Lec. 1 Controlled Substances Flashcards
Federal Regulations: The Drug Enforcement
Administration (DEA) - general information
- Established in 1973 to serve as the primary agency responsible
for enforcement of federal drug laws
—– To prevent diversion and abuse of controlled substances…
—– While ensuring an adequate and uninterrupted supply is available
to meet the country’s legitimate medical, scientific, and research needs
Fed Reg. Schedules of Controlled Substances - schedule I - V general description
1.) Schedule I
—- High potential for abuse, no currently accepted medical use in the US
2.) Schedule II
—- High potential for abuse, may lead to severe psychological or physical
dependence
3.) Schedule III
—- Potential for abuse less than substances in I or II and abuse may lead to moderate or low physical dependence or high psychological dependence
4.) Schedule IV
—- Low potential for abuse relative to substances in schedule III
5.) Schedule V
—- Low potential for abuse relative to substances listed in schedule IV and
consist primarily of preparations containing limited quantities of certain
narcotics
Fed Reg: Section 3- Registration Requirements (part 1)
1.) New pharmacy registration
—- In addition to a state controlled substances license, every
pharmacy that dispenses a controlled substance must be registered with the DEA (need for every single location!! every pharmacies’/ must be reg with DEA)… Separate registration for each location
2.) DEA Form 224 -> Online, Renewal every 3 years (224a, No more than 60 days prior to current expiration date, 224b (Retail Pharmacy Registration Affidavit for Chain Renewal))
3.) Duplicate Certificate of Registration – DEA Form 223
Fed Reg: Section 3- Registration Requirements (part 2) transfer of business
Transfer of business
- Submitted at least 14 days in advance
- Complete inventory must be taken on day of CS transfer and copy must be included in records of both
- Use DEA Form 222 to transfer schedule II drugs (form cannot be toss or shredded! must be returned to DEA!)
- Records don’t need to be sent unless requested
Fed Reg: Section 3- Registration Requirements (part 3)
Change of business address
- Modification of registration
- Proper state license, if change in state, prior to
- Maintain new certificate with old one until expiration
.
Registration termination
- Return certificate and any unused DEA 222 forms
- Controlled substance records need to be kept for at least 2 years
- Dispose of unwanted controlled substances in accordance with DEA regulations
Fed Reg: Section 3- Registration Requirements (part 4)
- DEA can deny, suspend or revoke registration
- Denial of registration in public interest
—- State recommendation
—- Experience or conviction record of applicant
—- Compliance with laws
—- Conduct that may threaten public health and safety
Fed Reg: Section IV – Transfer or Disposal of Controlled Substances: Transfer of controlled substances
- Can transfer to another pharmacy or to original supplier/manufacturer
- Pharmacy may hire outside firm to arrange transfer; pharmacy is ultimately responsible
- Records kept for 2 years
- Receiving registrant must issue DEA Form 222 (Controlled substances III‐V must document dosage, strength, quantity and date of transfer)
Fed Reg: Section IV – Transfer or Disposal of Controlled Substances: Disposal of controlled substances
DEA registered reverse distributor
- Local DEA office for current list
- DEA Form 222 – record of destruction for schedule II
- III‐V – pharmacy maintains record of distribution with drug name,
dosage form, strength, quantity and date transferred
- DEA Form 41 (Registrants Inventory of Drugs Surrendered) – reverse
distributor submits to DEA when drugs destroyed
Fed Reg: Section V - Security Requirements
- Shall provide effective controls and procedures to guard against theft and diversion
- The registrant shall not employ, as an agent or employee who has access to controlled substances, any person who has been convicted of a felony offense relating to controlled substances or who, at any time, had an application for registration with the DEA denied, had a DEA registration
revoked or has surrendered a DEA registration for cause (Waiver from DEA to employ an individual who meets this definition) - Notify the DEA Field Division Office and local police of theft or significant loss within one business day of discovery, in writing (DEA Form 106!!! If investigation finds no theft or loss, no need to complete DEA Form 106 but must report to DEA why not filed)
.
NOTE: significant - no definition… defined by the individual pharmacy and the stock/ amount they have!! a lots of med in stock? we loss a bottle? not a significant amount… play by ear.
Fed Reg: Section V – Security Requirements: Theft or significant loss
Registrants responsibility to identify significant loss
- Quantity in relation to type of business
- Specific controlled substance
- Pattern of loss over a period of time
- Control substance likely for diversion
- Local trends of diversion potential
Fed Reg: Section V - Security Requirements: in-transit loss, breakage/ spill, robbery
1.) In‐transit loss from central fill pharmacy
- Pharmacy is responsible not the carrier
- Purchaser completes DEA Form 106
.
