers (enforces CSA in conjunction with FDA) c. GOAL - prevent unlawful distribution and use of CDS. (1) Normal law enforcement activities: (a) Investigations. (b) Arrest of persons engaged in unlawful distribution and abuse of CDS. (2) Regulatory Registration and control of persons legitimately engaged in handling/distribution of CDS (a) _____(1) system. (b) Registration, submission of forms (of everyone involved in chain of distribution)

in-transit

Pg 50 Security Requirements for CDS Regarding "___-_______ losses of controlled substance," DEA intends that all ___-________ losses be reported, not just significant losses. (New Jersey Board of Pharmacy Newsletter, October 2005)

1. high 2. accepted 3. safety 4. dependance 5. codeine

Pg 51/52: Schedules of CDS Purple book #171-172 SCHEDULE I (CI) (21 USCA 812(1)) a. ________(1) potential for abuse. b. No currently ________(2) medical use in treatment in U.S.. (except marijuana) c. Lack of _______(2) ________(3) for use. d. Heroin (Diacetyl morphine); marijuana, LSD (Lysergic acid diethylamide) , mescaline - controversy. Purple book #172-174 SCHEDULE II (CII) (21 USCA 812(2)) a. _______(1) potential for abuse. b. Has a currently _______(2) medical use in treatment in U.S.. c. Abuse may lead to severe psychologic or physical ___________(4). d. Opium, methadone, morphine, codeine, Oxycodone, meperidine and most amphetamines and many barbiturates. Purple book #177-178 SCHEDULE III (CIII) (21 USCA 812(3)) a. Potential for abuse less than CI and CII. b. Has currently ________(2) use. c. Abuse may lead to moderate or low physical _________(4) or _______(1) psychologic ________(4) . d. Steroids, amphetamines, Tylenol with ________(5), Suboxone Not more than 1.8 g codeine per 100 mL or not more than 90 mg per dosage unit with one or more active non-narcotic ingredient. SCHEDULE IV (CIV) (21 USCA 812(4)) a. Low potential for above relative to CIII. b. Has currently _________(2) medical use. c. Abuse may lead to limited physical _________(4) or psychological __________(4) relative to CIII. d. Valium, phenobarbital, tramadol (moved to CIV August 2014). SCHEDULE V (CV) (21 USCA 812(5)) a. Low potential for above relative to CIV. b. Currently _________(2) medical use. c. Abuse may lead to limited physical or psychological _________(4). d. Antitussive preparations with ________(5), etc.

1. 222 2. serially 3. registrant's 4. Controlled substance ordering system 5. two years

Pg 52/53: Obtaining Controlled Substances 1. CII a. Order form (1) Triplicate form (DEA #________(1)) (See page A180). (2) Numbered ______(2)(account for them). (3) Issued with ___________(3) name, address, registration number and schedules authorized to handle. (4) Issued in batches of 7 or 14 forms, depending upon activity of user. b. Electronic Order Forms (also approved in NJ) - _______ ________ ________ ________ (CSOS) (4) Requirement for Electronic Order Forms (21 CFR §1305.21) (a) To be valid, the purchaser must sign an electronic order for a Schedule I or II controlled substance with a digital signature issued to the purchaser, or the purchaser's agent by DEA. (b) The following data fields must be included on an electronic order for Schedule I and II controlled substances: (1) A unique number the purchaser assigns to track the order. The number must be in the following 9-character format; the last two digits of the year, X, and 6 characters as selected by the purchaser. (2-9) Same as hard copy. (d) An electronic order may include controlled substances that are not in schedules I and II and non-controlled substances. Procedure for Filling Electronic Orders (21 CFR §1305.22) (a) A purchaser must submit the order to a specific supplier. Unaccepted and Defective Electronic Orders (21 CFR §1305.25) (a) No electronic order may be filled if: (1) The required data fields have not been completed. (2) The order is not signed using a digital certificate issued by DEA. (3) The digital certificate used had expired or had been resolved prior to signature. (4) The purchaser's public key will not validate the digital signature. Lost Electronic Orders (21 CFR §1305.26) (a) If a purchaser determines that an unfilled electronic order has been lost before or after receipt, the purchaser must provide, to the supplier, a signed statement containing the unique tracking number and date of the lost order and stating that the goods covered by the first order were not received through loss of that order. Preservation of Electronic Orders (21 CFR §1305.27) (a) A purchaser must, for each order filled retain the original signed order and all linked records for that order for ______ ______(5). The purchaser must also retain all copies of each unaccepted or defective order and each linked statement.

