Prescription records must be kept for five years. An original prescription and record of each refill, if received written or oral, should be kept as a hard copy for three years, at which point it must be kept for at least an additional two years in either hard copy form or electronically. An original prescription and record of each refill, if received via fax, may be kept in hard copy form, the original electronic image, or electronically for three years, at which point it must be kept for at least an additional two years in either hard copy form, the original electronic image, or electronically. An original prescription and record of each refill, if e-prescribed, should be kept electronically for at least five years.
A record of the day's prescription data should be verified, dated, and signed by the pharmacist(s) who filled the prescriptions. This record must be kept for at least 5 years and can be done electronically, manually, or in a log. The record should be readily retrievable. Controlled substance data should be identifiable apart from other items appearing in the record. Note: These are the state requirements, insurance contracts and Medicare may have more stringent requirements.
201 KAR 2:171
Controlled
substance inventory records including invoices must be kept for five
years. KRS 218A.200
Permission
to store records off-site must be requested and approved by the Board; requests
should describe detailed storage conditions and security.
A pharmacy is allowed to wholesale distribute prescription medications in a limited quantity, not to exceed 5% of the total inventory. These transactions must be documented in an invoice, similar to what the pharmacy receives from their wholesale distributer. Information to be documented includes the recipient, date, quantity, itemized description and any other information pertinent to the transaction. Please file transaction information with other invoices. KRS 315.400
Immediately following the robbery or discovery of the theft, report the incident to a law enforcement agency serving the geographic area in which the pharmacy is located. If a pharmacy has mailed or shipped a controlled substance to a location in Kentucky and learns that the mailing or shipment did not arrive, that pharmacy shall report the nonreceipt to the Kentucky State Police and, if applicable, the US Postal Inspection Service. The PIC should file reports with the following: DEA via Form 106; the Drug Enforcement and Professional Practices Branch and the Board of Pharmacy shall receive a copy of the completed DEA Form 106. KRS 315.335
Pursuant to prescriber approved protocols a pharmacist may administer:
- Adult immunizations
- Immunizations to individuals five (5) to seventeen (17) years old with the consent of a parent or guardian
KRS 315.010
Yes, the practice of pharmacy definition includes the administration of medications or biologics in the course of dispensing or maintaining a prescription drug order. Note: A pharmacist may want to check with his or her malpractice insurance provider to see if this act is covered. KRS 315.010
What an intern may do is up to the supervising pharmacist's discretion as long as the intern has successfully completed his or her first professional year coursework of a Doctor of Pharmacy degree program at an accredited school or college of pharmacy. Note: Due to federal regulations an intern cannot transfer a controlled substance prescription. 201 KAR 2:095
Anyone who assists in the practice of pharmacy must be registered with the Board of Pharmacy as a technician. Examples of assisting in the practice of pharmacy include: offering pharmacist counseling at pickup, processing prescriptions, preparing compounds, and counting medications. KRS 315.010
The
National Institute for Occupational Safety and Health (NIOSH) publishes a List
of Antioneoplastic and Other Hazardous Drugs in Healthcare Settings.
In order for a pharmacist to substitute a generic drug for a brand name drug, Kentucky requires the generic drug to be AB rated to the brand name drug per the FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. If the prescription is written for a brand name drug and the generic drug is not AB rated, in order for the pharmacist to dispense the generic, he must call the prescriber to obtain authorization for substitution. An Authorized Generic Drug is not the same as an AB rated generic drug (see next question). An example is that there is no AB rated generic for Epipen, therefore, the pharmacist must contact the prescriber prior to dispensing the generic epinephrine injection.KRS 217.822
Yes, with one exemption. Per KRS 218A.202(2), all pharmacists authorized to dispense controlled substances must register and maintain a KASPER (Kentucky All Schedule Prescription Electronic Reporting) account.
The exemption for not obtaining a KASPER account is if the place of employment does not have a DEA registration. Examples would include a pharmacist employed at a non-dispensing pharmacy; working as a consultant pharmacist; employed in industry, academia or government; or not currently employed as a pharmacist. If the pharmacy has a DEA registration, including hospital and long term care pharmacies, the pharmacist must obtain and maintain a KASPER account.
A Kentucky licensed pharmacist employed by an out of state pharmacy that has a DEA registration, including hospital and long term care pharmacies, must register and maintain a KASPER account.
