1. "Brand name" means the name that a manufacturer of a drug or pharmaceutical places on the container thereof at the time of packaging.
2. "Generic name" means the name that a manufacturer of a drug or pharmaceutical.
3. "Practitioner" means any person licensed under the professional laws of this state to prescribe
and administer medicine and drugs.
4. "Pharmacist" means any person licensed as such by the Kentucky Board of Pharmacy.
5. "Equivalent drug product" means a product with the same generic name, active ingredients,
strength, quantity and dosage form as the drug product identified in a prescription.
6. "Board" means the Kentucky Board of Pharmacy.
7. "Nonequivalent drug product formulary" means a formulary of drugs, drug products, and dosage
formulations for which there are no equivalent drugs, drug products, or dosage formulations and
which have been determined to be noninterchangeable or to have actual or potential bioequivalency
problems by the United States food and drug administration and are contained in a drug bioequiva-
lence problems list as published in the United States food and drug administration publication
entitled "Approved prescription drug products with thereapeutic equivalence evaluations" with sup-
plements.
8. "Dosage formulation" shall include, but not be limited to, those specific dosage forms which, by
the nature of their physical manufacture are deemed to be nonequivalent to other similar formula-
tions such as controlled release tablets, aerosol - nebulizer drug delivery systems and enteric
coated oral dosage forms. (Enact. Acts 1972, ch. 126, 1; 1982, ch. 399, 1, eff. 07/15/82.)
(2) The board shall provide for an annual distribution of copies of such formulary and revisions and additions thereto among pharmacies licensed within the Commonwealth and shall supply a copy to any person on request upon payment of the price established by the board. such formulary shall be revised and distributed as often as new and pertinent information on drugs, drug products, and dosage formulations becomes available from the United States food and drug administration. (Enact. Acts 1972, ch. 126, 6, eff. 07/15/82.)
(2) When an equivalent drug product is dispensed in lieu of a brand name drug prescribed, the price of the equivalent drug product dispensed shall be lower in price to the purchaser than the drug product prescribed.
(3) If, in the opinion of a practitioner, it is to the best interest of his patient that an equivalent drug should not be dispensed, he may indicate in the manner of his choice on the prescription "Do Not Substitute," except that the indication shall not be pre-printed on a prescription.
(4) The selection of any drug by a pharmacist under the provisions of this section shall not constitute the practice of medicine.
(5) A pharmacist who selects and equivalent drug product pursuant to KRS 217.815 to 217.826 assumes no greater liability for selecting the dispensed drug product than would be incurred in dispensing a prescription for a drug product prescribed by its generic name.
(6) When a pharmacist receives a generically written prescription for a multiple source drug product, he shall dispense an equivalent drug product in accordance with the provisions of KRS 217.815 to 217.826. (Enact. Acts 1972, ch. 126. 8; 1976, ch. 274, 2; 1982, ch. 399, 4, eff. 07/15/82.)
(2) Every pharmacy shall retain for a period of two (2) years from July 15, 1982 a pharmacy record of all prescribed drug products dispensed. The pharmacy record shall be retained for the purpose of providing valid date for bona fide research and reporting to the General Assembly as to the effectiveness of KRS 217.815 to 217.826. the pharmacy record shall include:
(a) The brand name of the drug, when applicable.(b) the name of the manufacturer or the supplier of the drug, if the drug has no brandname.
(c) The strength of the drug, when significant.
(d) The quantity dispensed, when applicable.
(e) The serial number of the prescription.
(f) The date the prescription was originally dispensed and refilled.
(g) The name of prescribing physician.
(h) The name of patient for whom the drug was prescribed.
(i) The price for which the drug was sold to the purchaser.
(j) A notation if the practitioner indicated "Do not Substitute" or the purchaser refused the product selected. (Enact. Acts 1982, ch. 399, 5, eff. 07/15/82.)
(2) Distributor means any person, corporation, or other entity which distributes for resale a legend drug under its own label even though it is not the actual manufacturer of the legend drug.
(3) Solid dosage form means capsules, tablets, or similar legend drug products intended for oral administration.
(4) Board means the Kentucky Board of Pharmacy. (Enact. Acts 1982, ch. 5, 1, eff. 07/15/82.)