1. power of attorney 2. two 3. electronically 4. predetermined 5. reasonable 6. 60 7. six 8. invoice 9. 5

Pg 54/55 Obtaining Controlled Substances g. Amended effective date October 30,3019 (Old method allowed for a two-year transition period (Oct. 30, 2021)) 1. Added to the ______ ____ ________(1) d. ______ ____ ________(1) must be issued as follows: 1) the registrant, if an individual; a partner of the registrant, if a partnership; or an officer of the registrant, if a corporation, corporate division, association, trust of other entity; 2) the person to whom the ______ ____ ________(1) is being granted; and 3). _____(2) witnesses to the signature f. may be signed ________(3) 2. Procedure for obtaining DEA forms 222 a) Issued in mailing envelopes containing a ________(4) number for forms consisting of a single sheet based on activity. A limit will be set and can only be exceeded if a request shows a _________(5) need. 3. Procedure for executing DEA forms 222 a) A computer printer has been added to the list in c(1) above 4. Procedure for filling DEA forms 222 a)Purchaser must make a copy of the original form and submit the original to the supplier. The copy may be in paper or electronic form b) Supplier may fill the order and must record on the original 222 its DEA registration number and the number of full containers furnished and the date shipped. If order cannot be filled completely it may be completed in ____(6) days. No order is valid more than ____(6)days from execution -Exception ____(6)day rule: registered procurement officers of the Defense Supply Center of logistics Agency for delivery to armed services establishments in the U.S. cannot exceed ______(7) months. (Licence exam, remember this exception!) May be shipped to locations other than the location printed on form 222. d) Supplier must retain the original form 222. If not required to report to the automation of reports and consolidated order system (ARCOS) must submit a copy of form 222 by mail or email to the DEA by the close of the month which the order is filled or if partial shipment, the close of the month of the final shipment 5. Procedure for entering DEA forms 222 a) If supplier cannot fill an order in the time limits it may be endorsed to another supplier for filling. Must state on the form the DEA number of the second supplier and be signed and dated by the authorized person of the first supplier 6. Unaccepted and defective DEA forms 222 (b) if a 222 cannot be filled the original must be returned to the purchaser with a statement as to the reason (d) if purchaser receives a 222 back he must retain it in his file for 2 years. if it is defective it may not be corrected 7. Lost and Stolen DEA forms 222 a) If unfilled 222 is lost purchaser must execute another 222 and attach a statement containing the form number, the date of the lost form and a statement of the loss. Must send this to the supplier with the new 222. d) If 222 forms are lost or the order form number is not available the approximate date of issue must be reported 8. Preservation of DEA forms 222 a) purchaser must maintain copy for 2 years b) the supplier must maintain the original for 2 years c) DEA forms 222 must be maintained separately. If more than one location they must be kept at the registered location printed on the form 222 e) Electronic copies of form 222 are deemed to be maintained separately if they are readily retrievable. They may also be kept at a non-registered location if they are readily retrievable at the registered location. 9. Return of unused DEA Forms 222. If registration of purchaser terminates for any reason, unused 222s must be returned to the DEA. (Send certified mail or w/tracking so you can prove they got it, Prof C) 2. CIII, CIV, CV a. Exempt from federal order form procedure (21 CFR 1305.3). b. Controlled through general record - keeping regulations. c. Records include invoices and packing slips (must file and keep). d. If sell to physician (must be registered) must use _______(8). Can not exceed ___(9) percent of total dosage units of CDS sold in one year.

1. dispense 2. individual practitioner 3. institutional practitioner

Pg 55 Records Definitions a. "_________(1)" in CDS context means to deliver a CDS to an ultimate user. i.e. -physician ______s(1)when: (1) Writes a Rx for a CDS. (2) Actually _________s(1) drug to patient. (3) Administers drug. Pharmacists _______(1) when they fill the Rx and give it to the patient. b. "_________ ___________(2)" (person not institution) means a physician, dentist, veterinarian, and other recognized licensees. See New Jersey Law section. Does not include a pharmacist or pharmacy. c. "__________ __________(3)" means institution registered to dispense (cannot prescribe) - hospital, clinic d. "Pharmacist" means any pharmacist licensed by a State to dispense CDS.

1. 2 2. 10 3. central

Pg 55. Records Records Maintained By Pharmacy a. Generally, must be on-site and kept for _____(1) years. (Medicare can go back ___(2) years for audits). b. _________(3) record keeping Must have permission from local DEA office - registrant must agree to deliver records to site within two business days following a written DEA request or be available for inspection by DEA at central location without warrant.