Kentucky
pharmacy law does not require mandatory use of KASPER by a pharmacist. It is
the professional discretion of the pharmacist to determine appropriate use of
the system. Pharmacist use of KASPER may be beneficial in determining the
legitimacy of a prescription and fulfilling corresponding
responsibility.
Yes, the patient's SSN shall be obtained, regardless of the patient's age, exceptions:
- Patient doesn't have a SSN, use a driver's license number
- Patient doesn't have a SSN or a driver's license, use all 000-00-0000
- Patient is an animal, use all 000-00-0000
902 KAR 55:110, Section 5
Yes, please contact the KASPER office at 502-564-7985 Monday through Friday 8 am – 4:30 pm to correct the issue.
Yes,
a pharmacist who obtains a KASPER report for the purposes of providing
pharmaceutical treatment to a bona fide current or prospective patient may
share that report with the patient or person authorized to act of the patient's
behalf. KRS
218A.202[7][e] and [9][e]
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.
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
A temporary closure means a pharmacy whose hours of operation have deviated over a period of two (2) consecutive days, five (5) aggregate working days within a fourteen (14) day period or nine (9) aggregate working days within a thirty (30) day period from those of record at the Board of Pharmacy office for a reason other than a federal holiday, permanent voluntary closure or involuntary closure.
201 KAR 2:106
- Update pharmacy hours via Licensure Gateway Portal to ensure pharmacy hours are accurately reflected on License Verification.
- A pharmacy permit holder shall immediately notify the Board of Pharmacy in writing of the following: a. reason for the closure, the anticipated date of reopening, and the plan to provide emergency patient assistance and access to medication throughout the period of closure. b. arrangements necessary to provide adequate and continued security and control of all prescription drugs and drug-related devices and records maintained by the licensee or permit holder.
- At the time the pharmacy permit holder notifies the Board of Pharmacy of the temporary closure, the pharmacy shall place patient-facing signage on all pharmacy entrances and drive through windows providing up to date notification of the closure. The signage shall include notification of the closest, open pharmacy, regardless of ownership, that can assist patients immediately as well as anticipated date and time of reopening.
- The pharmacy permit holder shall update their phone message to include notice of the closure, and if the pharmacy has a website, the website shall also indicate the closure. The phone message and the website shall include a method to speak with an on-call pharmacist during regular operating hours on file with the Board of Pharmacy.
- The pharmacy permit holder shall have a pharmacist onsite or remotely if a common database is utilized and readily available during the posted pharmacy hours for the purpose of transferring prescription record(s) or reversing adjudicated claim(s) to a third-party payer during the time of the temporary closure.
- The pharmacy permit holder shall make a reasonable effort to notify prescribers of the temporary closure and time and date of anticipated reopening.
201 KAR 2:106
An
Automated Data Processing System in a pharmacy is the computer software and
hardware that the pharmacy uses for the purpose of prescription processing and
record keeping.
201 KAR 2:171 Computerized Record Keeping
201 KAR 2:171 Section 1 (9) An auxiliary recordkeeping system shall be established for the documentation of refills if the automated data processing system is inoperative for any reason. The auxiliary system shall ensure that all refills are authorized by the original prescription order and that the maximum number of refills is not exceeded. If the automated data processing system is restored to operation, the information regarding prescriptions filled and refilled during the inoperative period shall be entered into the automated data processing system within seventy-two (72) hours.
The
PIC of a Medical Gas Permit is required to perform quarterly inspections of the
permitted facility. The inspection shall include a review of the permit’s
records, sanitation, and security and control. 201 KAR 2:225
If
a licensee or permit holder wants to change location
a change of address form needs to be submitted to the Board via the Licensure Gateway. Once the
application is processed the permit holder will need to contact the inspector
for the area. The new location will be inspected and approved prior to
authorizing the change in address. Disciplinary action may result in relocation
without proper notification and authorization.
"Manufacturer" means any person, except a pharmacist compounding in the normal course of professional practice, within the Commonwealth engaged in the commercial production, preparation, propagation, compounding, conversion, or processing of a drug, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical synthesis, or both, and includes any packaging or repackaging of a drug or the labeling or relabeling of its container. Any business engaged in these activities within the Commonwealth is required to be permitted by the Kentucky Board of Pharmacy. KRS 315.010
Any pharmacist licensed by the Kentucky Board of Pharmacy may act as PIC of a Manufacturer Permit. The PIC of a Manufacturer Permit may act as PIC of multiple locations.
