Juris Fed Law

Comprehensive Drug Abuse Prevention and Control Act of 1970 (CSA)

-creates a closed system of distribution
-Subchapter 1 provides guidance on control and enforcement of controlled substances
-Subchapter 2 provides guidance on importation and exportation of controlled substances

Drug Enforcement Administration (DEA) responsibilities

all parts of the CSA

State and federal law authority

-State law should NOT be less strict than federal (pharmacists must follow the stricter of the state and federal law)
-If no state law-\> must follow federal law

Definition of Schedule 1 controlled substances

-high potential for abuse, have no currently accepted medical use in treatment in the US, and there is lack of accepted safety for use of the drug or other substance under medical supervision

examples of Schedule 1 controlled substances

-heroin
-LSD
-cannabis
-peyote
-methaqualone
-3,4 methylenedioxymethamphetamine (MDMA)

Definition of schedule 2 controlled substances

-high potential for abuse which may lead to severe psychological or physical dependence, but have a currently accepted medical use in treatment in the US or currently accepted medical use with severe restrictions

Examples of schedule 2 controlled substances

-morphine
-codeine
-opium
-hydrocodone
-hydromorphone
-methadone
-meperidine
-oxycodone
-fentanyl
-ampetamine
-methamphetamine
-methylphenidate
-lisdexamfetamine
-cocaine
-amobarbital
-gluthethimide

definition of schedule 3 controlled substances

potential for abuse less than substances in schedules 1 or 2 and abuse may lead to moderate or low physical dependence or high psychological dependence

examples of schedule 3 controlled substances

-tylenol with codeine (not more than 90 mg of codeine per dosage unit)
-buprenorphine
-benzphetamine
-phendimetrazine
-ketamine
-anabolic steroids (testosterone)

definition of schedule 4 controlled substances

low potential for abuse relative to substances in 3, have a currently accepted medical use in treatment in the US, and abuse may lead to limited physical dependence or psychological dependence relative to substances in schedule 3

examples of schedule 4 controlled substances

-tramadol
-alprazolam
-clonazepam
-clorazepate
-diazepam
-lorazepam
-midazolam
-temazepam
-triazolam

Definition of schedule 5 controlled substances

low potential for abuse relative to substances listed in schedule 4, have a currently accepted medical use in treatment in the US, and abuse may lead to limited physical dependence or psychological dependence relative to substances in schedule 4

examples of schedule 5 controlled substances

cough preparations containing not more than 200 mg of codeine per 100 mL or per 100 g (robitussion AC and phenergan with codeine)

What does the secretary of the department of health and human services do?

provides information on:
-abuse potential
-pharmacological effects
-state of current scientific knowledge
-history and current pattern of abuse
-scope, duration and significance of abuse
-risk to public health
-dependence liability
-precursor to a current controlled substance

What can the attorney general do?

After receiving information from secretary of the DHHS-\>
attorney general can add, remove, change things related to scheduled controlled substances
-if the secretary recommends not to schedule the AG must comply (except if there is imminent hazard)

How to schedule a new drug

-manufacturer must submit an NDA to the secretary if the new drug has stimulant, depressant, or hallucinogenic effect on the CNS
-Secretary forwards information to attorney general if drug has potential for abuse

How often do manufacturers and distributors have to renew their controlled substance licenses?

every 1 year

How often do dispensers (pharmacies and practitioners) register with the DEA?

every 3 years

exceptions to the registration with DEA

-employee acting in usual course of business (pharmacist)
-common or contract carrier in the usual course of business (Cardinal driver)
-End user (patient)

T/F: Individual prescribers must be registered with DEA to prescribe

TRUE: this includes physicians, dentists, vets, etc

Exception to who has to be registered with the DEA

hospital intern, resident, or foreign trained physician

Pharmacy registration with DEA

-every pharmacy that dispenses a controlled substance must be registered with DEA
-must have a state license first
-FORM 224
-If you own multiple pharmacies, need to have a license for each pharmacy
-Renewed every 3 YEARS via 224a form no early that 60 days prior to current expiration date

What happens if the business address changes for registration with DEA?