1. federal order forms 2. invoices 3. separate

Pg 56 Records Records of Acquisition a. Include: (1) Executed and completed _____ ______ _______(1) for CII's. (2) ________(2) for CIII, IV and V. b. Must be kept in "readily retrievable form" (1) CII's __________(3) from CIII - CV. (2) Controlled orders on __________(2) highlighted/underlined in red.

1. 3- drawer method 2. 2-drawer method 3. C 4. CV 5. 18 6. 48 7. 5 8. 2002 9. 200 mg codeine per 100 mL

Pg 56/57 Records Records of Disposition a. Prescriptions (1) CII: (a) Separate, or (b) With CIII-V. (c) Cancel them (not in regs.), cross out, date, sign, and write "canceled". (2) CIII - CV (a) Red letter "C" in lower right corner no less than 1" high if kept with other Rx's or with CII's. Waived if identifiable on computer. (b) Either maintained separately or with other Rx's in readily retrievable form (21 CFR 1304.04(h)). b. Inventory (beginning inventory and acquisitions) - (substances dispensed, returned and distributed) = present inventory c. DEA Form 222 used to return CDS to supplier and dispensing to registered physician. d. DEA Form 106 used for theft, loss, casualty. e. Approved filing methods 3 alternatives (1) ___-______ ________(1) (a) CII in one file area (b) CIII - CV (c) All other Rx (2) ___-________ _______(2) (a) CII - CV (CII cancelled. CIII - CV have red "____(3)" in lower right corner no less than 1" high). (b) All other Rx (3) ____-_______ ______(2) (a) CII (b) CIII - CV (have red "____(3)") with all other Rx's. Note: Red "____(3)" can be waived if the pharmacy has a qualified computer. f. "Exempt Narcotic" Record Book (21 CFR 1306.26) (OTC ____(4)) (1) Restrictions for sale: (a) Sale by RPh only. (b) Purchaser > ____(5) years old - either known to RPh or has suitable identification. (2) Limits: (a) Opium, not > 8 oz. (240 cc) or 48 dosage units of any substance containing opium in any 48 hour period. (See important note, line 5, below) (b) Other CS such as codeine, no > 4 oz. (120 cc) or 24 dosage units of any other nonprescription CS in any ____(6) hour period (3) Record sales in bound book including: (a) Name and address of purchaser; (b) Name and quantity substance; (c) Date purchase; (d) Name/initials dispensing RPh; (e) Retained for 2 years (21 C.F.R. 1304.04) (NJ - ___(7) years). (4) See N.J. rules on frequency of purchase (N.J.A.C. 13:39-7.15). #7546579.1 43 LICENSURE EXAM (5) Both paregoric and opium tincture are controlled substances. Paregoric, aka Camphorated Tincture of Opium (0.4 mg morphine per mL), is C-III. The more concentrated Opium Tincture (10 mg morphine per mL) is C-II. (21 USC 812; 21 CFR 1308) Prior to _______(8), 21 CFR 329.20 allowed preparations containing not more than a quarter grain of morphine per fluid ounce (equivalent to 54.8 mg / 100 mL) to be dispensed without a prescription provided that they contain nonnarcotic active ingredients in sufficient proportion to confer valuable medicinal qualities other than those possessed by the narcotic drug alone. Paregoric contains 40 mg morphine per 100 mL, so it was a legal OTC product until _______(8). This was repealed in _______(8)(65 FR 21783, and 67 FR 4904), and simultaneously replaced by 21 CFR 290 which states that schedules II through V are prescription only with the sole exception of preparations containing not more than _____ ____ ____ ________ ____ ______ _____(9) that also include one or more nonnarcotic active medicinal ingredients. Note: While not specifically mentioning paregoric, the comment to these changes indicated the confusion in this area needed to be addressed (65 FR 21378 4/21/2000).

V

Pg 60. PRESCRIPTIONS FOR CONTROLLED DANGEROUS SUBSTANCES DISPENSING SCHEDULE _____ a. If OTC see E. 5. f. above b. If Rx same requirement as CIII - CIV above. Appears to be no limit to number or duration of refills (21 CFR 1306.22)

