General Questions

Q. How long do prescription records need to be kept?

A. 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 2:170

Q. How long do controlled substance inventory records need to be kept?

A. Controlled substance inventory records including invoices must be kept for five years. KRS 218A.200

Q. May records be stored off-site?

A. Permission to store records off-site must be requested and approved by the Board; requests should describe detailed storage conditions and security.  If offsite record storage is approved, 2 years of all records must still be kept on site.

Q. How does a pharmacy invoice prescribers for medications for office use?

A. 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

Q. The pharmacy was robbed/broken into; what do we do?

A. 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

Q. What immunizations may a pharmacist provide?

A. Pursuant to prescriber approved protocols a pharmacist may administer:
  • Adult immunizations
  • Immunizations to individuals nine (9) to seventeen (17) years old with the consent of a parent or guardian

Q. May a pharmacist administer a medication, such as a B12 injection?

A. 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

Q. What acts may an intern perform?

A. 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 B.S. or 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

Q. Who should be registered as a technician?

A. 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

Q. What medications are considered hazardous drugs?

A. The National Institute for Occupational Safety and Health (NIOSH) publishes a List of Antioneoplastic and Other Hazardous Drugs in Healthcare Settings.

Q. What is Kentucky law on generic substitution of a drug? 

A. 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

Q: Is an Authorized Generic Drug the same as a generic drug?

A: Per the FDA website, “No. The term ‘authorized generic’ drug is most commonly used to describe an approved brand name drug that is marketed without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product. An authorized generic may be marketed by the brand name drug company, or another company with the brand company’s permission. In some cases, even though it is the same as the brand name product, a company may choose to sell the authorized generic at a lower cost than the brand name drug.”  An example is Ventolin HFA and its authorized generic albuterol sulfate inhalation.  The FDA List of Authorized Generics is updated quarterly.
 
An authorized generic drug is not going to be AB rated to the brand name drug because the FDA will not rate a drug to itself.  The pharmacist may substitute an authorized generic drug for the brand name drug without contacting the prescriber. 

Q: What is Kentucky law on substitution of biologic products?

A: In order for the pharmacist to substitute a biosimilar or biologic product, Kentucky requires the biosimilar or biologic product to be interchangeable per the FDA Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.  Please refer to KRS 217.822 (10) to review the requirements for dispensing a biologic or biosimilar product.  KRS 217.822