2.) Breakage/spillage
- Dispose accordingly
- DEA Form 41
.
3.) Robbery
- Potential for federal investigation
- Penalties upon conviction (Below!)
- Max $25,000 fine and/or 20 years imprisonment
- If dangerous weapon used, max $35,000 and/or 25 years
imprisonment
- If death resulted, max $50,000 and/or life imprisonment
Fed Reg: Section VI - Record Keeping ( v important!)
- Complete and accurate records
- Maintained for at least 2 years
- Separate CII from CIII‐V
- Must be readily retrievable
- Can be filed electronically or in paper form
——- If conflict between federal and state requirements for filing
prescriptions, the DEA recognizes that the pharmacy must choose a filing system that would comply with both federal and state law
Fed reg: Section VI - Record Keeping: Required records which must be maintained:
Fed Reg: Section VII – Inventory Requirements
1.) Initial inventory
- Date
- Whether inventory was taken at beginning or close of business
- Name of the controlled substance inventoried
- Finished form of each substance (e.g. 10mg tablet)
- Number of dosage units of each finished form in the commercial container (e.g. 100 tablet bottle)
- Number of commercial containers of each finished form (e.g. four
100 tablet bottles)
- Count of the controlled substance – exact if schedule II, estimate for
schedule III, IV or V unless container holds more than 1000 tabs or capsules, then exact count required
2.) Biennial inventory (every other year)
- Same process as initial
3.) Newly scheduled controlled substance inventory
- Inventoried on effective date
Fed Reg: Section VIII – Ordering Controlled Substances
1.) DEA Form 222
- Schedules I and II
- Number of packages
- Size of the package
- Name of the controlled substance
- Must be signed by authorized person
- Pharmacist must document date and actual number of packages received
- File once complete
.
2.) Lost or stolen forms
- Must be reported to the local DEA office immediately
- Must provide serial numbers of each lost/stolen form, or the
approximate date of issue
.
3.) Schedules III‐V
- Registrant must keep a receipt (invoice or packing slip) that contains the name of each controlled substance, form, number of dosage units in each container, and the number of commercial containers ordered and received
—– Record date of receipt
—– Confirm accurate order
—– Readily retrievable
Fed Reg: Section IX – Valid Prescription Requirements: Prescription
- Dated and signed on the date when issued
- Patient’s full name and address, and the practitioner’s full name, address and DEA registration number
- Drug name
- Strength
- Dosage form
- Quantity prescribed
- Directions for use
- Number of refills authorized (if any)
Fed Reg: Section IX – Valid Prescription Requirements: Who may issue..
A prescription for a controlled substance may only be issued by a physician, dentist, podiatrist, veterinarian, mid‐level provider, or other registered practitioner who is:
- Authorized to prescribe controlled substance by the jurisdiction
in which the practitioner is licensed to practice, AND - Registered with DEA or exempted from registration (e.g. Public
Health Service, Federal Bureau of Prisons, military practitioners),
OR - 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, provided that additional requirements as set forth in the C.F.R. are met
Fed Reg: Section IX – Valid Prescription Requirements (other)
- Issued for legitimate medical purpose by practitioner acting in the usual course of professional practice
- Pharmacist is required to exercise sound professional judgement when making a determination about the legitimacy of a controlled substance prescription
- Pharmacist must verify practitioner and valid DEA number
Fed Reg: Section IX – Valid Prescription Requirements: Hospital prescriber DEA number
- Practitioners (e.g. intern, resident, staff physician, mid‐level
practitioner) who are agents or employees of a hospital or other
institution - Current list of internal codes and corresponding individual
practitioners is to be maintained by hospital or institution (Example: AB1234567‐012) - Pharmacist to contact hospital for verification if needed
DEA Number Validation… Is this a valid DEA number? How do you check?
BF6428522
- Add together the 1st, 3rd and 5th digits.
- Add together the 2nd, 4th and 6th digits. Double it.
- Add the two totals together.
- The second digit in that total is the check digit
.
