File No. 16

Senate, March 8, 2007

The Committee on General Law reported through SEN. COLAPIETRO of the 31st Dist., Chairperson of the Committee on the part of the Senate, that the bill ought to pass.

AN ACT CONCERNING THE PRACTICE OF PHARMACY.

Be it enacted by the Senate and House of Representatives in General Assembly convened:

Section 1. Section 20-578 of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2007):

(a) Information received by the department, the commission or the Department of Public Health, through filed reports or inspection or as otherwise authorized under chapters 418 and 420b and sections 20-570 to 20-630, inclusive, shall not be disclosed publicly in such a manner as to identify individuals or institutions, except in a proceeding involving the question of licensure or the right to practice. Nothing in this section shall be construed to prohibit the commissioner from disclosing information gained through the inspection of pharmacies and outlets holding permits for the sale of nonlegend drugs if the commissioner considers such disclosure to be in the interest of public health.

(b) Notwithstanding the provisions of subsection (a) of this section, section 21a-265 and chapter 55, the Commissioners of Consumer Protection and Public Health and the authorized agents of said commissioners, in carrying out their duties under subsection (a) of this section, may: (1) Exchange information relating to a license or registration issued by their respective agencies, or (2) exchange investigative information relating to violations of this chapter with each other, with the Chief State's Attorney and with agencies charged with the enforcement of pharmacy or drug laws of the United States, this state and all other jurisdictions.

Sec. 2. Section 20-609 of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2007):

(a) A pharmacy license shall be conspicuously posted within the pharmacy.

(b) Any person owning, managing or conducting any store, shop or place of business not being a pharmacy who exhibits within or upon the outside of such store, shop or place of business, or includes in any advertisement the words "drug store", "pharmacy", "apothecary", "drug", "drugs", "medicine shop", or any combination of such terms or any other words, displays or symbols indicating that such store, shop or place of business is a pharmacy shall be fined not more than two hundred dollars or imprisoned not more than thirty days or both. The provisions of this subsection shall not apply to any person who provides pharmacy related services directly to pharmacies or practitioners and does not offer such services and drugs or medical services directly to the public.

Sec. 3. Section 21a-322 of the general statutes is repealed and the following is substituted in lieu thereof (Effective October 1, 2007):

The commissioner may suspend, revoke or refuse to renew a registration, place a registration on probation, place conditions on a registration and assess a civil penalty of not more than one thousand dollars per violation of this chapter, for sufficient cause. Any of the following shall be sufficient cause for [suspension, revocation or refusal to renew] such action by the commissioner: (1) The furnishing of false or fraudulent information in any application filed under this chapter; (2) conviction of a [felony] crime under any state or federal law relating to [any] the registrant's profession, controlled [substance] substances or drugs or fraudulent practices, including, but not limited to, fraudulent billing practices; (3) failure to maintain effective controls against diversion of controlled substances into other than duly authorized legitimate medical, scientific, or commercial channels; (4) the suspension, revocation, expiration or surrender of the practitioner's federal controlled substance registration; (5) prescribing, distributing, administering or dispensing a controlled substance in schedules other than those specified in the practitioner's state or federal registration or in violation of any condition placed on the practitioner's registration; (6) the restriction, suspension, revocation or limitation of a professional license or certificate as a result of a proceeding pursuant to the general statutes; (7) abuse or excessive use of drugs; (8) possession, use, prescription for use or distribution of controlled substances or legend drugs, except for therapeutic or other proper medical or scientific purpose; [and] (9) a practitioner's failure to account for disposition of controlled substances as determined by an audit of the receipt and disposition records of said practitioner; and (10) failure to keep records of medical evaluations of patients and all controlled substances dispensed, administered or prescribed to patients by a practitioner.

The following fiscal impact statement and bill analysis are prepared for the benefit of members of the General Assembly, solely for the purpose of information, summarization, and explanation, and do not represent the intent of the General Assembly or either chamber thereof for any purpose:

OFA Fiscal Note

State Impact:

Note: GF=General Fund

Municipal Impact: None

Explanation

This bill gives the Commissioner of Consumer Protection authority to discipline controlled substance registrants, by assessing a civil penalty up to $1,000 for certain violations. It also allows the Commissioner to place a registration on probation or place conditions on a registration. To the extent that civil penalties may be assessed for violations of certain registration conditions, a minimal revenue gain to DCP's Enforcement Fund may be realized. In FY 06, $358,497 was deposited into this fund, for all types of civil penalties.

The Out Years

The annualized ongoing fiscal impact identified above would continue into the future, as described above.



OLR Bill Analysis

SB 1088

AN ACT CONCERNING THE PRACTICE OF PHARMACY.

