Law - Csa Exam I

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CSA

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Title 21, Chapter II Code of Federal Regulations (21 CFR, Part 1300 to end)

Part of Drug Abuse Prevention and Control Act of 1970

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CSA

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Pharmacists must make sure they understand and comply with the laws governing pharmacy in their individual states of practice
Many state laws are more stringent than federal law and must be complied with in addition to federal law.

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CSA

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Created to regulate:
Manufacturing
Distribution
Delivery
Dispensing
Of drugs that are subject to or have the potential for, abuse or psychological dependence

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CSA

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The primary purpose of this law is to prevent the diversion of controlled substances for illicit purposes.

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CSA

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The provisions of the CSA are designed to improve the administration and regulation of the manufacture, import/export, distribution and dispensing of controlled substances by creating what is referred to as a closed system

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CSA

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Substances controlled by this law can legally move only among those individuals and agencies registered with the Drug Enforcement Administration until they reach the ultimate user.

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Drug Enforcement Administration (DEA)

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The primary federal agency responsible for enforcement of the CSA
Cooperates with state and federal agencies, complies with international treaty obligations, works with domestic state and local agencies and private industry in the effort to prevent the diversion of controlled substances for illicit purposes.
The Department of Justice is the parent federal agency

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DEA Registration Required for:

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Manufacturing
Distribution
Dispensing
Conducting research
Conducting instructional activities
Importing or exporting
(for any substance included in this act)

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CSA

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Five Categories (Schedules) of Controlled Substances are defined by the CSA
Drugs are placed in the different categories by the Attorney General of the US
Drugs are placed in the different categories based on their individual potential for abuse
Designated C-I, C-II, C-III, C-IV and C-V

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Schedule I Substances

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Have high potential for abuse
No accepted medical use in the US
Research using these drugs is allowed
DEA registration is required

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Schedule I Substances Example

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LSD, methaqualone, heroin, mescaline, psilocybin and MDMA (Ecstasy)

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Schedule II Substances

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Have a high potential for abuse with severe psychological or physical dependence liability
Have an accepted medical use in the US
Are available for practitioners to prescribe, dispense and administer
Substances in this category include:
Narcotics
Stimulants
depressants

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Schedule III Substances

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Have an abuse potential which is less than those in C-II, but greater than those in C-IV

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Schedule IV Substances

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Have an abuse potential less than those listed in C-III and greater than those listed in C-V

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Schedule V Substances

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Have an abuse potential less than those in C-IV
Consist primarily of preparations containing limited quantities of certain narcotic and stimulant drugs
Generally for antitussive, antidiarrheal and analgesic purposes

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Registration

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DEA does not register pharmacists
Pharmacies are registered with the DEA on DEA Form-224
Registration must be renewed q 3 years
One owner, several pharmacies, EACH pharmacy must be registered
Change of pharmacy address requires new registration

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Registration

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Individual pharmacy renewal:
Form 224A
Multiple pharmacy (Chain) renewal:
DEA 224B

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Registration Renewal

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NOT AUTOMATIC
DEA may deny, revoke or suspend registration IF registrant:
Filed a falsified application
Has been convicted of a felony relating to a controlled substance or List I Chemical
Had his/her state pharmacy license or registration suspended, revoked or denied
Committed an act which would render his/her registration inconsistent with the public interest
Has been excluded from participation in a Medicaid or Medicare program due to fraudulent action

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Registration Renewal
Termination of Registration (voluntary)

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Must notify DEA in writing before closing the business
Must return any unused DEA Form-222 with the word VOID written across the face of each unused form
Must indicate what will be done with inventory
Must keep all records relating to controlled substance inventory for a minimum of 2 years (even if going out of business)

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Registration Renewal
Transfer of Business

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Must notify DEA in writing at least 14 days before the date of proposed transfer
Must include with written notice:
Name, address and registration number of current registrant
Name, address and registration number of registrant acquiring the pharmacy
New address if pharmacy is moving
The date on which controlled substances will be transferred

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Disposal of Controlled Substances (3 options)

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To another pharmacy

To a supplier or manufacturer

To an agency registered to dispose of CS known as a reverse distributor

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Disposal of Controlled Substances
transfer Schedule II substances

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To transfer Schedule II substances, The receiving Registrant must issue an Official Order Form (DEA Form-222, U.S. Official Order Forms - Schedules I & II) to the registrant transferring the drugs.

