Relates to applicant registration for wholesalers or manufacturers of prescription drugs and unlawful transactions by manufacturers and wholesalers.
Sponsor: LANZA Committee: HIGHER EDUCATION
Law Section: Education Law
Law: Amd SS6808 & 6824, add S6810-a, Ed L
Law Section: Education Law
Law: Amd SS6808 & 6824, add S6810-a, Ed L
- Feb 27, 2012: PRINT NUMBER 5286A
- Feb 27, 2012: AMEND AND RECOMMIT TO HIGHER EDUCATION
- Jan 4, 2012: REFERRED TO HIGHER EDUCATION
- May 3, 2011: REFERRED TO HIGHER EDUCATION
BILL NUMBER:S5286 TITLE OF BILL: An act to amend the education law, in relation to wholesalers and manufacturers of prescription drugs PURPOSE: To strengthen the requirements for registration as a wholesaler or manufacturer and to provide penalties for selling or distributing counterfeit drugs. SUMMARY OF PROVISIONS: Section one amends subparagraph 2 of paragraph a of subdivision 4 of section 6808 of the education law, as amended by chapter 62 of the laws of 1989, by increasing the application fee that shall accompany the registration for a wholesaler or manufacturer to one thousand two hundred dollars from the current eight hundred twenty-five dollars. Section two amends paragraphs b and d of subdivision 4 of section 6808 of the education law, paragraph b as amended by chapter 538 of the laws of 2001 and paragraph d as amended by chapter 62 of the laws of 1989. Paragraph b is amended by providing that the triennial registration fee that is paid by wholesalers and manufacturers shall be increased to eight hundred dollars, from five hundred twenty dollars, or a pro rated portion as determined by the department of education. Paragraph d provides that in the event that the location of a business changes, the fee for inspection and endorsement shall be increased to three hundred dollars from the current one hundred seventy dollars. Section three amends subdivision 4 of section 6808 of the education law by adding six new paragraphs e, f, g, h, i and j. Paragraph e provides that any applicant for registration as a wholesaler or manufacturer shall be of good moral character, as determined by the department of education. Such requirements shall extend to all persons responsible for the distribution of a prescription drug for the applicant as determined by the department. Paragraph f provides that upon receipt of an application for registration, the commissioner shall initiate a criminal history records search of any of the persons identified in paragraph e. Prior to conducting the criminal history records search and fingerprinting process, the commissioner shall obtain the applicant's consent to the criminal history records search. The commissioner shall obtain two sets of fingerprints from each applicant and any fees necessary to process such fingerprints. The commissioner shall promptly transmit the fingerprints to the division of criminal justice services which shall submit the fingerprints to the federal bureau of investigation for a. national criminal history record check. Such criminal history record will be considered. for the purpose of establishing good moral character. "Criminal history record" is defined. All such criminal history records shall be confidential. The commissioner is authorized to charge the applicant additional fees for the criminal history record search. Paragraph g provides additional duties of the commissioner and the department, such as promulgating a form to be provided to all applicants for registration purposes. The department shall obtain the signed, informed consent of each individual identified in this section of the applicant with regard to obtaining and reviewing such individual's criminal history information. Specifics of such consent form are outlined. Paragraph h provides that every wholesaler shall submit a performance or surety bond of not less than one hundred thousand dollars to the department to ensure compliance with the provisions of this article. The department may waive such bond for certain not-for-profit entities or certain other wholesalers. Paragraph i provides that the department may promulgate rules and regulations to exempt from the requirements of paragraphs e, f, g and h a wholesaler that has received accreditation from a nationally recognized accreditation body approved by the commissioner and that meets the licensing standards under this subdivision. Paragraph j provides that the commissioner shall exempt certain manufacturers from the requirements of