Ky.gov
 
Kentucky
Board of Pharmacy

Controlled Substances FAQ

The initial inventory shall be taken on the date the pharmacy first engages in dispensing.  After the initial inventory is taken, an inventory must be taken at least every two years, on any date which is within two years of the previous controlled substance inventory. Inventory for newly federally controlled substances must be inventoried on the effective date of the scheduling or rescheduling.  For Kentucky, when a non-controlled drug is moved to a schedule by Kentucky, it must be inventoried within 30 days of the effective date of the scheduling.  Title 21 CFR 1304.11 and KRS 218A.200(7)    ​

No, but it is strongly encouraged.​

When the inventory was taken, as of opening of business or as of close of business and the date (if an audit is done, need a starting day).  CII drugs must be counted.  CIII-V drugs can be estimated if in stock bottles less than 1000.  The DEA strongly encourages the pharmacy to include the name, address and DEA registration of the pharmacy on the controlled substances inventory, along with the signature of the person(s) responsible for the inventory, however, this is not required.  Title 21 CFR 1304.11 and Pharmacist Manual Section VII​​

Yes, a pharmacy may wholesale the controlled substances to the physician as long as the total number of dosage units wholesaled is not greater than 5% of the total number of dosage units of controlled substances dispensed in the previous 12 month period.  The request cannot be written as a prescription with the physician’s office as the patient because a prescription is for a legitimate patient with a legitimate medical need.  Information required:  if the drug is a CII, a DEA 222 form must be used; for CIII-V drugs the pharmacist must make an invoice and record the following information: name, address and DEA registration of the physician; name, address and DEA registration of the supplying pharmacy; drug name, strength, quantity and NDC number/manufacturer, lot number and expiration date; date of the transaction.  This invoice shall be stored with other controlled substances invoices. 902 KAR 55:060 and KRS 218A.200​

Yes, an ambulance service has a medical director who is a physician who is responsible for the drugs on an ambulance.  A pharmacy may wholesale the controlled substances to the ambulance service in care of the medical director as long as the total number of dosage units is not greater than 5% of the total number of dosage units of controlled substances dispensed in the previous 12 month period.  The request cannot be written as a prescription with the physician’s office as the patient because a prescription is for a legitimate patient with a legitimate medical need.  Information required:  if the drug is a CII, a DEA 222 form must be used; for CIII-V drugs the pharmacist must make an invoice and record the following information: name, address and DEA registration of the ambulance service and physician; name, address and DEA registration of the supplying pharmacy; drug name, strength, quantity and NDC number/manufacturer, lot number and expiration date; date of the transaction.  This invoice shall be stored with other controlled substances invoices.902 KAR 55:060 and KRS 218A.200​

No.  A prescriber can use a computer generated prescription or a stamp.902 KAR 55:105 Section 3(3)(b)​​

A prescriber may use a stamp for the drug name, strength, quantity and directions but may not stamp the date, patient name or the prescriber's signature.902 KAR 55:105 Section 3(3)(c)​​

Yes, the prescriber’s name, address and telephone number may be preprinted, stamped, typed or manually printed on the prescription.902 KAR 55:105 Section 3(2)​​

​Yes, as of January 1, 2021, Kentucky law requires the electronic prescribing of controlled substances (EPCS) for all Schedule II–V drugs. This mandate applies to all practitioners in Kentucky, regardless of the payer, and is outlined in Kentucky Revised Statute (KRS) 218A.182. The regulation is enforced through Kentucky Administrative Regulation 902 KAR 55:130.

KRS 218A.182(1) identifies certain prescriptions that are exempt from the electronic prescribing mandate, including a temporary waiver for entities that demonstrate economic hardship, technological limitations, or other exceptional circumstances.

Practitioners unable to comply with the EPCS mandate may request a temporary waiver by submitting a completed Temporary Exemption Form to the Cabinet for Health and Family Services (CHFS). Initial waiver applications were due by November 1, 2020; however, the CHFS continues to accept waiver requests. Waivers are typically granted for one year and may be renewed annually.​​​

​From Drug Enforcement and Professional Practices (DEPP) Branch of the OIG, printed in September 2010 Newsletter:

  • After consulting with the prescribing practitioner, a pharmacist may add or modify the following items:
    1. Date of issue – may be added, but not changed
    2. Drug strength
    3. Quantity – may be modified only in conjunction with a change of strength, and the total quantity dispensed must not exceed the total dosage authorized
    4. Quantity check-off box marked
    5. Directions for use
    6. Refill instructions (Schedules III-V)
    7. Practitioner's name – printed (not a signature)
  • All consultations must be documented. 
  • The following items may be added or modified without consulting the practitioner if the information can be obtained from other reliable sources:
    1. Patient's address
    2. Dosage form
    3. Practitioner's address – printed
    4. Practitioner's telephone number
    5. Practitioner's DEA number
  • A pharmacist may never change or add the patient's name, the name of the controlled substance (except generic substitution permitted by state law), or the signature of the practitioner.