1. name 2. address 3. serial 4. CII

Pg 60/61 PRESCRIPTIONS FOR CONTROLLED DANGEROUS SUBSTANCES LABELING REQUIREMENTS - ALL CII - CIV and CV (21 C.F.R. 1306.14(a and b) and 1306.24(a and b) (See N.J.S.A. 24:21-17 for New Jersey Specific Rule) The label must contain the following: a. Pharmacy ____(1) and ____(2) (If the prescription is filled at a central fill pharmacy they must affix to the package a label showing the retail pharmacy name and address and a unique identifier. [the central fill pharmacy's DEA number] indicating the prescription was filled at a central fill pharmacy); b. ______(3) number; c. Date of filling if _____(4); d. Date of filling initially and date of last refill if CIII, CIV, CV; e. Name of patient; f. Name of practitioner; g. Directions for use (sig); #7546579.1 46 h. Cautionary statements, if any. i. Above does not apply for CII rx prescribed for admin to the ultimate user who is institutionalized: Provided, that: (1) Not more than a 7-day supply at one time; (2) CDS not in possession of the ultimate user prior to administration; (3) appropriate records are kept j. Above does not apply for CIII-CV rx prescribed for admin to the ultimate user who is institutionalized: Provided, that: (1) Not more than a 3-4 day supply or 100 dosage units, which ever is less (2) CDS not in possession of the ultimate user prior to administration; (3) appropriate records are kept

1. federal 2. prohibts 3. transfer 4. other 5. NJ

Pg 61 PRESCRIPTIONS FOR CONTROLLED DANGEROUS SUBSTANCES LEGEND - CII, CIII, CIV, CV "Caution: ___(1) law _______(2) the ______(3) of this drug to any person _______(4) than the person for whom it was prescribed." TRANSFERS OF CIII - CIV (21 CFR § 1306.25) See ___(5) rules N.J.A.C. 8:65-7.14 (h). Regulated by the state law

1. non-retrievable 2. reverse 3. special agent 4. 41

Pg 61/62 Pg 61 PRESCRIPTIONS FOR CONTROLLED DANGEROUS SUBSTANCES Disposing of Controlled Substances a. Any registered practitioner can dispose lawfully obtained CDS 1. promptly destroy CDS by rendering the CDS ____-_______(1) on site 2. deliver CDS to a _______(2) distributor's registered location 3. request assistance from the _______ __________(3) as per b-d below b. Any person in possession of any controlled substance and desiring or required to dispose of such substance may request assistance from the _______ __________(3) in Charge of the Administration in the area in which the person is located for authority and instructions to dispose of such substance. The request should be made as follows: (1) If the person is a registrant, he/she shall list the controlled substance or substances which he/she desires of on DEA Form _____(4), and submit three copies of that form to the _______ __________(3)in Charge in his/her area. c. The _______ __________(3) in Charge shall authorize and instruct the applicant to dispose of the controlled substance in one of the following manners: (1) By transfer to person registered under the Act and authorized to possess the substance; (2) By delivery to an agent of the Administration or to the nearest office of the Administration; (3) By destruction in the presence of an agent of the Administration or other authorized person; or (4) By such other means as the Special Agent in Charge may determine to assure that the substance does not become available to unauthorized person. c. In the event that a registrant is required regularly to dispose of controlled substances, the _______ __________(3) in Charge may authorize the registrant to dispose of such substances in accordance with paragraph (b) of this section, without prior approval of the Administration in each instance, on the condition that the registrant keep records of such disposals and file periodic reports. d. This section shall not be construed as affecting or altering in any way the disposal of controlled substances through procedures provided in laws and regulations adopted by any State.

1. registrants 2. labeled 3. securely 4. plain

Pg 62 PRESCRIPTIONS FOR CONTROLLED DANGEROUS SUBSTANCES MAILING CONTROLLED SUBSTANCES a. Between ________(1) (US Mail): US Postal Service regulations allow mailing of CDS between ___________(1) or those exempt (patients) from registration. Inner container must be properly ________(2) and _____(3) sealed and placed in a _____(4) outer container or overwrapped in _______(4) paper with no markings indicating the contents of the package. b. Between dispenser and patient (US Mail) (21 USC 801 and US Post Office Domestic Mail Manual C020 (GO11): (1) A controlled substance is any anabolic steroid, narcotic, hallucinogenic, stimulant or depressant drug in Schedules I through V of the "Controlled Substances Act". (2) If distribution of a CS is lawful under 21 USC 801 et. seq. and any implementing regulations the USPS considers distribution by mail acceptable subject to the following standards: (a) The inner container is marked and sealed under the applicable provisions of the "Controlled Substances Act" and placed in a plain outer container or securely overwrapped in plain paper. (b) If the mailing includes prescription drugs containing a CS, the inner container is also labeled to show the prescription number and the name and address of the pharmacy, practitioner, or other person dispensing the prescription. (c) The outer wrapper or container is free of markings that would indicate the nature of the contents. #7546579.1 47 (3) After reviewing the above, Lucius A Bowser, Supervising Investigator of the N.J. Division of Consumer Affairs, Enforcement Bureau, Drug Control in a March 8, 1996 memorandum stated: "Thus there is no references to distribution (mail) to patient's families. Thus it appears that 'anything goes.'" c. U.S. Postal Services regulations do not apply to commercial shipper (i.e., Fed Ex, UPS) but follow above anyway.