(2) Every person engaged in sales of hypodermic syringes or needles at retail shall maintain a bound record in which shall be kept
(a) The name of the purchaser; and(3) Said record shall be maintained for a period of two (2) years from the date of the sale and shall be available for inspection during business hours by any law enforcement officer, agent or employee of the Cabinet for Human Resources or Board of Pharmacy engaged in the enforcement of KRS Chapter 218A.(b) The address of the purchaser; and
(c) The quantity of syringes or needles purchased; and
(d) The date of the sale; and
(e) Planned use of such syringes or needles.
(4) No person shall present false identification or give a false or fictitious name or address in obtaining or attempting to obtain any hypodermic syringe or needle.
(5) No person engaged in the retail sale of hypodermic syringes or needles shall:
(a) Fail to keep the records required by this section; or(6) Any physician, other licensed medical person, hospital, or clinic disposing of hypodermic syringes or needles shall crush the barrel of same or otherwise render the instrument incapable of further use.(b) Fraudulently alter any record required to be kept by this section; or
(c) Destroy, before the time period required by this section has elapsed, any record required to be kept by this section; or
(d) Sell, or otherwise dispose of, any hypodermic syringe to any person who does not present the identification required by this section; or
(e) Disclose the names in said book except to those required by this section.
(Enact. Acts 1974, ch 404, 1)
(2) "Sexually transmitted disease" means syphilis, gonorrhea, chancroid, granuloma inguinale, genital herpes, non-gonococcal urethritis, mucopurulent cervicitis, acquired immune deficiency syndrome (AIDS),chlamydia trachomatis infections and any other sexually transmitted disease designated by the cabinet under the provisions of KRS Chapter 13A
(2) All information, records and reports concerning persons infected with or suspected of being infected with or tested for or identified in an epidemiologic investigation for sexually transmitted disease are hereby declared to be strictly confidential and only personnel of local health departments and the cabinet for human resources who are assigned to sexually transmitted disease control activities shall have access to such information, records and reports.
(3) No court, board, agency or other judicial or quasi-judicial body shall issue any subpoena or subpoena duces tecum or other order to any local health department or cabinet for human resources personnel to disclose any information, records or reports concerning persons infected with or suspected of being infected with or tested for or identified in an epidemiologic investigation for sexually transmitted disease. The intent of this section is to strictly protect and preserve the principle of confidentiality of such individuals.
(4) Nothing in this section shall be construed as preventing:
(a) The release of medical information to the physician retained by the person infected with or suspected of being infected with a sexually transmitted disease;(b) The release of medical or epidemiological dab or information for statistical purposes in a manner 80 that no individual person can be identified;
(c) The release of medical information with the written consent of all persons identified in the information to be released;
(d) The release of medical or epidemiological information necessary to enforce the provision of the rules and regulations of the cabinet for human resources, issued pursuant to KRS Chapter 13A, relating to the control and treatment of sexually transmitted disease; and
(e) The release of medical information made to medical personnel in a medical emergency to the extent necessary to protect the health or life of the named party.
(2) Any owner or person having charge of any public or private conveyance, including watercraft, who refuses to obey the rules and regulations made by the cabinet for human resources under KRS 214.020 shall, for each offense, be fined not less than fifty dollars ($50) nor more than five hundred dollars ($500) or imprisoned in the county jail for not less than ten (10) nor more than sixty (60) days, or both.
(2) "Outpatient drug program" means the program of drug services provided directly by pharmacists to Medicaid recipients, including both the drug product and dispensing of the drug.
(1) Coverage for outpatient drugs shall be limited to drugs for which thedrug manufacturer has entered into and complies with a rebate agreement under 42 USC 1396s(a) which are prescribed or a medically accepted indication, and those drugs with a preauthorized exemption from the rebate agreement granted by the Health Care Financing Administration.
(2) Drugs included on the Kentucky Medical Assistance Program Outpatient Drug List (as published by the Cabinet for Human Resources) may be provided without preauthorization. Preauthorization shall be required for all other drugs.
(3) The drugs or classes of drugs listed in 42 USC 1927s(d)(2) shall be excluded from coverage unless specifically (individually by drug within the class) placed on the outpatient drug list or preauthorized using the usual preauthorization criteria of the department for Medicaid services.