THIS IS NOT VALID!!! (Lc)
Section IX – Valid Prescription Requirements: Schedule II substances require a written prescription
- Manually signed or meets all DEA requirements for electronic prescriptions
- While some states and many insurance carriers limit the quantity of controlled substances dispensed to a 30‐day supply, there are no express federal limits with respect to the quantities of drugs dispensed via a prescription
- Amount dispensed must be consistent with requirement that the
controlled substance be issued only for a legitimate medical purpose by a practitioner acting in the usual course of professional practice - Refills prohibited
Fed Reg: Section IX – Valid Prescription Requirements…
- Practitioner can write 90‐day supply of CII if separate prescriptions are used
- Must comply with laws
- Must ensure it is for medical use
- Must indicate earliest date of fill
Fed Reg: Section IX – Valid Prescription
Requirements: Can fax CII if original prescription is available at pick‐up unless:
- Long‐term care
- Hospice care
- Compound for direct administration
Fed Reg: Section IX – Valid Prescription Requirements…
- Schedule III‐V
- Call in, fax, electronic
- Refilled up to 5 times within 6 months after the date of issue
- When controlled substance III or IV is refilled must include
….. Dispensing pharmacist’s initials
….. Date the prescription was refilled
….. Amount of drug dispensed on the refill
Fed Reg: Section IX – Valid Prescription Requirements: Transfer of scheduled III‐V?
- Can transfer between pharmacies once
- If pharmacy is part of the same system, can transfer between
pharmacies as long as the prescription is valid
.
Prescription monitoring program can help regulate
Fed Reg: Section X – Dispensing Requirements Prescription label must contain:
- CAUTION: Federal law prohibits the transfer of this drug to any
person other than the patient for whom it was prescribed
Fed Reg: Section X – Dispensing Requirements: Emergency dispensing
Emergency dispensing
- Immediate administration of the drug is necessary for proper
treatment of the intended ultimate user
- Not possible for the prescribing practitioner to provide a written
prescription for the drug at that time
- Prescriber may call in a CII provided that
—– A written and signed prescription is provided to the pharmacy within
7 days
—— The amount is limited to what is needed to treat the patient during
the emergency period
—— The prescription is immediately reduced to writing by the pharmacist
Fed Reg: Section X – Dispensing Requirements: Partial dispensing of CIIs
Fed Reg: Section X – Dispensing Requirements: Partial dispensing of CIII‐V
Allowable with documentation of each partial fill; cannot dispense
beyond 6 months from the date prescription was issued
Fed Reg: Section XII – Other Pharmacy Options: Central Fill Pharmacy
- When one retail pharmacy receives a prescription and a second
pharmacy prepares and subsequently delivers the controlled
substance medication to the first retail pharmacy for dispensing
to the patient - Both required to maintain records
- Prescriptions for controlled substances listed in II‐V may be
transmitted electronically from a retail pharmacy to a central fill
pharmacy including via facsimile
Fed Reg: Section XII – Other Pharmacy Options: Central fill pharmacy
* The retail pharmacy transmitting the prescription information must:
- Write the word “CENTRAL FILL” on the face of the original
prescription and record the name, address and DEA registration of
the central fill pharmacy to which the prescription has been
transmitted and the name of the retail pharmacy pharmacist
transmitting the prescription and date of transmittal; - Ensure all information required to be on a prescription is transmitted
to the central fill pharmacy; - Maintain the original prescription for a period of 2 years from the
date the prescription was last refilled; - Keep a record of receipt of the filled prescription, including the date
of receipt, the method of delivery and the name of the retail
pharmacy employee accepting delivery; - For scheduled III‐V, indicate in the information transmitted the
number of refills already dispensed and the number of refills
remaining - Keep a copy of the prescription (if sent via facsimile) or an electronic
record of all the information transmitted by the retail pharmacy,
including the name, address and the DEA registration number of the
retail pharmacy transmitting the prescription; - Keep a record of the date of receipt of the transmitted prescription,
the name of the licensed pharmacist filling the prescription, and
dates of filling or refilling of the prescription; and - Keep a record of the date the filled prescription was delivered to the
retail pharmacy and the method of delivery
Fed Reg: Section XII – Use of Automated Dispensing Systems by Retail Pharmacies at Long Term Care Facilities
- If state law permits, the DEA will allow a retail pharmacy to
register at the site of the LTCF and store controlled substances
in the Automated Dispensing System (ADS) as outlined in 21
C.F.R. 1301.27 - Pharmacy programs and controls the ADS remotely
- Only authorized LTCF staff are allowed access to its contents,
which are dispensed on a single‐dose basis at the time of
administration pursuant to a valid prescription
Fed Reg: Section XIV – Combat Methamphetamine Act of 2005