paragraphs e, f, g and h in the event that such requirements are not required by federal law or regulation, unless the commissioner determines that such requirements are necessary to prevent a risk to prescription drug distribution in the state. Section four amends the education law by adding a new section 6810-a that provides certain acts which shall be considered unlawful if committed by a manufacturer, wholesaler or other person: intentionally packaging, selling, transferring, distributing or delivering any prescription drug that he or she knows to be adulterated, misbranded, counterfeit or has been rendered unfit for distribution; and intentionally packaging, selling, transferring, distributing or delivering a prescription drug to any wholesaler who is not licensed or registered pursuant to this article. Section four further provides that it shall be a class D felony for any person who violates this section. Additionally, any drug packaged, sold, transferred, distributed or delivered in violation of this section shall be contraband and subject to seizure by the board of pharmacy, the department of health or any law enforcement officer of this state. Section five amends section 6824 of the education law, as added by chapter 987 of the laws of 1971, by adding a violation of any provision of section sixty-eight hundred ten-a of this article to the list of violations for which the secretary is authorized to apply to a court for an injunction. Section six provides the effective date. JUSTIFICATION: The marketing of counterfeit drugs has become prevalent throughout the United States as well as around the world. The World Health Organization (WHO) estimates that counterfeit drugs make up 10% of all drugs sold worldwide, with the percentage much higher in developing countries. January 2009 Report by the American Council on Science and Health, "Counterfeit Drugs: Coming to a Pharmacy Near You with an Update for 2009" (ACSH 2009 Report). According to the National Association of Boards of Pharmacy (NABP), counterfeit drug sales accounted for $75 billion in global sales in 2010, with an estimated 1 to 2 percent of drugs in North America being counterfeit. Moreover, counterfeit drugs have contributed to the increasing drug resistance of the most deadly infectious diseases such as HIV/AIDS, tuberculosis and malaria. Despite the view that the U.S. drug supply is among the most secure in the world, the growing size and sophistication of counterfeit, drug rings have allowed them to penetrate the legitimate drug supplies of the United States. In the last five years, counterfeit drug investigations by the Office of Criminal Investigations of the Food and Drug Administration (FDA) increased almost ten-fold, from 6 in 2000 to 59 in 2004. If we accept the NABP's estimate that 1-2% of drugs sold in North America are counterfeit (compared to a WHO estimate of 5% to 7% in the United States), the odds are, conservatively, 1 in 100 that the drug a consumer receives at a pharmacy in the U.S. is counterfeit and that out of the approximately 3.7 billion prescriptions filled in the U.S. this year, as many as 37 million may have been filled with counterfeit versions. There is, however, no way to know the true degree to which counterfeit drugs have contaminated our drug supply. Most of the incidents go undetected since the evidence is usually destroyed when the drug is consumed and the results of taking the counterfeit drug are blamed on other causes, such as incorrect diagnosis, or in the case of HIV/AIDS further complications and death are expected. Recently, two highly publicized examples of counterfeit drugs come to mind: Lipitor tablets used to lower cholesterol, where in 2005 in New York State alone, New Yorkers received an estimated 100,000 dosage units of counterfeit Lipitor; and Procrit, an injectable drug used to stimulate red blood cell growth to treat severe anemia and anemia related to treatment for HIV/AIDS. There have been cases of counterfeits of other well-known brands as well as drugs used to. treat critically-ill patients in the U.S. in the last few years to hundreds of thousands of unwitting patients, including: * Combivir, used to prolong the life of HIV/AIDS patients by preventing the virus from reproducing--replaced with another HIV medication that can cause fatal allergic reactions * Serostim, a human growth hormone used to prevent HIV/AIDS patients from wasting-replaced with dangerous levels of a fertility