(4) Prescribing quantities may be limited by the program.
(5) Patients placed in "lock-in" status due to overutilization shall receive services only from their lock-in provider except in the case of emergency or referral.
(6) Practitioner authorization, i.e., actual signature of the prescriber, shall be required on all prescriptions not phoned in, on all Schedule ll controlled substances prescriptions and when the physician override (certification of brand name necessity) procedure is being used. For telephone prescriptions (but not including the preceding) the pharmacist shall enter on the prescription form the name of the prescriber and the initials of the pharmacist.
(7) No prescription shall be refilled more than five (5) times, or more than, six (6) months after the original prescription is written
(8) Drugs, provided to recipients in institutions in which drugs are considered a part of the reasonable allowable costs under the Kentucky Medical Assistance Program, shall not be billed as an outpatient pharmacy benefit.
(9) Drugs provided to recipients in nursing facilities (except for patients in head injury units and units providing care for ventilator dependent patients) shall be billed as an outpatient pharmacy benefit
(10) Legend drugs, of a type not included on the Kentucky Medical Assistance Program Outpatient Drug List, and which will prevent hospitalization or a higher level of care of the patient, shall be considered covered for individual recipients when preauthorized by qualified medical professionals within the Department for Medicaid Services.
(11) Drugs of a type not on the KMAP outpatient drug list may be placed on a preauthorization list and authorized as a group for recipients in personal care homes and for those recipients in nursing facilities who meet patient status criteria for the facility.
(12) Drugs for which the Food and Drug Administration has issued a "less than effective (LTE)" rating and drugs which are determined to be "identical, related, or similar to LTC drugs" shall not be covered.
(a) An appropriate rebate agreement must have been signed by the manufacturer or labeler or the drug must be provided based on a preauthorized exemption from the rebate requirement.(2) Reimbursement to hospitals for drugs provided to eligible recipients shall be on the basis of reasonable cost pursuant to 907 KAR 1:013. While reimbursement for drugs provided to patients in brain injury units in nursing facilities and units providing ventilator dependent care in nursing facilities is within the all inclusive rate for the brain injury unit or ventilator care unit, the upper limits in this regulation shall be applicable with regard to payments for drugs provided in those settings.(b) Drug costs shall be determined in the pharmacy program using a computerized price listing service with pricing based on the actual package size utilized.
(c) If an average wholesale price is listed, reimbursement for the, drug cost shall be the lesser of the federal maximum allowable cost (FMAC) or average wholesale price (AWP) minus ten (10) percent plus a dispensing fee (and unit dose add-on, as appropriate) or the usual and customary billed charge unless the physician has written "do not substitute" or "brand necessary" on the prescription.
(d) If an AWP is not listed, reimbursement shall be the lesser of the FMAC or direct price plus a dispensing fee (and unit dose add-on as appropriate), or the usual and customary billed charge unless the physician has written "do not substitute" or "brand necessary" on the prescription.
e) If the physician has written "do not substitute" or "brand necessary" on the prescription, reimbursement shall be based on the lower of the pharmacy's usual and customary charge or the estimated acquisition cost (EAC) (AWP minus ten ( 10) percent or direct price as appropriate) for the respective drug plus a dispensing fee (and unit dose add-on, as appropriate).
(f) For nursing facility residents meeting Medicaid patient status criteria, there shall be no more than one (1) dispensing fee allowed per drug within a calendar month for maintenance drugs (as determined by the Medicaid agency), and no more than two (2) dispensing fees allowed per drug within a calendar month for other drugs, except for Schedules II, III, and IV controlled substances and for non-solid dosage forms, including topical medication preparations, for which no more than four (4) dispensing fees per drug shall be allowed within a calendar month. For nursing facility residents not meeting Medicaid patient status criteria and nonresidents of nursing facilities, there shall be no more than one(1) dispensing fee allowed per drug per calendar month for drugs classified by the Medicaid Program as maintenance drugs and no more than four (4) dispensing fees shall be allowed per drug within a calendar month for legend intravenous drugs. Though dispensing fees are limited, this shall not be construed as placing a limit on the quantity of reimbursable drugs for which the program will pay for any patient, since the reasonable cost of the drug (as defined herein) is reimbursable as a covered service in whatever quantity is considered medically necessary for the patient. Nonsolid dosage forms include all covered drug items other than oral tablets or capsule forms.