1. methadone 2. DEA 3. indication 4. Drug Addiction Treatment Act of 2000 5. waiver 6. Subutex 7. Suboxone 8. X 9. Substance Abuse and Mental Health Services Administration 10. good faith

Pg 62/63 PRESCRIPTIONS FOR CONTROLLED DANGEROUS SUBSTANCES CONTROLLED SUBSTANCES FOR DETOXIFICATION a. _____________(1)(CII) (1) Initially used for detoxification/ maintenance treatment and now also used for pain management. (2) Detoxification prescribers must have a registered _______(2) number and there are complicated rules to dispense for narcotic dependence treatment. (21 CFR §1306.07) (3) An _________(3) (for example, chronic pain) may be added to the written prescription and thus it may be dispensed. (State laws vary regarding this requirement) In NJ must be written on Rx and if not must call MD and document on the Rx. b. ____ ______ ______ _______ ___ _____(4) (DATA 2000) (1) A ________(5) is granted to qualified prescribers in order to treat opiod-addiction with certain FDA approved CIII, IV, and V narcotics. (2) Examples include: _________(6) and ______(7). (3) Prescribers must meet special requirements in order to qualify for a _______(5). (4) Pharmacists must verify that the prescriber has been granted a ______(5) in order to prescribe. (5) Means of verifications include: (a) Prescribers granted a ________(5) are issued special ____(2) numbers beginning with "____(8)", which is required on all prescriptions. (b) Check the ______ ____ _____ _____ ______ _______ _______ (SAMHSA): i. www.buprenorphine.samhsa.gov (Buprenorphine Pharmacy Lookup --Practitioner last name and DEA number) ii. 1-866-287-2728 (c) Call prescriber and ask for DEA registration certificate to be faxed. NOTE: When verifying a prescriber's ______(5_ , it is a violation to disclose patient identity for whom the prescription was written even if speaking directly to the prescriber. (New Jersey Board of Pharmacy Newsletter July 2006) c. Approved Narcotic Controlled Substances for Maintenance of Detoxification Treatment (CIII, IV, and V) (1) Effective as of June 23, 2005, the _____(2) regulations allow qualified practitioners not registered as part of a narcotic treatment program to dispense and prescribe CDS approved for the use in maintenance or detoxification treatment. (2) Practitioners are required to include the identification number on the prescription or written notice that "acting under the ____ _____(10) exception". (21 CFR §1301.28(e)) (21 CFR § 1306.05 (a)) (a) An individual practitioner may begin to prescribe or dispense narcotic drugs to a specific individual patient before receiving an identification number from the Administrator if the following conditions are met: (i) The individual practitioner has submitted a written notification in good faith to the Secretary of Health and Human Services. (ii) The individual practitioner believes reasonably believes that he or she is registered and that the drugs used are approved for maintenance/ detoxifiation. (iii) The individual practitioner reasonably believes that the treatment of the individual patient would be facilitated if narcotic drugs are prescribed or dispensed before the sooner of: --Receipt of and identification number --Expiration of the 45-day period (iv) The individual practitioner has notified both the Secretary of Health and Human Services and the Administrator of his or her intent to begin prescribing or dispensing the narcotic drugs expiration of the 45-day period. (v) The Secretary has not notified the registrant that he or she is not qualified. (vi) The individual practitioner has the appropriate registration. (3) In order to be valid, a prescription must be written for a legitimate medical purpose by a practitioner acting in his or her usual course of professional practice. (4) Prescriptions must be dated and signed on day issued, contain full name and address of patient, the drug name, strength, dosage form, quantity prescribed, directions of use, and name, address and registration number of practitioner. (5) Practitioners are required to keep records of prescriptions of CDS used for maintenance/detoxification treatment.