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Disposal of Controlled Substances
Transfer of C-III – V substances

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Transfer of C-III – V substances must be documented in writing to include name strength, dosage form, quantity and date transferred plus the name, address and DEA Registration numbers of both registrants
NO DEA FORM-222 required

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Disposal of Controlled Substances: inventory

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On the day the controlled substances are transferred to another pharmacy, a complete inventory must be taken which documents the drug names, dosage forms, strengths, quantities, and date transferred for all merchandise transferred
This becomes the final inventory record of the outgoing registrant and the initial inventory record of the registrant receiving the merchandise
Copies must be maintained by both parties for a minimum of two years

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Destruction of Controlled Substances

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Contact nearest DEA field office
Yearly destruction allowed
DEA FORM-41 (Registrant’s Inventory of Drugs Surrendered), and
Letter requesting permission required
Proposed date of destruction, names of two witnesses*, method to be used
Two weeks prior to proposed destruction

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Destruction of Controlled Substances: Prior DEA authorization

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Prior DEA authorization to destroy controlled substances is not necessary when an authorized member of a state law enforcement or regulatory agency witnesses the destruction.
Copies of a DEA Form-41 (or state controlled substance destruction form) must be forwarded to the local DEA Diversion Office after the destruction

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Destruction of Controlled Substances: Blanket Authorization for Destruction

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Blanket Authorization for Destruction of Controlled Substances may be issued by the DEA to hospitals, clinics or other Registrants having to dispose of used needles, syringes or other injectable objects containing controlled substances.
Application required to include frequency, quantity, security, method and responsible person in charge of destruction.
DEA Form-41 must be completed

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Security Requirements for Pharmacies

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Must keep Schedule II, III, IV and V controlled substances in a locked cabinet, OR
dispersed throughout the non-controlled inventory to deter theft
An electronic alarm is recommended

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Theft or Loss of Controlled Substances

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Report SIGNIFICANT losses to DEA immediately upon discovery via telephone, fax or written message
Notify local police
Complete DEA Form-106 (Report of Theft or Loss of Controlled Substances – original and one copy to DEA, one copy kept in inventory file of Registrant)

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Responsibility for In-Transit Loss

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Part or all of a shipment disappears or does not reach intended destination – Supplier is responsible for completing DEA FORM-106
Part of an order is discovered missing after the shipment has been received (signed for) by the Registrant – Pharmacy must complete DEA-Form-106 (Report of Theft or Loss of Controlled Substances)

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DEA-Form-106 (Report of Theft or Loss of CS)

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Original and one copy to local DEA Field office and one copy for pharmacy files
Information Required on the form:
Name and address of pharmacy 
DEA registration number of pharmacy 
Date of theft 
Name and telephone number of local police department notified 
Type of theft (night break in, armed robbery, etc.) 
Listing of symbols or cost code used by pharmacy in marking containers (if any) 
List of controlled substances missing from inventory

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Breakage/Spillage

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Does NOT constitute a LOSS
Must be reported
DEA Form-41 (Inventory of Drugs Surrendered) must be completed
Any recoverable product Must be disposed of as defined earlier

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Record Keeping Requirements

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All records for CS purchased, received, distributed, dispensed or otherwise disposed of must be kept for a minimum of TWO years

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Record Keeping Requirements CII-C V

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C-II records must be kept separate from all other records.
C-III, IV and V records must be kept separate from all other records OR in a form that is easily retrieved

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Records that must be maintained

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DEA Order Forms-222
Power of Attorney to sign DEA Form-222
Receipts, invoices
Initial and biennial inventories
Original Prescriptions
Transferred, destroyed, stolen drugs
DEA registration certificates
Central records ok with DEA permission