(g) Whenever possible, unused drugs paid for by the cabinet shall be returned to the pharmacy with the credit for the cost of the drug and the unit dose packaging cost (if applicable) accruing to the cabinet.
(2) For eligible recipients in nursing facilities meeting the appropriate patient status criteria requirements, the dispensing fee shall be five (5) dollars and seventy-five (75) cents per prescription for drugs reimbursed through the outpatient drug program for these recipients, a unit dose addition to the usual dispensing fee shall be made for drugs dispensed through the pharmacy outpatient drug program in the amount of two (2) cents per unit dose for unit dose drugs packaged in unit dose form by the manufacturer and four (4) cents per unit dose for unit dose drugs packaged in unit dose form by the pharmacist; the unit dose dispensing fee amount shall be paid, as appropriate, even though the usual dispensing fee of five (5) dollars and seventy-five (75) cents is not paid due to monthly limits on dispensing fees.
(1)Artificial devices prescribed by a licensed physician, or designed, constructed or altered for the use of a particular crippled person.(2) Artificial limbs, artificial eyes, hearing aids prescribed by a licensed physician.
(3) Crutches wheelchairs, walkers, hospital beds, and wheelchair lifting devices for the use of invalids and crippled persons;
(4) Insulin, and diabetic supplies, such as hypodermic syringes and needles, and sugar (urine and blood) testing materials purchased for use by diabetics; and
(5) Colostomy supplies
Corrective eyeglasses are subject to tax.
a. Reasons given are foreign counterfeits and proper storage requirements.b. The drugs may be reimported by the original manufacturer.
c. The Secretary may authorize reimportations if needed for emergencies.
2. Prohibits the sale, purchase or trade of any drug which:
a. Was purchased by a public or private hospital or other health care entity.3. Does not prohibit the sale or exchange of drugs purchased by hospitals involved in a group purchasing organization.b. Was donated or supplied at a reduced price to a "charitable organization" as designated by the IRS.
4. Violation of Section 4 provisions is made a felony punishable by up to 10 years in prison and/or a fine of up to $250,000.
5. Coupons were included in this section to deter counterfeit coupons.
a. practitioners licensed in the State to prescribe2. Manufacturers must store drug samples under conditions that will maintain their stability, integrity and effectiveness. Theoretically manufacturers would have to store their samples in a like manner.b. in response to a written request on a form that contains:
1. name, address, Prof. designation signature of prescriberc. providing that once the samples are received a receipt is signed by the prescriber and returned to the manufacturer2. identity of drug and quantity requested
3. name of manufacturer of drug sample requested
4. date of the request
d. samples may be delivered to a pharmacy of hospitals or other health care entities at the request of the prescriber.
e. samples may be delivered by common carrier, mail or by the manufacturers representative, providing the above requirements are met
f. manufacturers must maintain copies of all requests and receipts for a period of 3 years & a record of drugs distributed as well as the recipients.
g. all information pertaining to the records kept shall be made available to Federal State officials engaged in drug enforcement
3 . A manufacturer must:
a. conduct an annual inventory of all samples in the possession of representatives and they must maintain a list of the names and addresses of representatives who distribute drug samples.4. "Samples" do not include recalled drugs, exchanges of outdated products, or investigational new drugs(IND's)b. maintain records of drug samples distributed, destroyed, returned to the manufacturer, and losses due to theft or other significant shrinkage.
c . make the above records available to the Secretary upon request.
d. notify the Secretary of any significant loss or theft of samples e. notify the Secretary of any conviction of their representatives for violations of this law or any other State law where samples were involved f. provide the Secretary the name and telephone no. of the individual responsible for samples for the company.
5. "coupons", which are not samples, are an alternative means of providing samples and are not subject to these restrictions.
6. A request for samples must be made each time a prescriber wants samples. standing written request for samples by a prescriber is prohibited.