Both state and federal law still require professional judgment by the pharmacist on every prescription filled. Caution is advised whenever a change or addition is made to any prescription.


60 days from the date written  KRS 218A.180​​

KRS 218A.205, limits the prescribing of a Schedule II controlled substance used to treat acute pain to a 3 day supply. The exceptions are: 

  1. In the professional judgment of the practitioner, more than a 3 day supply is needed.  The need must be documented . For the purposes of pharmacy dispensing, the medical necessity for a Schedule II controlled substance as documented by the practitioner in the patient's medical record and the prescription for more than a 3 day supply for that controlled substance are presumed to be valid.
  2. Treating chronic pain.
  3. Treating cancer pain.
  4. Treating a patient at end of life or in Hospice.
  5. Part of a narcotic treatment program.
  6. Treatment of pain after major surgery or significant trauma as defined by the licensing Board and the Office of Drug Control Policy.
  7. Dispensed or administered directly to the patient in an inpatient setting.
  8. Scenarios authorized by the licensing board. 
  9. APRNs must still follow prescribing limits set forth in KRS 314.011.​

​

  1. Other than the 3 day limit for acute pain and the exemptions listed above, MD/DO There is no maximum quantity in state or federal law
  2. Other than the 3 day limit for acute pain and the exemptions listed above, DMD/DDS There is no maximum quantity in state or federal law; however, it should be only of a sufficient amount to treat the patient. KRS 313.035(6)
  3. Other than the 3 day limit for acute pain and the exemptions listed above, DPM There is no maximum quantity in state or federal law. 201 KAR 25:090
  4. Other than the 3 day limit for acute pain and the exemptions listed above, APRN 3 day supply with exceptions for ADD/ADHD drug if certified in mental health 30 days, KRS 314.011(8) and hydrocodone combination products 30 days. KRS 218A.020(3)
  5. Other than the 3 day limit for acute pain and the exemptions listed above, OD 72 hour supply of hydrocodone combination products, KRS 218A.020(3) but no other CII. KRS 320.240(13)
  6. Other than the 3 day limit for acute pain and the exemptions listed above, PA cannot prescribe schedule II controlled substances.​

​

No, when the prescription contains instructions from the physician stating the prescription cannot be filled until a certain date, a pharmacist may not fill the prescription before that date.

 21 CFR 1306.14(e)​​​

Physicians may only prescribe CII amphetamine or amphetamine-like substances to treat:

  • Narcolepsy
  • Attention deficit/hyperactivity disorder
  • Resistant depression disorder in conjunction with antidepressants
  • Drug-induced brain dysfunction
  • Investigational use that has been approved by the Kentucky Board of Medical Licensure
  • May not be used to treat obesity

201 KAR 9:016 Section 3 ​

​

No. 201 KAR 9:260​​

Per KRS 314.011(8),the only Schedule II controlled substance used to treat pain that an APRN may prescribe for greater than a 3 day supply is any hydrocodone combination product. For all other Schedule II controlled substances used to treat pain, KRS 314.011(8) limits the quantity to a 3 day supply with no exceptions.

KRS 218A:205, limits the prescribing of a Schedule II controlled substance used to treat acute pain by all practitioners who are allowed to prescribe Schedule II controlled substances to a 3 day supply. KRS 314.011(8) limits all Schedule II controlled substances with the exception of hydrocodone combination products (and ADD/ADHD medication in specific circumstances) to a 3 day supply. The exceptions for an APRN to prescribe greater than a 3 day supply of HYDROCODONE COMBINATION PRODUCTS ONLY are: 

  1. In the professional judgment of the APRN, more than a 3 day supply is needed.  The need must be documented . For the purposes of pharmacy dispensing, the medical necessity for the hydrocodone combination product as documented by the APRN in the patient's medical record and the prescription for more than a 3 day supply for the hydrocodone combination product are presumed to be valid.
  2. Treating chronic pain.
  3. Treating cancer pain.
  4. Treating a patient at end of life or in Hospice.
  5. Treatment of pain after major surgery or significant trauma as defined by the licensing Board and the Office of Drug Control Policy.
  6. Administered directly to the patient in an inpatient setting. Administered directly to the patient in an inpatient setting.
  7. Scenarios authorized by the licensing board. 