- Requirements for retail sales of over‐the‐counter products
containing ephedrine, pseudoephedrine, and phenylpropanolamine - Product behind counters, locked cabinets
- Check purchaser identity and log information
- Maintain log for 2 years
- 3.6 grams/day max
- 9 grams/month max
NM/State Reg: 16.19.20.8 – Registration Requirements
- Manufacturer, distributer, dispenser, practitioner, investigator,
analytical and chemical analysis laboratories, teaching institutes - Practitioner can be under hospital or clinic
- Same as federal regulation
NM Reg: 16.19.20.13 – Separate Registration of Each Place of Business
- Required for each principal place of business or professional
practice with the address indicated on the application if drugs
are dispensed or distributed from different locations - This does not include warehouse storage areas; office used by
agents for soliciting which contain no controlled substances
other than samples, physician’s office where controlled
substance are prescribed but not administered or otherwise
dispensed
NM Reg: 16.19.20.19 – Modification, Transfer and Termination of Registration
- Modification of a registration to authorize additional
controlled substances may be made by filing an application in
the same number as an application for a new registration - Registration shall terminate if and when a registrant dies,
discontinues business or professional practice, has his/her
professional license revoked or suspended, no longer
possesses a DEA registration and/or has had his/her DEA
registration revoked or suspended or changes his/her name or
address as shown on the registration (Notify BOP within 30 days)
NM Reg: 16.19.20.20 – Inventory Records
NM Reg: 16.19.20.25 – Controlled Substances Inventories and Records
- Pharmacies, hospitals, clinics and practitioners who dispense
controlled substances shall maintain inventories and records
of controlled substances listed in Schedules II and II‐N
separately from all other prescription records - “readily retrievable” means records kept in such a manner as
to be easily separated out from all other records in a
reasonable time or records are kept on which certain items
are redlined, starred or in some manner are visually
identifiable apart from other items appearing on the record
NM Reg: 16.19.20.31 - Pharmacy and Hospital Prescription and Dispensing Records
- CIIs maintained in a separate file
- In pharmacies without computerized prescription information,
CII‐V shall have the name of the dispensing pharmacist and
the date filled inscribed on the face of the prescription - CIII‐V maintained either in separate file only or in such form
that they are readily retrievable
NM Reg: 16.19.20.31 - Pharmacy and Hospital Prescription and Dispensing Records
NM Reg: 16.19.20.36 – Report of Loss or Theft of a Controlled Substance
The registered supplier shall be responsible for reporting in‐
transit losses of controlled substances by a common carrier or
contract carrier selected by the supplier upon discovery of
such loss or theft.
—–Complete DEA Form 106 as required and furnish a copy to the
BOP
.
A significant loss or theft of a controlled substance shall be
reported in writing to the BOP and DEA on Form 106 as
required by federal regulation
—— “significant loss” includes suspected diversions, in‐transit losses
or any other unexplained loss and must be reported to the BOP
within 5 days of becoming aware of the loss
NM Reg: 16.19.20.37 – Hospitals, Institutions, Clinics
- Disposal of excess or undesirable controlled substances
resulting from extemporaneous amounts of residue or wasted
controlled substances - A registrant who needs to dispose of excess or undesirable
controlled substances resulting from injections from ampules
or less than the full ampule or other such circumstances shall
keep a written memorandum report on the hospital narcotic
records and periodically file a report on DEA Form 41 with DEA
pursuant to the requirements of the federal regulations
NM Reg: 16.19.20.41 – Prescriptions
- Controlled substance used for a legitimate medical purpose
- May not be used for supplying practitioner for the purpose of
general dispensing to patients - May not be used for dispensing to narcotic‐dependent person
for sole purpose of continuing dependence upon such drugs
NM Reg: 16.19.20.42 – Prescription Requirements
All prescriptions for controlled substances shall be dated as of,
and signed on, the day when issued and shall bear the
following:
— Full name and address of the patient
— Drug name, strength, dosage form, quantity prescribed,
directions for use
— Name, address and registration number of the practitioner
NM Reg: 16.19.20.42 Electronic Controlled Substance Prescriptions in NM
Effective April 1, 2021 all controlled substance prescriptions must be electronically transmitted, except:
- Intermediate care, skilled nursing, correctional facility
- Enrolled in hospice
- For animal by licensed veterinarian
- Dispensed by federal facility not subject to state regulation (e.g., VA, HIS)
- Requires information that makes impractical (e.g., lengthy directions, new medication not in system)
- Compounded prescriptions
- Issued in an emergency pursuant to federal law and rules of Board of Pharmacy
NM Reg: 16.19.20.46 – Partially Refilled
- A CII may be partially filled if the total quantity dispensed in all
partial fillings does not exceed the total quantity prescribed.