2. The section divides distributors into 2 categories:
a. authorized distributors---distributors who have an ongoing relationship with a particular drug manufacturer3. Unauthorized distributors will be required to certify in writing to drug wholesalers the source and place from which they obtained their drugs.b. unauthorized distributors-Q-distributors who do not have an ongoing business relationship with a manufacturer to provide wholesale distribution of that manufacturer's product.
4. Manufacturers will required to maintain, for public review, a current list of all authorized distributors of record.
5. Any firm engaging in the wholesale distribution of pharmaceuticals shall be 1 licensed in the state in which it does business (where its distribution facility is located ) . for wholesalers regarding the handling and storage of pharmaceuticals.
a. illegal importation of prescription drugs2. Manufacturers are subject to the following penalties if the representative is convicted of illegally selling or trading drug samples:b. sale, purchase or trade of a drug sample
c. sale, purchase or trade of a coupon or counterfeit coupon
d. counterfeiting of a coupon
e. distribution of drugs by licensed wholesalers
a. fine of not more than 50,000 for each of the first two such convictions within a 10 year periodb. fine of not more than $l ,000,000 for each conviction after the first two in any 10 year period.
c. If more than one representative is involved or the representative is convicted on more than one count, the incident only counts as one violation toward the manufacturer.
d . Failure to make necessary reports leads to not more than a i100.000 fine
e. If a manufacturer provides information that leads to the arrest and conviction of a representative involving samples, the conviction shall not be considered a violation for the company.
f. If a manufacturer investigates illegal sample activities and is unable to prove the allegations and subsequently the representative is prosecuted, the manufacturer will not be found in violation.
g. If a person provides information leading to the arrest and conviction of a person for violating the provisions of the "Prescription Drug Marketing Act", the person may be entitled to one-half of the criminal fine imposed and collected for such violation but not to exceed $125,000.
(14) The board may authorize only those persons who have qualified for use of diagnostic pharmaceutical agents as set out in subsection (13) of this section to utilize and prescribe topical therapeutic pharmaceutical agents in the examination or treatment of nay condition of the eye or itsappendages. The utilization or prescribing of topical therapeutic pharmaceutical agents shall be limited to those persons who have sufficient education and professional competence as determined by the board and who have earned transcript credits of at least six (6) semester hours in a course or courses in general and ocular pathology and therapy, with particular emphasis on utilization of therapeutic pharmaceutical agents from a college of university accredited by a regional or professional accreditation organization which is recognized or approved by the council on post-secondary accreditation or by the United States Department of Education. These six (6) semester hours are in addition to the six (6) semester hours required by the subsection (13) of this section, making a total of twelve (12) semester hours.
(15) Any optometrist authorized by the board to utilize diagnostic pharmaceutical agents shall be permitted to purchase for use in the practice of optometry diagnostic pharmaceutical agents limited to miotics for emergency use only, mydriatics, cycloplegics, and anesthetics to be applied topically only. Any optometrist authorized by the board to utilize topical therapeutic pharmaceutical agents shall be permitted to prescribe in the practice of optometry topical therapeutic pharmaceutical agents. Optometrists so authorized by the board to purchase pharmaceutical agents shall obtain them from licensed drug suppliers or pharmacists on written orders placed in the same or similar manner as any physician or other practitioner authorized by KRS Chapter 217. Purchases shall be limited to those pharmaceutical agents specified in this subsection and in subsection (13) of this section, based upon the authority conferred upon the optometrist by the board consistent with the educational qualifications of the optometrist as set out herein. All purchases of pharmaceutical drugs by optometrists shall be upon purchase order forms approved by the board. (Enact. Acts 1954, ch. 183, 5; 1978, ch 179, 2, effective June 17, 1978; 1986, ch. 12, 2, effective July 15, 1986; 1990, ch. 256, 8, effective July 13, 1990).
Should you have questions regarding this Bill, please call the Board of Nursing at 502-329-7000.
Drug products that FDA considers to be therapeutically equivalent to other therapeutically equivalent products. There are no known or suspected bioequivalence problems. These products are designated as AA, AN, AO, AP or AT depending on dosage form.
AA = products not presenting bioequivalence problems in conventional dosage forms.
AB = products with actual or potential bioequivalence problems which have been resolved with adequate in vivo and/or in vitro evidence supporting bioequivalence.
