Kentucky Board of Pharmacy March 2014 Newsletter

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2013 Kentucky Pharmacy Law Review, Friday, April 19, 2013, Griffin Gate Marriott Resort & Spa, Lexington, KY

Overview

This one day event is geared at touching on the most current changes in the law and pharmacy practice effecting the pharmacy profession today. You will have a chance to hear firsthand what is coming out of the General Assembly, talk to the Board of Pharmacy, get information on the medication errors associated with HIT to raise awareness of these new types of errors and discuss strategies for prevention, update on pharmaceutical compounding, and  discuss the implications for pharmacists with regard to Naloxone rescue policy

More information provided here

Kentucky Board of Pharmacy Discusses Compounding During November Meeting

To view agenda click here

Kentucky: Pain Clinic Owners and Doctors Charged in Prescription Drug Conspiracies

August 17, 2012; U.S. Attorney; Eastern District of Kentucky

Local and Out of State Pain Clinic Owners and Doctors Charged in Prescription Drug Conspiracies 
PIKEVILLE-Between today and late Thursday afternoon, five indictments have been unsealed charging 22 defendants, including five pain clinic owners and six doctors, with offenses related to prescription drugs, money laundering, and health care fraud.

Kentucky Law Regarding Compounding for a Practitioner's Office or Institutional Administration

201 KAR 2:310. Compounding for a practitioner’s office or institutional administration.
RELATES TO KRS 315.191(1)(a).
STATUTORY AUTHORITY: KRS 315.191(1)(a)
NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1)(a) requires the board to
promulgate administrative regulations to regulate and control all matters relating to
pharmacists, pharmacist interns, pharmacy technicians, and pharmacies. This administrative
regulation addresses compounding for use by a practitioner’s office administration or
institutional administration.
Section 1. A pharmacist, pharmacist intern, or pharmacy technician may prepare a
compounded drug for a practitioner’s office administration or institutional administration.
Section 2. A compounded drug that contains a controlled substance shall not be
compounded for office or institutional administration.
Section 3. The pharmacist shall receive a written, verbal, facsimile, or electronic request for
a compounded drug from a practitioner, indicating the formulation, strength, and quantity
ordered.
Section 4. Label Requirements. A label shall be generated for the compounded drug and
shall include:
(1) The name of the practioner;
(2) The designated name and strength of the compounded drug;
(3) The quantity dispensed;
(4) A lot or batch number of the compounded drug;
(5) The beyond use date for the compounded drug;95
(6) The date the compounded is dispensed;
(7) The pharmacy's name, address, and telephone number;
(8) Any special storage requirements;
(9) A notation stating "For Office or Institutional Administration Only-Do Not
Dispense to Patient;
(10) Any auxiliary label required for the compounded drug.
Section 5. The compounded drug shall be administered in the practitioner’s office or
institution and shall not be dispensed to the patient.
Section 6. The prescription for the compounded drug shall be kept pursuant to 201 KAR
2:170.
(35 Ky.R. 1954; 2006; eff. 3-11-09.)

Found here.

Is Over-the-Counter Product Compounding Allowed in Kentucky?

The March 2012 Newsletter of the Kentucky Board of Pharmacy contains the following question and answer:

II. Over-the-counter product compounding: is it permissible?
The answer is found in the definition in Statute KRS 315.010:
(5) “Compound” or “compounding” means the preparation or labeling of a drug pursuant to or in anticipation of a valid prescription drug order including, but
not limited to, packaging, intravenous admixture or
manual combination of drug ingredients. “Compounding” as used in this chapter, shall not preclude simple reconstitution, mixing, or modification of drug products prior to administration by non-pharmacists.
The definition states pursuant to or in anticipation of a prescription for the preparation or labeling of a drug. Per KRS 315.010:
(9) “Drug” means any of the following:
(a) Articles recognized as drugs or drug products in any
official compendium or supplement thereto;
(b)Articles, other than food, intended to affect the
structure or function of the body of man or other
animals;
(c) Articles, including radioactive substances, intended for use in the diagnosis, cure, mitigation,
treatment or prevention of disease in man or other
animals; or
(d)Articles, intended for use as a component of any
articles specified in paragraphs (a) to (c) of this
subsection;
Based on the definition provided in the statute, compounded
legend and nonlegend drugs must be pursuant to a valid prescription in Kentucky.

The newsletter can be found here.

Another Example of a Federal Prosecution Involving Compounded Drugs

Former Vice-President Of Pharmacutical Company Pleads Guilty To FDA Violations And Health Care Fraud

– Company received more than $2 million in payments from Medicare for misbranded, adulterated and contaminated inhalation medications

February 7, 2012

LOUISVILLE, KY – The former vice-president of National Respiratory Services, LLC (NRS) has pled guilty in United States District Court before Chief Judge Joseph H. McKinley, Jr., to charges of misbranding and altering drugs and to committing health care fraud announced David J. Hale, United States Attorney for the Western District of Kentucky.
Johnny Perry, age 62, of Mt. Washington, Kentucky, was indicted by a federal grand jury in Louisville on August 3, 2011. The five count indictment alleged that between June of 2006 and June of 2008, Perry, as vice-president of NRS, provided compounded medications to patients, but led both Medicare and the patients’ doctors to believe that the pharmaceutical company was providing non-compounded medications (FDA approved-commercially manufactured). Compounded medications are not FDA approved, but FDA regulations permit pharmacists to make compounded drugs, including prescription drugs, in limited amounts and under narrow circumstances, for particular patients, and at the direction of a physician when other available drugs cannot be prescribed.
The defendant, through the NRS Corporation submitted false and fraudulent claims to Medicare for the cost of FDA-approved, commercially manufactured, prescription inhalation drugs, when they were not. As a result of this conduct, NRS received approximately $2,030,343 in payments from Medicare to which they were not legally entitled.

It is further alleged that Ms. Perry, aided and abetted by others, from November 2006 through June 2008, misbranded inhalation drugs in that they contained false and misleading labeling that misrepresented the strength and potency of their active ingredients or the type of drug actually provided. During the same period it is alleged that Perry, aided and abetted by others, adulterated inhalation drugs in that the strength differed from what it was purported or represented to possess and that the drugs were contaminated and non-sterile.
“This case should send a clear message that offenses endangering public health will be vigorously prosecuted,” stated U.S. Attorney David J. Hale. “Misrepresenting the strength and potency of a prescribed medication and delivering contaminated products to patients are unconscionable crimes.”
“The Office of Inspector General is committed to protecting the health of patients covered by Medicare and Medicaid,” said Derrick L. Jackson, Special Agent in Charge of the U.S. Department of Health and Human Services in Atlanta, Georgia, “This company billed for medications that never should have been dispensed in the first place which created serious quality of care concerns.”
The maximum potential penalties are 46 years in prison, a $770,000 fine, and supervised release for a period of 3 years.
The case is being prosecuted by Assistant United States Attorney Lettricea Jefferson-Webb and Assistant United States Attorney James Lesousky, and it was investigated by the Food and Drug Administration, Health and Human Services Office of Inspector General, United States Postal Inspection Service, and the Federal Bureau of Investigation.

Press Release Found here.