-modification of registration request can be requested online or in writing to the local DEA registration program specialist
-must maintain the new certificate with the old certificate until expiration
-change in state you have to have a new state license before modification

What happens if you need to terminate registration with DEA?

must return its DEA registration certificate and unused official order forms to the local DEA registration program specialist

What happens with DEA registration if transfer of business

-pharmacy registrant must submit in person or by registered or certified mail, return receipt requested, to the special agent in charge in his or her area, at least 14 years in advanced of date of proposed transfer
-transferor must provider name, address, registration number, and authorized business activity
-transferee must provide name, address, registration number, and authorized business activity
-they must also say if the business activities will be continues at the location registered by the person discontinuing the business, or moved to another location
-the date on which the transfer of controlled substances will occur

How does a transfer of business occur with DEA

-complete inventory must be taken
documents that state the drug name, dosage form, drug strength, quantity, and date transferred (C3-5)
-Form 222 to document C2
-Serves as final and initial inventory for the pharmacies
-Copy of the inventory must be included in the records of each pharmacy
-acquiring pharmacy must maintain all records involved in the transfer for two years

What happens if there is a denial of registration in the public interest

CSA provides that the following factors are to be considered
-recommendation of the appropriate state licensing board
-applicants experience in dispensing controlled substances
-applicants conviction record under federal or state laws relating to the manufacture, distribution or dispensing of controlled subtances
-compliance with applicable state, federal, or local laws relating to controlled substances
-such other conduct which may threaten the public health and safety

What happens if a pharmacies registration is revoked or suspended

DEA has the authority to suspend or revoke a DEA registration upon a finding that the registrant has:
-falsified application
-convicted of a felony relating to a controlled substance
-state license or registration has been suspended, revoked or denied
-committed such acts as would render its registration inconsistent with the public interest as determined under 21 U.S.C
-excluded from participation in a program pursuant to 42 USC (medicare and state health care programs)

Chemical registration requirements for pharmacy registrations

registration is not required for regulated sellers of scheduled listed chemical products (ephedrine, pseudoephedrine, phenylpropanolamine)

Ordering a C1 or C2 controlled substance

-mandated use of a single sheet DEA 222 order form or the electronic equivalent

Exceptions for C1 and C2 ordering

-delivery from a central fill pharmacy to a retail pharmacy
-distributions to reverse distributors and distributors by collectors and law enforcement
-deliveries of controlled substances from ultimate users for the purpose of recalls

Completing DEA forms 222

-non-eraseable ink
-number of lines completed must be noted on that form at the bottom of the form
-record name and address of supplier from whom the controlled substances are being ordered (one per form)
-purchaser must make copy of original Form 222 for its records and then submit to original supplier
-power of attorney needs to sign Form 222 (need registrant, person to whom the power of attorney is being granted, two witnesses)

What happens with cancellation and voiding of DEA forms 222?

-purchaser may cancel part or all of an order on a form by notifying supplier in writing of the cancellation
-supplier must indicate the cancellation on the original form sent by the purchaser by drawing a line through the canceled items and printing 'canceled' in the space provided for the number of items shipped

What happens if DEA Forms 22 are lost or stolen?

-must immediately report the loss or theft to the local DEA Diversion Field Office
-provide serial numbers
-If found notify the local DEA diversion field office

CSOS and Electronic Order Forms (222) definition

-allows for secure electronic controlled substances orders without the supporting paper DEA form 222
-requires that each individual purchaser enroll with DEA to acquire a CSOS certificate

Benefits of CSOS and Electronic Order forms (222)

-Ordering freedom: can order a C1-CV and no line limit
-Faster transactions: timely and accurate validation by the supplier
-Accurate Orders: CSOS reduces the number and ordering errors
-Decreased cost: order accuracy and decreased paperwork results in a lower transaction cost

Ordering Schedules 3-5 Controlled Substances

-must keep a receipt (invoice or packing slip) on which it records the date the drugs were received and confirm that the order is accurate
-must include name, strength, number of units, how much, name address and registration number of the person from whom the units were acquired
-receipts should be maintained separately from other records of the registrant.

Inventory definition

-complete and accurate list of all stocks and forms of controlled substances in possession of registrant on date inventory is taken
-records must be maintained at registered location for at least two years

C2 inventory

determined by an actual physical count
-records must be kept separate from all other records of the pharmacy

C3-5 inventory

-estimated count or measure of content of an open bottle that contains no more than 1,000 tablets
-If greater than 1000, exact count must be made
-records must be maintained either separately from all other records of the pharmacy or in such form that the information required is readily retrieveable form ordinary business records

Initial inventory of controlled substances

-registrant MUST take initial inventory (actual physical count of all controls in their possession)
-Record open or close of business day
-If zero you have to show zero in records
-DO NOT need to submit a copy to DEA

Biennial Inventory

-Every 2 years
-requires same information of initial inventory
-DO NOT need to submit copy to DEA

Newly scheduled controlled substance inventory

must be inventoried as the effective date of scheduling

Inventory for Damaged, Defective, or Impure Substances

-Name of substance
-total quantity
reason for the substance being maintained by the registrant and whether each substance is capable of use in the manufacture of any controlled substance in finished form (outdates)

Notes on an Inventory of controlled substances

-recommended, but not required by DEA
-name, address, DEA registration number of registrant and signature of person who took inventory
-package sizes are listed separately

What does "readily retrievable" mean?