The
PIC of a Manufacturer Permit is required to perform quarterly inspections of
the permitted facility. The inspection shall include a review of the permit’s
records, and security and control. 201 KAR 2:320
No, only in-state manufacturers are required to obtain a manufacturer permit. An out-of-state manufacturer shipping drugs into Kentucky may be required to obtain a wholesale distributor permit.
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:
- Date of issue – may be added, but not changed
- Drug strength
- Quantity – may be modified only in conjunction with a change of strength, and the total quantity dispensed must not exceed the total dosage authorized
- Quantity check-off box marked
- Directions for use
- Refill instructions (Schedules III-V)
- 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:
- Patient's address
- Dosage form
- Practitioner's address – printed
- Practitioner's telephone number
- 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.
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:
- 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.
- Treating chronic pain.
- Treating cancer pain.
- Treating a patient at end of life or in Hospice.
- Part of a narcotic treatment program.
- Treatment of pain after major surgery or significant trauma as defined by the licensing Board and the Office of Drug Control Policy.
- Dispensed or administered directly to the patient in an inpatient setting.
- Scenarios authorized by the licensing board.
- APRNs must still follow prescribing limits set forth in KRS 314.011.
- 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
- 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)
- 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
- 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)
- 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)
- 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
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:
- 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.
- Treating chronic pain.
- Treating cancer pain.
- Treating a patient at end of life or in Hospice.
- Treatment of pain after major surgery or significant trauma as defined by the licensing Board and the Office of Drug Control Policy.
- Administered directly to the patient in an inpatient setting. Administered directly to the patient in an inpatient setting.
- 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).
APRN
and PA controlled substance prescribing varies from state to state. Kentucky
pharmacists should only dispense a controlled substance prescription for an out
of state APRN and PA up to the authority they would have if it were
a Kentucky APRN or PA.
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
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
DSCSA is a federal law enacted in 2013 that addresses the distribution of most prescription drugs from the manufacturer to the dispenser (ie, the pharmacy). The law is intended to protect the public from potentially counterfeit, stolen, or contaminated drugs. By November 2023, the law requires the identification and traceability of prescription drugs down to the package level.
DSCSA does not apply to over the counter drugs and animal drugs. Additionally, several types of drugs are exempted from the definition of transaction and do not have the same traceability requirements. Those exempted drugs include active pharmaceutical ingredients (API), imaging drugs, certain intravenous fluids, medical gases, radioactive drugs and compounded drugs from outsourcing facilities.
Currently, a pharmacy is required to:
- Confirm that your trading partners are appropriately licensed or registered
- Receive and maintain product tracing documentation*
- Identify, investigate, and report suspect and illegitimate products
*As of November 27, 2023, the product tracing will change from provided transaction documentation to an interoperable electronic exchange.
Pharmacists can verify that manufacturers and repackagers are registered with the FDA on their website.
Wholesale distributors and third party logistics providers (3PL) servicing Kentucky pharmacies must be licensed with the Board of Pharmacy. That license can be verified on the board's website. Keep in mind that the Board's website lists the names of entities' parent companies, which may differ from the names that companies “do business as."
No, Kentucky does not require
wholesale distributors to obtain Drug Distributor
Accreditation.
Beginning November
27, 2023, dispensers are required to use secure,
interoperable, electronic
approaches to track and trace purchased products. Dispensers will work with
their trading partners to select an interoperable electronic system. Pharmacies
must be able to use this system to exchange transaction information for receipt
and returns, to verify products at the package level, and provide transaction
information for a product in the event of an investigation into suspect or
illegitimate products.
FDA has issued draft guidance on the standards for the interoperable exchange. Organizations such as NABP are working on developing an exchange.
The term “suspect product" means a product for which there is reason to believe that such product: (A) is potentially counterfeit, diverted, or stolen; (B) is potentially intentionally adulterated; (C) is potentially the subject of a fraudulent transaction; or (D) appears otherwise unfit for distribution.
The term “illegitimate product" means a product for which credible evidence shows that the product meets one or more of the above standards.
Examples of products that would be considered “suspect" and should be investigated include:
- Products that are abnormal in appearance. This may include smudged or misspelled labels, unusual coloration or shape of the package, missing security features, or dosage forms that are different in color, shape, or imprint from the normal product.