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Three Options for Prescription Records
(All Rx records must be readily retrievable)
Option 1

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Option 1 Three Separate Files
C-II Rx’s
C-III, IV, V Rx’s
All other Rx’s dispensed

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Prescription Records
(All Rx records must be readily retrievable)
Option 2

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Two Files
C-II Rx’s
All other drugs dispensed, controlled and non-controlled. If this method is used Rx’s for III, IV and V must be marked with a RED “C” NLT 1” high.
If pharmacy has electronic system that permits identification by Rx # and retrieval of original documents by prescriber’s name, patient’s name, drug dispensed and date filled, then the red “C” requirement is waived.

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Prescription Records
(All Rx records must be readily retrievable)
Option 3

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Two Files
C-II, III, IV and V Rx’s filed together. All other Rx’s filed separately
C-III, IV and V must be marked with a RED “C” not less than 1” high
Same exception for pharmacies with electronic data processing

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Inventory Requirements

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Complete and accurate list of all stock of CS must be done upon receipt of DEA registration and this is considered to be the initial inventory of controlled substances
NOT required to submit copy to DEA
Must be kept on location and readily retrievable
C-II inventory separate from III, IV, V
Biennial inventory required thereafter

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Inventory Requirements CII, CV

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C-II actual count
III, IV and V may be estimated if container is open and originally contained 1000 units or less
Containers over 1000 units must perform actual physical count
Include CS no longer saleable and awaiting destruction

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Inventory Requirements cont

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Code of Federal Regulations requires that the inventory include:
The time the inventory is taken (preferably before opening or after closing)
Controlled Substances
name
strength
dosage form (tablets, capsules, syrup)
quantity
Recommends signature and DEA #

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Ordering CS

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C-I, C-II
DEA Form-222
Initial supply of forms may be ordered with application for new registration using DEA Form-224 (check box #2)
DEA Form-222A is used to reorder the forms

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Ordering CS DEA Form-222

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DEA FORM-222
Seven sets of forms per book
Max of 6 books per registrant
These forms have serial numbers and are strictly controlled
Loss of the forms must be reported to DEA
Change of address requires new forms

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DEA Form-222 cont’d

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RPh must indicate name, size and quantity of each item ordered.
Copies 1 and 2 are submitted to the supplier
Must be complete, legible and no signs of alteration, erasure or change of any description.
Supplier’s may refuse an order for any of these reasons
Upon receipt, RPh must document on copy 3 the actual quantity received and the date received
If refused, supplier must return copies 1 and 2 to the pharmacy (Registrant) and they should be filed with other C-II records
Electronic ordering of C-II substances is now available
The DEA’s CSOS (Controlled Substance Ordering System) allows fast, secure ordering of C-II substances without the need for written copies of DEA Form 222
http://www.deaecom.gov/csosmain.html

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Power of Attorney to Sign Order Forms

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One or more individuals may be authorized to sign DEA Form-222
POA must be signed by same person who signed most recent DEA registration form
POA must be kept with official records
http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_content.htm#p9d

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Ordering Schedule III, IV and V

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For Schedule III, IV and V substances
No special forms required
These substances are ordered from supplier along with regular inventory.
Receipt, invoice or packing slip must be kept and marked as to quantity received and date received.

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Prescription Requirements for CS

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A prescription is an order for medication which is dispensed to or for an ultimate user
A prescription is NOT an order for medication which is dispensed for IMMEDIATE administration to the ultimate user (i.e., med order for inpatient for immediate administration)

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Prescriptions for CS

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Must be dated
Must be signed by prescriber on date issued
Patient’s full name
Patient’s full address
Practitioner’s full name and address
Practitioner’s DEA #
Name, strength, quantity, dosage form, directions for use and number of refills allowed
Must be in ink, typewritten or indelible pencil
May be prepared by anyone designated but MUST be signed by practitioner/registrant
Practitioner/prescriber is responsible for all aspects of Rx