Please note, APRNs must still follow prescribing limits set forth in KRS 314.011.​​

The Kentucky Board of Nursing has provided the following clarification on Suboxone prescriptions: "Under the language of the statute (KRS 314.011 (8)), a single prescription cannot be refillied, and the total number of doses should not exceed the statutory 30-day supply limit." If a nurse practitioner has any further questions, please direct them to the Kentucky Board of Nursing.​

CII – 3 day supply, KRS 314.011(8) with exceptions:

Psychostimulants if APRN is certified in psychiatric-mental health 30 days, KRS 314.011(8) and hydrocodone combination products 30 days. KRS 218A.020(3)

     CIII – 30 day supply no refills. KRS 314.011(8)

     CIV – V – 6 month supply, KRS 314.011(8)

Please note that 201 KAR 20:059, limiting carisoprodol, alprazolam, diazepam, clonazepam, and lorazepam to 30 days with no refills has been repealed and these limitations no longer exist. Updated February 24, 2021.

​

​CII - PA's may not prescribe CII's.
    CIII- 30 day supply no refills, KRS 311.858(5)(c)
    CIV-V - 6 month supply, KRS 311.858(5)(d) with exceptions: Benzodiazepines C IV and Carisoprodol (Soma) C IV. All limited to 30 day supply with no refills. KRS 311.858(5)(e).

Yes, a pharmacist has a corresponding responsibility along with the prescriber to make sure controlled substance prescriptions are written for a legitimate patient, for a legitimate medical need in the usual course of practice of the prescriber. Title 21 CFR 1306.04 KRS 218A.180(3)​​

There are red flags a pharmacist can look for when trying to determine the validity of a prescription.  This list is not inclusive and does not take the place of a pharmacist's professional judgment. 

  • Does the pharmacist have a relationship with the prescriber?
  • Does the pharmacist have a relationship with the patient?
  • What is the distance a patient is driving to see the prescriber?
  • What is the home address of the patient?
  • In what community is the prescriber practicing?
  • Have people unknown to the pharmacist called asking if a specific medication or a specific manufacturer of a medication is stocked by the pharmacy?
  • When prescriptions are filled for one patient, do many, many more start coming to the pharmacy?
  •  Is every patient receiving the exact same prescriptions?
  • Does the prescriber take cash only? ​

​

​902 KAR 55:095 and 21 CFR 1306.13​

1. Insufficient Stock: If a pharmacist cannot supply the full quantity of a CII prescription due to insufficient stock, they may dispense the available quantity. The remaining portion must be filled within 72 hours. If not, the pharmacist must notify the prescribing practitioner, and no further quantity may be supplied without a new prescription.​

2. Patient or Practitioner Request: A CII prescription may be partially filled if requested by the patient, the patient's caregiver (if the patient is a minor), or the prescribing practitioner. The total quantity dispensed in all partial fillings must not exceed the total quantity prescribed.

3. Terminally Ill Patient: When the patient is terminally ill (for example in Hospice) and it is documented on the face of the prescription, the pharmacist has 60 days to dispense the full quantity of the prescription.

4. Long-Term Care Resident: When the patient is in a long term care facility, the pharmacist has 60 days to dispense the full quantity of the prescription. ​

5. Time Limitations: For partial fillings requested by the patient or practitioner, the remaining portions must be filled within 30 days of the prescription's issuance date.

6. Documentation Requirements: Each partial fill must be documented appropriately. This includes noting the quantity dispensed, the date of dispensing, and the identity of the dispensing pharmacist​.

​One time only, unless pharmacies electronically share a real-time, online database, then may transfer as many times as there are refills. Title 21 CFR 1306.25

No, a controlled substance prescription must be transferred between two pharmacists or via a real-time, online database. Title 21 CFR 1306.25​​​

No, a controlled substance prescription must be transferred between two pharmacists or via a real-time, online database. Title 21 CFR 1306.25​​​

​In general, no. The pharmacy can choose to require it. Also, the DEA's Expansion of Buprenorphine Treatment via Telemedicine Encounter was scheduled to be effective February 18, 2025 but has been delayed to December 31, 2025. Notably, this delayed final rule will require pharmacists filling buprenorphine telemedicine prescriptions to verify that the identity of the individual picking up the prescription matches the name of the patient or a member of the patient’s household.​​

No​

201 KAR 2:205(3)(g) requires a pharmacy to report any theft or loss to: “1. The U. S. Department of Justice Drug Enforcement Agency as required by 21 C.F.R. 1301.76(b); 2. The Department of the Kentucky State Police as required by KRS 315.335; and 3. The board by providing a copy to the board of each report submitted."

KRS 315.335 

KRS 218A.200(6) a copy of the detailed list of controlled substances lost, destroyed, or stolen shall be forwarded to Cabinet for Health and Family Services as soon as practical.

Please send a copy of your DEA 106 or other reporting form for the loss/theft to:
CHFS: eKASPER.ADMIN@ky.govor fax to 502-564-7568
BOP: pharmacy.board@ky.govor fax to 502-696-3806​

​

    Back to Top

    ​​​​​​​​​​​