1. 3 2. name, address 3. annual 4. power of attorney 5. void 6. brown 7. green 8. blue 9. 60 10. separate 11. number 12. date 13. pharmacist 14. DEA 15. 2

Pg. 53/54 Obtaining Controlled Substances Execution of DEA Form 222 (21 CFR 1305.12 and .14) (OLD) (1) All ____(1) copies completed at once -- typewriter, pen or indelible pencil. (2) _____ and __________(2) of supplier must be entered. Only one supplier per form. (3) 10 lines per form, one item per line, each strength is a separate item. (4) Must be signed by person signing the most recent _______(3) application - or person to whom ability delegated by ________ ____ _______(4). Keep ________ ____ _______(4) in the file --- do not mail. (See 21 CFR 1305.05). (5) No erasures; if make error must ______(5) form and keep. If wish to change order draw single line through "item" and write "canceled" in space provided for the number of packages. (6) Copies 1 (the original)(_______(6)) and 2 (______(7)) with carbon sent to supplier. (Question on licensure exam) (7) Retain Copy 3 (________(8))(purchaser). (Question on licensure exam) (8) Copy 1 retained by supplier. Copy 2 sent to the Special Agent in charge of DEA in that region. Supplier must complete shipment pursuant to order form within ____(9) days. (9) Number of lines completed on the forms must be noted on the bottom of the form where requested. (10) Catentanil, etorphine HCl and diprenorphine must be ordered by __________(10) 222 form. d. Receipt of Schedule II (21 CFR 1305.13(e)) (IMPORTANT) Purchaser must record the following on Copy 3 (retained): (1) ________(!1) of bulk containers received. (2) _______(12) received. (3) While not in regulation only ________(13) should check in CII's. e. Additional Uses of DEA Form 222 (1) Returns of CII; wholesaler issues form to pharmacy, pharmacy retains copy #1, sends copy #2 to _______(14). (2) Purchase by Physician, physician submits form to pharmacy as above. f. Records (21 CFR 1305.16-17) (1) Executed order forms must be kept at the registered location for ____(15) years. (2) Lost or theft of order forms must be reported to Special Agent in charge of DEA in area's Divisional office. Must give serial number of forms lost or stolen. If a purchaser learns an unfilled order form was lost he fills out a new "222" and attaches a statement containing the form # lost and the fact the goods were not received. Copy 3 of the second form must be retained with copy 3 of the lost form and the statement. Statement must also be attached to copy and 2 of the new 222.

1. beginning 2. biennial 3. federal register 4. exact 5. estimate 6. 1000

Pg. 55/56 Records Inventory a. _________(!) inventory (when you first open pharmacy) All CDS "on-hand" if they are in the possession of or under the control of the registrant (returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on behalf of the registrant and intended for distribution as complementary samples) on the date the pharmacy first dispenses a CDS (21 CFR 304.11(a)). (must be accurate because all other inventories rely on it) b. __________(2) Inventory Must inventory all CDS at least every two years on any date which is within two years of the previous date (21 CFR 1304.11(c)). c. Newly Scheduled Drugs Date of inventory specified in ______ _________(3). Thereafter on the biennial date. (21 CFR 1304.11(d)). (For example, Tramadol was rescheduled to a CIV on August 18,2014) ) d. Required Information Contained in Inventory Record (21 C.F.R. 1304.11(1) and (3)): (1) Date and time of inventory; (2) Signature of person(s) responsible for taking inventory; (3) Name of CDS; (4) Dosage form/unit strength/concentration; (5) Number of units or volume in each commercial container; (a) CI or CII ________(4) count. (b) CIII, CIV, CV _________(5) , unless container originally held _______(6) or more. (6) Number commercial containers; (7) Total quantity of substance in all forms to nearest unit weight; (8) Inventory, written or typed and if done in oral recording must be promptly transcribed (in a few days); (9) Instructions provided; (10) Separate inventories required for each separate location and each separate activity registered for.