SUMMARY:

This bill (1) allows the commissioners of consumer protection and public health to exchange certain information with each other and law enforcement agencies, (2) increases the consumer protection commissioner's power to discipline controlled substance registrants, and (3) allows certain businesses that are not licensed pharmacies to use “pharmacy,” “drug,” and similar words in signs and advertisements.

EFFECTIVE DATE: October 1, 2007

INFORMATION EXCHANGE

This bill allows the commissioners of consumer protection and public health to exchange (1) information relating to a license or registration issued by their departments with each other and (2) investigative information relating to violations of the Pharmacy Practice Act with each other, the chief state's attorney, and agencies that enforce federal pharmacy or drug laws or those of other states and jurisdictions.

They may do so notwithstanding the laws prohibiting (1) both the departments and the Pharmacy Commission from disclosing information obtained through inspections, filed reports, or other authorized means if disclosure would identify individuals or institution unless doing so would benefit public health and (2) federal, state, county, and municipal law enforcement officers and third party payers who know prescriptions, orders, and records required by the law on dependency-producing drugs from divulging their knowledge except in connection with a civil suit or criminal prosecution in court or before a licensing or registration board or officer. Further, they may exchange information without complying with state law on personal data. The pertinent part of this law requires most state and municipal agencies that maintain a personal data system to keep a complete record concerning each person, of every individual, agency or organization that has obtained access to, or to whom disclosure has been made, of personal data and the reason for each disclosure or access. These records must be made available to a person on request. For this purpose, “personal data” is information about a person's education, finances, medical or emotional condition or history, employment or business history, family or personal relationships, and reputation that can be readily associated with a particular person (CGS § 4-190).

CONTROLLED SUBSTANCE REGISTRANTS

The bill increases the consumer protection commissioner's powers to discipline medical practitioners who have controlled substance registrations and expands the grounds on which the penalties may be imposed. For this purpose, the law defines a “practitioner” as (1) a physician, dentist, veterinarian, podiatrist, optometrist, licensed physician assistant, advanced practice registered nurse, nurse-midwife, scientific investigator, or another person licensed, registered, or otherwise permitted to distribute, dispense, conduct research with or administer a controlled substance or (2) a hospital or other institution permitted to distribute, dispense, conduct research with or administer a controlled substance. Practitioners must register with the Department of Consumer Protection (DCP) (CGS § 21a-316).

The bill authorizes the DCP commissioner to place a registrant on probation, place conditions on the registration, and impose a civil penalty of up to $1,000 per violation. The law already allows the commissioner to suspend, revoke, or refuse to renew a controlled substance registration.

The bill allows the DCP commissioner to take disciplinary action for (1) conviction of any crime related to drugs of the registrant's profession and fraudulent practices, including fraudulent billing practices, not just conviction of a felony related to controlled substances; (2) violation of a condition placed on a practitioner's registration concerning the prescription, distribution, administration, or dispensing of a controlled substance; and (3) failure to keep records of medical evaluations and all controlled substances dispensed, administered, or prescribed to patients.

USE OF “PHARMACY” IN SIGNS OR ADVERTISING

Current law prohibits stores that are not licensed pharmacies from using the words “drug store,” “pharmacy,” “apothecary,” “drug,” “drugs,” “medicine shop,” or other words or symbols that indicate that the store is a licensed pharmacy. The bill creates an exception for businesses that provide pharmacy-related services to pharmacies or medical practitioners and that do not provide services, drugs, or medical services to the public.

BACKGROUND

Grounds for Disciplining Controlled Substances Registrants

Under current law, the commissioner may discipline a registrant for (1) providing false or fraudulent information in a registration application; (2) conviction of a felony relating to a controlled substance; (3) failure to maintain effective controls against diversion of controlled substances; (4) suspension, revocation, expiration, or surrender of the practitioner's federal controlled substance registration; (5) prescribing, distributing, administering, or dispensing a controlled substance in schedules other than those specified in the practitioner's state or federal registration; (6) the restriction, suspension, revocation, or limitation of a professional license or certificate; (7) abuse or excessive use of drugs; (8) possession, use, prescription for use, or distribution of controlled substance or legend drugs, except for therapeutic or other proper medical or scientific purpose; and (9) failure to account for the disposition of controlled substances as determined by an audit of the practitioner's records.

Controlled Substances

Controlled substances are grouped in Schedules I through V, according to their decreasing tendency to promote abuse or dependency. Schedule I substances are the most strictly controlled because of their high potential for abuse. State and federal laws authorize prescribing drugs in Schedules II through V; most Schedule I drugs do not have any approved medical use.

COMMITTEE ACTION

General Law Committee

Joint Favorable