AN = solutions and powders for aerosolization
AO = injectable oil solutions
AP = injectable aqueous solutions
AT = topical products
Code = "B"
Drug products that FDA does NOT at this time consider to be therapeutically equivalent to other pharmaceutically equivalent products or, bioequivalence problems have not been resolved. These products are designated BC, BD, BE, BN, BP, BR, BS, BT, or BX depending on dosage form.
BC = controlled release tablets, capsules & injectables
BD = active ingredients and/or dosage form have documented bioequivalence problems.
BE = enteric coated oral dosage forms
BN = products in aerosol-nebulizer drug delivery systems
BP = active ingredients & dosage forms with potential bioequivalence problems
BR = suppositories or enemas for systemic use
BS = products have standard deficiencies
BT = topical products with bioequivalence problems
BX = insufficient data
Note: The FDA Orange Book does NOT list all drug products on the market. Some have not been evaluated yet and most of the drugs still being prescribed that were approved before 1962 have not and will not be evaluated by FDA.(DESI Drugs)
1. Methyldopa "generic substitution made for" AldometThe label must refrain from wording such as "same as" or any inference that the substitution is the same as the trade name drug. Using only the trade name and the generic name on the label is not acceptable when denoting drug product selection. These alternatives were adopted y the Board to meet the requirement when the physician requests that both names appear on the label. This also should help those pharmacists supplying nursing homes and are required to have the name of the medication as it appears on the physician's order in the chart.2. Methyldopa "dispensed in place of" Aldomet
3. Methyldopa "substituted for" Aldomet
4. Methyldopa "generic for" Aldomet
5. Methyldopa "dispensed for" Aldomet
6. Methyldopa "generic as" Aldomet
The minimum internship required as a prerequisite for licensure examination shall be fifteen hundred (1500) hours; not more than forty-eighty (48) hours of internship may be allowed for credit in any one calendar week.
Any person who has successfully completed the second academic year in an accredited college may apply for registration as a pharmacy intern with the board. A maximum of 500 hours of internship may be obtained prior to actual participation in classes in an accredited college/school of pharmacy.
The board shall furnish application blanks and issue a registration identification card to each applicant who meets the requirements for registration as a pharmacy intern upon receipt of a completed application and the twenty-five dollars ($25.00) fee. The registration identification card shall be valid for four (4) years from date of issue. The pharmacy intern shall have his registration identification card in his possession at all times when on duty, and it shall be exhibited by the holder upon request of any member of the board or its authorized inspectors.
Form I must be submitted only once, requesting registration as a pharmacy intern, and accompanied by the fee.
Internship registration shall be limited to those persons who are actively engaged in meeting the academic or practical experience requirement for licensure examination. No person who terminates the educational requisites is entitled to the privileges of internship registration, with the exception of any hardship case given written approval by the board.
No person not registered with the board as a pharmacy intern shall take, use, or exhibit the title pharmacy intern, pharmacy apprentice, pharmacy extern, or any term of similar or like import.
Internship may be acquired only under the supervision of a preceptor certified by the Kentucky Board of Pharmacy. The preceptor must have been licensed by the board for at least one year and be actively engaged in the practice of pharmacy full-time in the pharmacy where the pharmacy intern is to obtain his internship. a preceptor may supervise and be responsible for only one pharmacy intern at a time.
The term, "Supervision," shall mean that in the pharmacy where internship is being obtained, the preceptor shall be in personal contact with and actually giving professional instructions to the pharmacy intern during the entire period of such internship. Internship shall be credited only when it has been obtained in a pharmacy acceptable to the board for such purpose, except:
(1) Up to four hundred (400) hours may be obtained in areas other thantraditional community or institutional pharmacy practice settings (e.g., research, manfacturing). To receive credit for such experience, a written request must be submitted to the board for approval prior to beginning the experience. The request shall include a description of the place, duties, dates, and professional supervision of the contemplated internship. Upon completion of the experience and before approval for credit by the board, the pharmacy intern must submit a descriptive essay of the experience obtained.
An appropriate internship manual shall be utilized by a preceptor in teaching and evaluating a pharmacy intern.