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Who May Issue Rx for CS

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Any Physician, Dentist, Veterinarian, Podiatrist, Mid-Level Practitioner, or other who is:
1. Authorized to prescribe CS in the jurisdiction in which he/she is licensed to practice; and
2. Registered with the DEA or exempted

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DEA Registration Numbers

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Two letters and seven digits
First letter either A, B, F, M or X
A,B (B’s began in late 1986, now exhausted) or F (began in late 2006)
M = Mid-level practitioner
X for practitioners who have been approved for office TX of opiate addicted individuals
Second letter = first letter or registrant’s last name

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DEA Registration Numbers cont

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Seven digits
First six are randomly generated by computer
Last digit is calculated by finding:
Sum of 1st, 3rd and 5th digit,
Plus the sum of 2nd, 4th and 6th digit multiplied by 2
The right-most digit of the total sum from above becomes the last digit of the DEA number
DEA Registration Numbers
Examples
Dr. Jane Dombrowski
BD 1111119
Sum of positions 1,3,5 = 3
Sum of positions 2,4,6 = 3 x 2 = 6
Last digit becomes 6 + 3 = 9
Examples
Dr. James Nelson AJ 2463595
Dr. Martha Madison FM 7654327

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Practitioner Use of Hospital DEA #

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Interns, residents, staff physicians, ML practitioners may use institutional DEA # IF
Acting as agent of institution
Usual course of business
Authorized by state
Verified by hospital (institution)
Internal code must be issued by the institution
List of codes and corresponding practitioners must be maintained by the institution
RPh should verify with hospital if any doubt
Ex. BU 1234563-279

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Exception to Registration

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PHS – Public Health Service
BOP – Bureau of Prisons
Military – Army, Navy, Air Force, Marines
Any Practitioner in PHS, Military or BOP authorized to prescribe, dispense or administer (but NOT procure or purchase) CS in course of duty is not required to register with DEA
Must specify agency and affix service ID to any Rx written (most cases this is the individuals SSN)

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Exception to Registration (community)

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May be filled in community pharmacies
Some exempted practitioners register with the DEA to expedite service to patients
MLP’s only if registered in the state and allowed to write for CS
Any work outside these excepted agencies requires DEA registration by practitioner

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Valid Rx for Controlled Substances

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Must be issued for a legitimate medical purpose by a practitioner acting in the usual course of sound professional practice.
Practitioner is responsible for proper prescribing and dispensing of CS

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Pharmacist’s Corresponding Responsibility

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An order for CS which purports to be a valid Rx, but is NOT issued in the usual course of professional treatment, or for legitimate and authorized research, is NOT a valid Rx.
Any RPh who knowingly dispenses such an Rx, as well as the individual who issued is subject to criminal and/or civil penalties

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Purpose of Issue cont’d

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Prescription for “Office Stock” Rx NOT valid
A prescription may not be issued in order for an individual practitioner to obtain a supply of controlled substances for the purpose of dispensing to his/her patients

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Rx for C-II

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Must be signed/dated by practitioner
No time limit
Pharmacist must determine need vs date
No limit on quantity
No oral orders except bone fide emergency
NO REFILLS
Fax only to expedite filling
RPh must receive and verify original against fax prior to dispensing
Original must be annotated and filed

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Exceptions to Fax Rule for C-II Rx*

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Patient undergoing home infusion pain Tx
Patient in Long Term Care (LTC) facility
Hospice
*Patient must be so noted on Rx by physician or “agent.” May transmit fax to be treated by pharmacy as original document.

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Rx for C-III, IV or V

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Issued by authorized and registered practitioner may be transmitted by:
Phone
Fax
in writing
Refills permitted if authorized by prescriber

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Refills of C-III or C-IV Rx’s

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Maximum of 5 refills within 6 months if authorized by prescriber on original Rx
C-V
Only as authorized on original Rx
Upon refill, RPh initials and quantity must be recorded on back of original rx. If not, full amount will be assumed dispensed.