1. records are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems in such a manner that they can be separated out of all other records in reasonable time
2. certain items are asterisked, redlined, or in some manner visually identifiable apart from other items appearing in record

The records which must be maintained by a pharmacy are:

-reports of theft or significant loss (form 106)
-registrant record of controlled substances destroyed (DEA Form 41)
-DEA registration certificate
-Self certification certificate and logbook as required under CMEA of 2005

What are the two options for filing paper prescription records?

Option 1: 3 separate files (C2, C3, non controls)
Option 2: 2 separate files (C2, all other drugs dispensed by controls much be readily retrievable with use of a red "C")

Electronic prescription records

• If a prescription is created, signed, transmitted, and received electronically, all records related to that prescription must be retained electronically.
• Electronic records must be maintained electronically for two years from the date of their creation or receipt.
• Records regarding controlled substances must be readily retrievable from all other records.
Electronic records must be easily readable or easily rendered into a format that a person can read.

Valid prescription requirements

-date written
-prescriber signature
-Patient full name and address
-Prescriber full name and address
-Prescriber DEA number
-Drug name
-Drug strength
-Dosage form
-Quantity prescribed
-Directions for use
-Number of refills authorized

Registrant CSOS enrollment

-DEA-251
-the individual who signed the most recent, or is authorized to sign the next, DEA registration renewal application (DEA form 223) for your organization
-Signs controlled substance orders

Coordinator CSOC enrollment

-DEA -252
-a required administrative role for each DEA registration number
-registrant can also serve as this role
-optional to sign controlled substance orders

Power of Attorney enrollment

-DEA-253
-any other individual authorized to sign controlled substance orders
-signs controlled substance order

What can be changed or added to a controlled substance prescription with practitioner authorization?

-Practitioner/Institutional DEA\#
-Directions
-Code
-MDD
-Strength

What can an RPh add without practitioner authorization to a controlled substance prescription?

-Patient Address
-Patient Sex
-Patient Age

What can a pharmacist NEVER add to a controlled substance prescription?

-Patient name
-Practitioner signature
-Date written
-Drug name
-Quantity

What can an RPh CHANGE with practitioner authorization on a controlled substance prescription?

-Practitioner/Institutional DEA\#
-Directions
-Code
-Quantity
-MDD
-Strength
-Dosage form

What can an RPh CHANGE without practitioner authorization on a controlled substance prescription?

-Patient address
-Patient Sex
-Patient Age

What can an RPh NEVER change on a controlled substance prescription?

-Patient name
-Practitioner signature
-Date written
-Drug name

Who may issue a prescription for a controlled substance?

-authorized to prescribe a controlled substance by the jurisdiction is which the practitioner is licensed to practice
-registered with DEA or exempted from registration (public health service, federal bureau of prisons, military practitioners) OR
-Is an agent or employee of a hospital or other institution acting in the normal course of business or employment under the registration of the hospital or other institution which is registered in lieu of the individual practitioner being registered

Acts that an Agent may execute C3-5

-an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser
-An authorized agent of an individual practitioner may prepare a written prescription for the signature of the practitioner
-An authorized agent, that agent may telephone the pharmacy and convey that prescription information to the pharmacist
-the practitioners agent may transmit the practitioner-signed prescription by facsimile
-medical determination of need for a controlled substance prescription cannot be delegated

C2 prescriptions

-must receive the original, manually signed paper prescription or an electronic prescription prior to dispensing
exceptions: a person in hospice, long term care facility, compounded for the direct administration to the patient
-the facsimile prescription serves as the original written prescription for the pharmacy. No further documentation is required

Emergency oral communication of a valid C2 prescription

-May not be delegated to an authorized agent
-DEA regulations limit such an emergency oral prescription to the quantity necessary to treat the patient during the emergency period and require that it be followed up within 7 days by a practitioner sign, written prescription to the dispensing pharmacy

Oral authorization for schedules 3-5 prescriptions

a pharmacist may dispense a controlled substances pursuant to an oral prescription made by an individual practitioner and communicated by the practitioner or their authorized agent, and promptly reduced to writing by the pharmacist containing all information required for a valid prescription except for the signature of the practitioner

Facsimile prescriptions for schedules 3-5 controlled substances

prescriptions for schedules 3-5 controlled substances may be transmitted by facsimile from the practitioner or the practitioner's agent to the dispensing pharmacy. The facsimile is considered to be equivalent to an original prescription as long as the practitioner has manually signed the prescription

Electronic prescriptions

-Electronic pharmacy applications that comply with all DEA's requirements as set forth in 21 CFR part 1311 may be used by DEA registered pharmacies to electronically receive and archive controlled substances prescriptions and dispense controlled substances based on these prescriptions

What happens if there is a duplicate prescription (paper and electronic)?