Remaining portions shall be filled not later than 30 days after
the date which the prescription was written (CARA 2016) - Partial filling of a prescription for CIII or IV shall be recorded in
the same manner as a refill, providing the total quantity of
partial filling does not exceed the total quantity prescribed
and no dispensing occurs after 6 months from date of
prescription
NM Reg: 16.19.20.47 – Emergency Dispensing
“Emergency situation” means the prescribing physician determines:
- The immediate administration of a controlled substance is
necessary for proper treatment of the intended patient; - That no appropriate alternative treatment is available, including
administration of a drug which is not a controlled substance
under Schedule II; AND - That it is not reasonably possible for the prescribing practitioner
to provide a written prescription to be presented to the person
dispensing the substance prior to the dispensing
NM Reg: 16.19.20.47 – Emergency Dispensing
A pharmacy may dispense a Schedule II controlled substance in the
above instance only if he receives oral authorization of a practitioner
or authorization via facsimile machine and provided:
- The quantity prescribed is limited to the amount needed to treat the
patient during the emergency period; - The pharmacist shall reduce the prescription to a written form and it
contains all information required of a CII except the signature of the
prescribing practitioner; - The prescribing physician, within 7 days after authorization of the
emergency dispensing, shall furnish a written, signed prescription to
the pharmacist. The signed prescription shall have written on the
face “AUTHORIZATION FOR EMERGENCY DISPENSING” and the date
of the oral or facsimile order; - The signed prescription shall be attached to the oral emergency
prescription order or the facsimile emergency prescription order and
be filed as other CII prescriptions - In the event the prescribing physician fails to deliver a signed written
prescription to the pharmacist within the 7 day period, the
pharmacist shall notify the nearest DEA office and the BOP
NM Reg: 16.19.20.48 – Security
Applicants and registrants shall provide effective controls and
procedures to guard against theft
- Location
- Types of controlled substances
- Quantity handled
- Type of vault, safe and secure enclosures
- Adequacy of key control systems and/or lock control system
- Extent of unsupervised public access to facility
- Adequacy of supervision over employees having access to storage
or distribution areas - Procedures for handling business guests, visitors, maintenance
personnel and non‐employee service
NM Reg: 16.19.20.58 – Voluntary Consent to Inspection
The Board inspector will ask the registrant to voluntarily
consent to the inspection. He will inform the registrant of his
constitutional rights to an inspection warrant, however, if the
registrant consents to inspection without warrant, the
inspector will obtain a signed consent waiver statement from
the registrant before proceeding with an accountability audit
or inspection
NM Reg: 16.19.21.3 – Statutory Authority
Pursuant to 30‐31B‐6 of the Drug Precursor Act, 30‐31B‐1
through 30‐31‐B‐18 NMSA 1978, the BOP may promulgate
regulations and charge reasonable fees relating to the
licensing and control of the manufacture, possession, transfer
and transportation of drug precursors. Section 30‐31B‐4
NMSA 1978 authorizes the Board to add substances to the list
of precursors enumerated in the Drug Precursor Act
NM Reg: 16.19.29.8 – Mandatory Reporting to PMP
- The board shall monitor the dispensing of all Schedule II‐V controlled substances by all dispensers licensed to dispense
- Each dispenser shall submit to the board by electronic means information regarding each prescription dispensed for a drug
- Each dispenser shall submit the information in accordance with transmission methods and frequency established by the board; but shall report at least within one (1) business day of the prescription being filled
NM Reg: 16.19.4.16 E‐ Prescription Monitoring Program (PMP)
NM Reg: 16.19.29.9 – Disclosure of Prescription Information
- The board shall maintain procedures to ensure that the
privacy and confidentiality of patients and patient information
collected, recorded, transmitted, and maintained is not
disclosed to persons - After receiving a complaint, the board inspectors shall review
the relevant prescription information - If there is reasonable cause to believe a violation of law or
breach of professional standards may have occurred, the
board shall notify the appropriate law enforcement or
professional licensing, certification or regulatory agency or
entity, and provide prescription information required for an
investigation
Buprenorphine-New Federal Update
X‐waiver no longer required to prescribe as long as you have a DEA license to prescribe CIIIs (effective 1/13/2023)