Two-thirds of the intern's time is required in processing of prescriptions and counseling patients.
Form II must be submitted in duplicate within ten (10) days from the beginning of internship. Form II must be resubmitted in duplicate within ten (10) days if change in preceptor.
A separate Form III for each preceptor ust be submitted in duplicate by October 1 of each year for all internship experience obtained the preceding twelve months. The duplicate copies will be acknowledged and returned to the pharmacy intern after October 1 to be made a part of his records for future use. For out of state internship credit Form III must also be signed by an official of the board of pharmacy of the state where internship was obtained.
A maximum of 500 hour internship credit may be obtained concurrent with enrollment in an approved college of pharmacy in didactic courses. Such concurrent time is limited to a maximum of twenty (20) hours per week. Concurrent time will apply when any student with the status of full-time established by the university, college, or school is enrolled in and is attending classes in a college or school of pharmacy with the exception of experiential courses examples of which are externship or clerkship courses offered by the college or school of pharmacy. Students enrolled in experiential courses may not gain additional internship hours during rotation, but may begin gaining hours upon completion. such time shall not be considered concurrent. students with the status of part-tim established by the university, college, or school may gain internship hours, none of which shall be considered concurrent. Part-time status must be documented in writing to the Kentucky Board of Pharmacy by the dean of the school/college of pharmacy.
Up to seven hundred and ten (710) hours internship credit (960 for Pharm.D.) may be obtained for the successful completion of structured board approved colleg of pharmacy experience programs/courses for which academic credit is awarded. As an example, the time allowed for externship, clerkship, elective and Pharm.d. programs at the University of Kentucky College of Pharmacy is as follows:
TRADITIONAL B.S.
PHR 881/828 -8 weeks x 40 hours/week = 320 hours
PHR 885 - 6 weeks x 40 hours/week = 240 hours
PHR 870 - 15 weeks/2 hours/5 days = 150 hours
Maximum B.S. Total = 710 hours
PHARM. D. PROGRAM
PHR 882/883/884 4 rotations of 8 weeks =640 hours
(20 hours/week)
PHR 881 8 weeks x 40 hours/week =320 hours
Maximum Pharm.D. Total =960 hours
The college advisor or instructor must sign the internship report Form IV provided by the board. Form IV must be submitted in duplicate upon completion of course/program. Out of state course/program credit for internship will be accepted in accordance to the above maximums.
It is the pharmacy intern's responsibility to see that all reports are filed with the board within the prescribed time limit and on the proper forms available from the board.
The board shall not allow credit for claims of internship required unless such claims can be corroborated by records on file in the board office.
A pharmacy intern having served part or all of his time in a pharmacy outside the state shall be given credit for the same, when affidavits of said employment are made by the preceptor showing exact times and dates served, and when preceptor and pharmacy are verified by the board of pharmacy in that state, in such cases, internship must be comparable and acceptable to the Kentucky Board of Pharmacy.
a. The drug is in a sealed container by which it can be readily determined by a pharmacist employed by the dispensing pharmacy or by the dispensing practitioner that entry or attempted entry by any means has not been made;
b. The drug container meets the standards of the United States Pharmacopoeia for storage conditions including temperature, light sensitivity, moisture, chemical and physical stability;
c. The drug labeling and packaging has not been altered or defaced and the identity of the drug, its potency, lot number, and expiration date are legible;
d. The drug does not require refrigeration; and
e. The drug is returned to a pharmacist employed by the dispensing pharmacy or to the dispensing practitioner within 14 days.
f. Subsections (d) and (e) shall be waived if all over conditions are met and if:
1. The drug was dispensed for a patient in a health care facility licensed by the Cabinet for Human Resources;
2. The drug has not come into the physical possession of the person for whom it was prescribed;
3. The drug has been under the continuous control of personnel in the health care facility who are trained and knowledgeable in the storage and administration of drugs;
4. The drug has been properly stored in an area which is regularly inspected by a Pharmacist; and
5. The drug is not expired.
G. Drugs distributed within an acute care facility shall be exempt from the provisions of subsections (a), (d) and (e) of this regulation.
2.Nothing in this regulation shall be construed to require any pharmacist
or practitioner to accept the return of any prescription drug.