- Products that arrive with missing or incomplete information, such as incomplete shipping information or missing package inserts, lot numbers, expiration dates, or National Drug Codes.
FDA has issued guidance to help identify suspect product.
If
a pharmacy determines a product is suspect, they must quarantine and
investigate the suspect prescription drug to determine if the drugs are illegitimate. If the product
is discovered to be illegitimate after investigation,
the pharmacy must then report this to the wholesaler, manufacturer, and FDA.
Yes, the DSCSA allows a pharmacy to sell to another pharmacy, without being licensed as a wholesale distributor, to address a specific patient need. The seller does not have to supply transaction history, transaction information, and a transaction statement if the sale is fulfilling a specific patient need. Both pharmacies will still have to document the sale.
Specific patient need “refers to the transfer of a product from one pharmacy to another to fill a prescription for an identified patient. Such term does not include the transfer of a product from one pharmacy to another for the purpose of increasing or replenishing stock in anticipation of a potential need."
Yes, intracompany distribution of product and distribution among hospitals or other health care entities that are under common control are exempted from the definition of a transaction.
The transaction history, transaction information and a transaction statement are not required. The pharmacies will still have to document the transfer.
Yes, the DSCSA exempts distribution of minimal quantities of product from a pharmacy to a practitioner from the definition of transaction. Kentucky limits that distribution in a twelve (12) month period to less than five percent (5%) of the total number of units dispensed by the pharmacy during the immediate twelve (12) month period.
The pharmacy does not have to supply the practitioner with a transaction history, transaction information, and a transaction statement. The pharmacy will still have to document the sale.
The purchasing pharmacy must maintain
the transaction history,
transaction information and transaction statement for the products
acquired by the closing pharmacy.
FDA has a variety of resources including published guidance documents and frequently asked questions.
NABP also has a resource page on DSCSA specifically for dispensers.
On November 1, 2022, United States Pharmacopeia (USP) published revisions to their pharmaceutical compounding standards chapter 795 (nonsterile preparations) and 797 (sterile preparations) with an anticipated implementation date of November 1, 2023, for both.
The following presentation is a broad comparison of the major differences between the currently implemented guidelines and the 2022 revisions. The presentation is not meant to be a comprehensive guide for implementation for the revisions.
USP 797 and 795 presentation
The amendments to 201 KAR 2:076 became effective on October 25, 2023. The amendments reflect the adoption by the Board of the 2022 revisions for USP 797 and USP 795 standards and include USP 800 as it relates to compounding.
Highlights of the regulation include:
- The addition of the Designated Person (definition and responsibilities).
- Definitions for “essential copy of a commercially available drug product" and “hazardous drug" and rules regarding both terms.
- The addition of a flavoring will not be considered compounding if the additive is non-expired, inert, nonallergenic, produces no effect other than the instillation or modification of flavor and is not greater than five (5) percent of the drug product's total volume.
- The dispensing of compounded preparations for veterinary use shall follow the requirements of 201 KAR 2:311.
- Verification of a compounded preparation shall be completed by a pharmacist after the preparation of the compound and prior to dispensing to the patient.
- Enforcement Discretion: Effective January 1, 2026 the board shall enforce the 2022 revisions. Until January 1, 2026 the board shall enforce the 2014 revision of USP 795 and the 2008 revision of USP 797, and the board shall not enforce USP 800.
Until January 1, 2026 at the request of a permit holder the board may inspect pursuant to the 2022 revision standards.
Compounding a commercially available product is allowable only in certain narrow circumstances, as described in the 2025 Update.
The Board is charged with protecting the public. Therefore, compounding semaglutide or tirzepatide drug products in a way that fails to conform with governing law may lead to enforcement action by the Food and Drug Administration and the Kentucky Board of Pharmacy.
Pharmacies should also be aware that pharmaceutical manufacturers may initiate legal proceedings against prescribers and compounders to combat illegal semaglutide or tirzepatide drug product compounding.
201 KAR 2:076 governs the preparation of compounded drug products. Compounding is also governed by the federal Drug Quality and Security Act and by applicable United States Pharmacopeia chapter standards, which are incorporated as a matter of federal and state law.
201 KAR 2: 311
The FDA’s most current statement of regulatory policy governing veterinary compounding may be found here: FDA Regulation of Animal Drugs. Included in the resources at this link is FDA’s final Guidance for Industry #256, Compounding Animal Drugs from Bulk Drug Substances.