-if paper or oral prescription received, pharmacist must check to see if the electronic prescription was not received. If it was, one of them is voided
-If a pharmacists receives a paper or oral prescription that was originally transmitted electronically to another pharmacy, the pharmacist must check with that pharmacy to determined whether the Rx was dispensed

Is there a time limit federally in which a C2 must be filled?

No

When is an oral order permitted?

Emergency situations only
-must send cover within 7 days

Federal rules for issuance of multiple C2 prescriptions

-Practitioner can issue multiple prescriptions authorizing the patient to receive a total of up to 90 day supply of a C2 as long as
1. separate prescription must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice
2. written instructions on each prescription indicating the earliest date on which a pharmacy may fill each prescription
3. does not create an undue risk of diversion or abuse
4. permissible under applicable state laws
5. fully with all other applicable requirements under the CSA and CFA as well as any additional requirements under state law

How can a C2 be expedited in filling?

-a prescriber may transmit a C2 prescription to the pharmacy by facsimile
-original C2 prescription must be presented to the pharmacist and verified against facsimile prior to actual dispensing of controlled substance
Exceptions where facsimile serves as written prescription and no further documentation is required: Compounded for direct administration to patient, long term care, patient enrolled in hospice program

Possible C3-5 ways a prescription can be filled

-paper prescription signed by practitoner
-facsimile of a signed paper prescription transmitted by the practitioner or the practitioner's agent
-electronic prescription that meets DEA requirements
-Call- in prescription

C3-5 refills

-may be refilled if authorized on the prescription
-may only be refilled up to 5 times within 6 months after date of issue

What is entered on back on C3-5 prescription when refilled?

-Pharmacist initials
-date the prescription was refilled
-amount of drug dispensed on refill

Construction of Valid DEA numbers

-First letter\= type of registration
-Second letter\= first letter of last name
-first 6 digits are computer generated and last digit is check digit
-Checked digit \= (1st + 3rd + 5th) + 2x(2nd + 4th + 6th) \= 7th

Electronic recordkeeping of schedules 3-5 refill information

-in lieu of such a printout "daily control log" , the pharmacy must maintain a bound logbook or a separate file in which each pharmacist involved in the day's dispensing signs a statement
-pharmacy must have a backup procedure if there is downtime

Transfer of Schedules 3-5 prescription information (non-ePrescription) rules

-can transfer to another pharmacy for refill dispensing, NOT an unfilled prescription
-one-time basis and only communication between 2 licensed pharmacists

Transferring pharmacist must record the following information for transfers

-pharmacist writes "VOID" on the face of the prescription and records the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information as well as the date of transfer and name of pharmacist transferring

Receiving pharmacist must record the following information for transfer

-write word "transfer" on the face of the transferred script
-date of issuance of original prescription
-original number of refills authorized on original prescription
-Date of original dispensing
-number of valid refills remaining and dates on locations of previous refills
-pharmacy's name, address, DEA registration number, and prescription number from prescription transfer
-name of pharmacist who transferred prescription
-pharmacy's name, address, DEA registration number and prescription number from which the prescription was originally filled

Transferring E prescriptions for controlled substances

-the transferring pharmacist must provide the receiving pharmacist with the following information in addition to the original electronic prescription data:
-date of the original dispensing
-number of refills remaining and dates and locations of previous refills
-transferring pharmacy's name, address, DEA number, and prescription number for each dispensing
-the name, address, DEA registration number and prescription number from the pharmacy that originaly filled the prescription if different
-the pharmacist receiving a transferred electronic prescription must create an electronic record that includes the receiving pharmacists name and all the information

Dispensing labeling requirements for a transferred controlled substance

-date of filling
-pharmacy name and address
-prescription number
-name of the patient
-name of prescribing practitioner
-directions for use
-cautionary statement: "federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"

Partial dispensing of C2's

-notes the quantity supplied on front of prescription or in prescription record
-remaining portion may be dispensed within 72 hours
-if remaining portion is not or cannot be filled within 72 hour period, the pharmacist must notify the prescribing practitioner
-no further quantity may be supplied beyond 72 hours without a new prescription

Comprehensive Addiction and Recovery Act of 2016

permits a prescription for a controlled substance in C2 to be partially filled at the request of the patient or the prescribing practitioner if:
-partial filling is not prohibited by state law
-prescription is written and filled in accordance with the CSA
-total quantity dispensed in all partial fillings does not exceed total quantity prescribed
-shall be filled not later than 30 days after the date on which the prescription was written

What is a LTCF?