1. DEA 2. dispenser 3. distributor 4. last 5. verification 6. legitimate 7. office

Pg. 57/58 PRESCRIPTIONS FOR CONTROLLED DANGEROUS SUBSTANCES 1. PRACTITIONERS a. Must be licensed by state and registered or exempt from registration under CSA. LICENSURE EXAM! b. ________(1) NUMBER - 9 characters (1) first character - A, B (________(2)) or P (________(3)). (2) second character - first letter of registrant's _____(4) name. (3) third through eighth digits - unique. (4) ninth digit - __________(5) number. c. i.e.: BR5917248 5 + 1 + 2 = 8 (Add 1st, 3rd and 5th digit) (9 + 7 + 4) x 2 = 40 (Add 2nd, 4th and 6th digits and multiply by 2) 8 (Right most digits must correspond to the last number in the DEA number) 2. PURPOSE OF ISSUE a. Rx must be issued for a __________(6) medical purpose. The responsibility for the proper prescribing and dispensing rests with the prescriber and also with the pharmacist. (Corresponding responsibility). Anorder purporting to be a prescription issued not in the usual course of professional treatment is not a prescription. If one knowingly fills a purported prescription they are subject to punishment. (21 CFR 1306.04(a)), (See also U.S. v. Hayes 595 F. 2nd 258 (5th Cir 1979). b. May not fill MD request for CII's for _______(7) dispensing. c. Practices which should alert RPh to unauthorized or inappropriate prescribing. (1) Larger quantities prescribed by prescriber as compared to other prescribers of same specialty. (2) Dose, quantity, combination drugs outside of accepted medical practice. (3) Irrational combinations frequently prescribed. (4) Patients travel to pharmacy to have prescription filled. (5) Erasures, misspellings, hospital Rx's (esp. VAMC = Veterans Administration Medical Center), alterations. (6) Nonexistent person. d. See also Ryan v. Dan's Food Stores 972 P. 2d 359 (Utah 1998) regarding too much thoroughness on CII prescriptions.

1. full 2. DEA 3. electronic 4. issued 5. 90

Pg. 58/59 PRESCRIPTIONS FOR CONTROLLED DANGEROUS SUBSTANCES CDS PRESCRIPTION REQUIREMENTS (21 CFR 1306.05) (See N.J.A.C. 8:65-7.5 and 13:35-7.2 for New Jersey Rules) The written prescription must contain the following: a. _____(1) name and address of patient (pharmacist must fill this in if missing); b. Drug name, strength, dosage form, quantity prescribed and directions for use. c. Name, address and ______(2) No. of Prescriber (If exempt use hospital or institution registration number & the special internal code assigned to him or her); d. Written in ink, indelible pencil, or typed but _____(3) control substance prescriptions including CII's are now allowed;. e. Date ______(4); cannot postdate except for the ____(5) day rule exception. f. Manually signed (on date issued) (unless ____(3)). (1) No signature stamp. (2) No RN or receptionist. (Can write Rx but not sign) g. There are numerous regulations on digital certificates for electronic prescriptions. 21 CFR 1311. h. The following items cannot be changed on a hardcopy CII prescription: patient's name (other than to correct the spelling), CDS prescribed (except to substitute a generic) and the prescribers signature (NJ Office Of the Attorney General Letter June 15, 2014). i. the following items may be changed on a hardcopy CII prescription after consultation with the prescriber: patient's address (if incorrect), drug strength, drug quantity (both numeric and alpha representations), drug dosage form, directions for use, date issued, DEA number (if omitted). (NJ Office Of the Attorney General Letter June 15, 2014). j. The following items may be added on a hardcopy CII prescription without consultation with the prescriber: the patient's address (if ommited), date of birth and notation to correct misspelled name.(NJ Office Of the Attorney General Letter June 15, 2014). k. A CIII-CV narcotic drug approved for "detoxification treatment" or "maintenance treatment" must include the special prescriber DEA number (beginning with X) or must note on the face of the prescription they are acting under good faith exception. l. if the prescription is for gamma-hydroxybutyric acid, the practitioner must note on the face of the prescription the medical need of the patient for the precription

1. 30 2. before 3. direct 4. LTCF 5. hospice 6. 90 7. earliest date 8. diversion 9. 30 10. 72 11. 7 12. DEA

Pg. 59/60 PRESCRIPTIONS FOR CONTROLLED DANGEROUS SUBSTANCES Schedule II Dispensing Requirements (Heavily tested) a. Except in emergency only pursuant to valid, written or electronic Rx. (1) Only valid for ___(1) days. (2) Can be faxed if have original prescription _______(2) dispensing (21 CFR 1306.11). See N.J. rules which are similar (N.J.A.C. 13:39-7.10(h)) but there are exceptions. 3) A facsimile prescription is also allowed (and serves as the original) in the following circumstances: a) for ______(3) administration to a patient (IV, IM, SQ, parenteral or intraspinal infusion) b) for a resident in a ________(4) c) for a patient in a ______(5) care program certified and/or paid for by Medicare or a _______(5) program licensed by the state. b. No Refills. (21C.F.R. 1306.12). May issue multiple prescriptions for a ____(6) day supply. Each of 3 prescriptions must be for a legitimate medical purpose, must indicate on other than the first prescription the _____ _____(7) it may be filled and it must not create an undue risk of ________(8). (Also valid in NJ. See N.J.S.A. 5:9-22.9 and N.J.A.C. 8:65-7.5. c. If written no quantity limitation, can dispense "required amount". See N.J. rules which only allow ___(9) days (N.J.A.C. 13:35-7.6) but there are exceptions. d. Emergency oral CII prescriptions (21 CFR 130.11(d)): (1) All 3 determinations must be made to determine if an emergency exists (21 CFR 290.10): (a) Emergency administration of CII is needed for patient's care; (b) No proper alternative available; (c) Not readily possible for prescriber to present a written Rx prior to dispensing . (2) When receiving emergency oral CII (must get from prescriber) RPh must: (a) Reduce Rx to writing with all required information; (b) Make reasonable effort to determine prescriber's authority (if not known) (i.e. - call back). (3) Was a ____(10) hour supply maximum if taken in accordance with directions can be dispensed but now changed to "what is necessary to treat the patient during the emergency period." NJ still ____(10) hours supply. In an emergency situation if the prescription is partially filled the balance must be filled no later than ____(10) hours after the prescription is issued. (4) Prescriber must supply RPh with written Rx covering order within ____(11) days of oral order. See N.J. rules which require it in ____(11) days also. N.J.A.C. 8:65-7.8. (a) Prescription must have "Authorization for Emergency Dispensing" written on face and dated as of date of oral order. (i) Original delivered by hand or mail (postmarked within ___(11) day period). #7546579.1 45 (ii) Upon receipt attach to oral Rx reduced to writing (see explanation N.J.A.C. 13:39-7.3). (b) If not provided RPh must notify ____(12). (Prof C said make an effort to call prescriber) (See page A168). e. Partial Filling CII (21 CFR 1306.13) (1) Must note partial filling on Rx; date and quantity (2) Must complete order within 30 days after the date of the prescription is written. NJ is still ___(10) hours. (3) Exceptions for long-term care facilities: Pharmacist must record on the prescription "terminally ill" or "______"(4). CII prescriptions for patients in _____(4) or with a medical diagnosis documenting a terminal illness are valid for a period to not exceed 60 days from the issue date unless discontinued sooner. (4) If full quantity not available or requested by the practitioner or the patient. 5) Cannot exceed the quantity on the prescription.

1. oral 2. fax 3. 5 4. 6

Pg. 60 PRESCRIPTIONS FOR CONTROLLED DANGEROUS SUBSTANCES DISPENSING SCHEDULE III OR IV a. Rx may be _______(1) (if written by MD can be communicated by employee-21 CFR 1306.03(b)) written or electronic. (1) Reduce ______(1) to writing: date, time, who (21 CFR 1306.21 (a)). (2) ___(2) allowed (21 CFR 1306.21(a)). See N.J. rules which are similar. (N.J.A.C. 13:39-7.10(i)). b. Refills (1) If authorized up to ___(3) times in ___(4) months since date of Rx written(can call MD and get refills increased but no more than the maximum and pharmacist must note on back of Rx the date, quantity of refill, number of additional refills and initial it.) (21 C.F.R. 1306.22(a)). (2) Rx valid for ___(4) months from date issued (21 CFR 1306.22) (in NJ: 30 days, N.J.A.C. 8:65-7.5 (a)) Can authorize oral more refills until in above limits. c. Partial filling allowed... the total qty dispensed in all the partial fillings does not exceed the total qty prescribed and no dispensing occurs after ____(4) months from the date the RX was written. There is no mention that this can only be done if the pharmacist does not have the full qty in stock. d. Refills must be recorded on the back of the Rx or on the computer (21 CFR 1306.22(b))

1. 225 2. 363

Prof C said to know the form #s. Pg 50: Other DEA Forms 1. Form _______: to manufacture or distribute 2. Form ______: to conduct a narcotic treatment center ro to be a compounder

1. Attorney general 2. C

Schedules of CDS Pg 51 (Exam Questions look at purple book) Scheduling decisions Made by the _________ ___________(1) Factors Considered (21 USCS 811(c)): (1) Actual or relative potential for abuse; (2) Scientific evidence of pharmacological effects, if known; (3) State of scientific knowledge regarding the substance; (4) History, scope, current patters of use/abuse; (5) Risk to public health; (6) Psychologic or physiologic dependance potential; (7) Whether substance is an immediate precursor of an existing CDS. d. Symbol "___" (2) with schedule numbers must be placed on manufacturer's label of all substances distributed which contain a CDS - allow prompt identification. (21 CFR 1302.03.) e. Commercial Containers The symbol shall be prominently located on the label or labeling clearly and large enough to afford easy identification without removal from the dispenser's shelf (21 CFR 1302.04).