Defined in the CFR as a nursing home, retirement care, mental care, or other facility or institution, which provides extended health care to resident patients

Partial filling of C2's for terminally ill or LTCF

-for these specific patients, may be filled in partial quantities to include individual dosage units
-pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient"
-date of partial filling, quantity dispensed, remaining quantity authorized to be dispensed and identification of the dispensing pharmacist
-C2 prescription are valid not to exceed 60 days from issue date

Partial dispensing of C3-5 controlled substances

-each partial filling is recorded in the same manner as a refilling
-partial fillings cannot exceed total quantity prescribed
-no dispensing occurs beyond 6 months from date on which it was issued

Dispensing a controlled substance without a prescription

-controlled substance which is not a prescription drug as determined under Federal food, drug, and cosmetic act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, as long as:
1. dispensing is only made by a pharmacist
2. Not more than 240 cc or 48 doses of any controlled substance containing opium in 48 hr
3. Not more than 120 cc or 24 doses of any such controlled substance containing any other such controlled substance in 48 hours
4. suitable identification
5. person is 18
6. name/address of purchaser, name/quantity of controlled substance purchased, date of each purchase, name or initials of the pharmacist who dispensed
7. prescription is not required for distribution or dispensing of substance to any federal, state, or local law
8. central fill pharmacies may not dispense controlled substances at retail level to a purchaser

Form that is used for on-site destruction of controlled substances

Form 41

How can controlled substances be disposed?

1. Return to supplier
2. Send to Reverse Distributor
3. Disposal or destruction by pharmacy (disfavored by DEA, but permitted by law)
4. request assistance from special agent in charge

Authorized collectors of controlled substances (e.g. manufacturers, hospitals, retail pharmacies)

-retail pharmacies and hospitals/clinics with on-site pharmacies may modify their registrations to obtain authorization to be a collector
-controlled substances that are lawfully possessed by an ultimate user or other authorized non-registrant person may be collected
-authorized collectors shall not permit an ultimate user to transfer such substance to any person for any reason
-Shall not be counted, sorted, inventoried, or handled

Long term care facilities and controlled substance receptacles

-only authorized retail pharmacies and authorized hospitals/clinics with an on-site pharmacy may install, manage, and maintain collection receptacles at LTCF's and remove, seal, transfer, and store or supervise the removal, sealing, transfer and storage of sealed inner liners at LTCFs
-Maintenance is performed by employee of authorized retail pharmacy and one supervisor level employee of the LTCF or two employees of the authorized collector

What is a central fill pharmacy?

-permitted to prepare both initial and refill prescriptions
-C2-5 may be transmitted electronically from a retail pharmacy to a central fill pharmacy including via fax

Requirements for retail pharmacy transmitting prescription to central fill pharmacy

-write words "central fill" on face of original prescription and record name, address, DEA registration number of central fill pharmacy as well as name of retail pharmacy pharmacist transmitting the prescription, and date of transmission
-ensure that all information required to be on prescription is transmitted to the central fill pharmacy
-maintain original prescription for 2 years
-keep receipt of transmission including date and method of delivery and name of employee accepting delivery
-C3-5 -\> indicate the number of refills already dispensed and the number of refills remaining

Requirements for central fill pharmacy receiving retail pharmacy transmission

-keep copy of prescription
-keep record of date of receipt of transmitted prescription, name of licensed pharmacist filling prescription, and dates of filling or refilling of prescription
-Keep record of date the filled prescription was delivered to retail pharmacy and method of delivery

Automated dispensing systems by retail pharmacies at LTCF

-separate registration at the location of each long term care facility at which automated dispensing systems are located
-Drugs in ADS are counted as pharmacy stock

What does BNE do?

1. investigate and enforcement
2. Data management and analysis
3. Regulatory Compliance Unit (Licensing) and drug destruction
4. Health initiatives

What does Public health initiatives and administration do?

-administer official prescription program, prescription monitoring, electronic prescribing mandate, mandatory prescriber education, grants
-conducts education and outreach
-helps formulate policy and regulations

What does Narcotic Investigations do?

-Conducts investigations, inspections, outreach
-Partners with law enforcement and regulatory agencies

What does data analysis in BNE do?

-reviews incoming data to ensure timeliness and accuracy
-works with IT on all new initiatives
-Conducts data analysis for Bureau initiatives

What does regulatory compliance for BNE do?

-issues licenses, certifications, and permits