drug * Celebrex, used to treat arthritis--replaced with vitamins * Viagra, used to treat impotence--over 700,000 counterfeit pills were manufactured * Zyprexa, used to help prevent hallucinations and delusions in schizophrenic and bipolar patients--replaced with aspirin * Neupogen, an injectable used to boost the immune system of cancer patients-replaced with saline ACSH 2009 Report. In addition; there have been multiple incidents involving counterfeit versions of Tamiflu, used to treat seasonal or avian flu. Aside from the obvious direct result of receiving the counterfeit medicine, treatment from counterfeit versions may also increase the risk of causing the virus to develop a resistance to the Tamiflu drug. The nature of the drug supply system in the U.S. makes our drugs ripe for diversion and counterfeiting. The path of a drug from manufacturer to distributor to pharmacy more often than not is not a single or linear one; in fact, a substantial portion of our drugs flow through a complex network of distributors, intermediaries and secondary wholesalers. Recognizing the need to assure the safe and effective distribution of prescription drugs, Congress enacted more than 20 years ago the Prescription Drug Manufacturing Act (PDMA) which, among other things, imposed a requirement on wholesale distributors to maintain either a paper or electronic pedigree of prescription drugs. Pending development of appropriate technology to facilitate the establishment of an electronic pedigree for prescription drugs, and thereby allow us to track and trade prescription drugs through the supply chain, the FDA has stated that all levels of government, in addition to the private sector, should take responsibility for ensuring the safety and security of the U.S. drug distribution system. Counterfeit Drug Task Report February 2004 Update, 2009. At the State level, the Update noted that it would be beneficial for states to strengthen their provisions governing wholesale distribution. The Update further reported that the FDA planned to pursue increased criminal penalties for counterfeiting in the United States Sentencing Commissions sentencing guidelines. To date, thirty six states have strengthened licensure requirements of wholesalers through legislation and/or regulations. To better secure the drug supply system pending implementation of federal law, we must adopt at the state level a multi-layered strategy that combines strengthening the licensing requirements of wholesalers and increasing penalties for those who violate the law so that our regulatory and enforcement agencies have the authority to carry out the law. Ensuring that all persons and entities involved in the wholesale distribution of drug products meet stringent licensing criteria and maintain high ethical and business standards is critical. This bill toughens the licensing requirements of manufacturers and wholesalers by, among other things, carrying out criminal background checks of responsible individuals and requiring significant surety bonds, decreasing the likelihood that corrupt, "fly-by-night" operations will be able to infiltrate the supply chain and adulterate or taint the prescription drugs. Without enacting legislation at the state level to address the weaknesses inherent in our drug supply system, we will continue to leave the public vulnerable to individuals who are willing to harm, and even kill, people for profit. LEGISLATIVE HISTORY: Similar to A.6546-A, 2009 and 2010 referred to higher education. Similar to A.7810-C, 2007 and 2008 referred to higher education. Same as S.5290-C, 2007 and 2008 referred to health. Similar to A.2957-A, 2005 and 2006 referred to higher education. Same as S.3278-A, 2005 passed senate and 2006 referred to higher education. FISCAL. IMPLICATIONS: None to the state. EFFECTIVE DATE: This act shall take effect on the one hundred and eightieth day after it shall have become law.
S T A T E O F N E W Y O R K ________________________________________________________________________ 5286 2011-2012 Regular Sessions I N SENATE May 3, 2011 ___________ Introduced by Sen. LANZA -- read twice and ordered printed, and when printed to be committed to the Committee on Higher Education AN ACT to amend the education law, in relation to wholesalers and manufacturers of prescription drugs THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM- BLY, DO ENACT AS FOLLOWS:
Section 1. Subparagraph 2 of paragraph a of subdivision 4 of section 6808 of the education law, as amended by chapter 62 of the laws of 1989, is amended to read as follows:
(2) The application shall be accompanied by a fee of [
eight hundred twenty-five] TWELVE HUNDRED dollars. S 2. Paragraphs b and d of subdivision 4 of section 6808 of the educa- tion law, paragraph b as amended by chapter 538 of the laws of 2001 and paragraph d as amended by chapter 62 of the laws of 1989, are amended to read as follows:
b. Renewal of registration. All wholesalers' and manufacturers' regis- trations shall be renewed on dates set by the department. The triennial registration fee shall be [
five hundred twenty] EIGHT HUNDRED dollars or a pro rated portion thereof as determined by the department. d. Change of location. In the event that the location of such place of business shall be changed, the owner shall apply to the department for inspection of the new location and endorsement of the registration for the new location. The fee for inspection and endorsement shall be [ one hundred seventy] THREE HUNDRED dollars, unless it appears to the satis- faction of the department that the change in location is of a temporary nature due to fire, flood or other disaster. S 3. Subdivision 4 of section 6808 of the education law is amended by adding six new paragraphs e, f, g, h, i and j to read as follows:
E. APPLICANT REGISTRATION. ANY APPLICANT FOR REGISTRATION AS A WHOLE- SALER OR MANUFACTURER SHALL BE OF GOOD MORAL CHARACTER, AS DETERMINED BY THE DEPARTMENT. THE REQUIREMENTS SHALL EXTEND TO ALL PERSONS RESPONSI- EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets [ ] is old law to be omitted. LBD06282-01-1 S. 5286 2 BLE FOR THE DISTRIBUTION OF A PRESCRIPTION DRUG FOR THE APPLICANT, AS DETERMINED BY THE DEPARTMENT. SUBJECT TO THE PROVISIONS OF PARAGRAPHS F AND G OF THIS SUBDIVISION, THE DEPARTMENT SHALL REQUIRE PHOTOGRAPHS, CRIMINAL HISTORY RECORDS SEARCH AND FINGERPRINTS. F. CRIMINAL HISTORY RECORDS SEARCH. (1) UPON RECEIPT OF AN APPLICATION FOR REGISTRATION PURSUANT TO THIS SUBDIVISION, THE COMMISSIONER SHALL, SUBJECT TO THE RULES AND REGULATIONS OF THE DIVISION OF CRIMINAL JUSTICE SERVICES, INITIATE A CRIMINAL HISTORY RECORDS SEARCH OF THE PERSONS IDENTIFIED IN PARAGRAPH E OF THIS SUBDIVISION. PRIOR TO INITIATING THE BACKGROUND CHECKS AND FINGERPRINTING PROCESS, THE COMMISSIONER SHALL FURNISH THE APPLICANT WITH THE FORM DESCRIBED IN PARAGRAPH G OF THIS SUBDIVISION AND SHALL OBTAIN THE APPLICANT'S CONSENT TO THE CRIMINAL HISTORY RECORDS SEARCH. THE COMMISSIONER SHALL OBTAIN FROM EACH APPLI- CANT TWO SETS OF FINGERPRINTS AND THE DIVISION OF CRIMINAL JUSTICE SERVICES PROCESSING FEE IMPOSED PURSUANT TO SUBDIVISION EIGHT-A OF SECTION EIGHT HUNDRED THIRTY-SEVEN OF THE EXECUTIVE LAW AND ANY FEE IMPOSED BY THE FEDERAL BUREAU OF INVESTIGATION FOR A NATIONAL CRIMINAL HISTORY RECORD CHECK. THE COMMISSIONER SHALL PROMPTLY TRANSMIT SUCH FINGERPRINTS AND FEES TO THE DIVISION OF CRIMINAL JUSTICE SERVICES FOR ITS FULL SEARCH AND RETAIN PROCESSING. THE DIVISION OF CRIMINAL JUSTICE SERVICES IS AUTHORIZED TO SUBMIT THE FINGERPRINTS AND THE APPROPRIATE FEE TO THE FEDERAL BUREAU OF INVESTIGATION FOR A NATIONAL CRIMINAL HISTORY RECORD CHECK. THE DIVISION OF CRIMINAL JUSTICE SERVICES AND THE FEDERAL BUREAU OF INVESTIGATION SHALL FORWARD SUCH CRIMINAL HISTORY RECORD TO THE COMMISSIONER IN A TIMELY MANNER. THE RELEASE OF SUCH CRIM- INAL HISTORY RECORD BY THE DIVISION OF CRIMINAL JUSTICE SERVICES SHALL BE SUBJECT TO THE PROVISIONS OF SUBDIVISION SIXTEEN OF SECTION TWO HUNDRED NINETY-SIX OF THE EXECUTIVE LAW. THE COMMISSIONER SHALL CONSIDER SUCH CRIMINAL HISTORY RECORD IN ACCORDANCE WITH THE REQUIREMENTS OF ARTICLE TWENTY-THREE-A OF THE CORRECTION LAW, FOR THE PURPOSE OF ESTAB- LISHING THE GOOD MORAL CHARACTER OF AN INDIVIDUAL AS REQUIRED IN PARA- GRAPH E OF THIS SUBDIVISION. (2) FOR THE PURPOSES OF THIS SECTION THE TERM "CRIMINAL HISTORY RECORD" SHALL MEAN A RECORD OF ALL CONVICTIONS OF CRIMES AND ANY PENDING CRIMINAL CHARGES MAINTAINED ON AN INDIVIDUAL BY THE DIVISION OF CRIMINAL JUSTICE SERVICES AND THE FEDERAL BUREAU OF INVESTIGATION. FURTHERMORE, UPON NOTIFICATION THAT SUCH APPLICANT HAS BEEN REGIS- TERED, THE DIVISION OF CRIMINAL JUSTICE SERVICES SHALL HAVE THE AUTHORI- TY TO PROVIDE SUBSEQUENT CRIMINAL HISTORY NOTIFICATIONS DIRECTLY TO THE COMMISSIONER. ALL SUCH CRIMINAL HISTORY RECORDS PROCESSED AND SENT PURSUANT TO THIS SUBDIVISION SHALL BE CONFIDENTIAL PURSUANT TO THE APPLICABLE FEDERAL AND STATE LAWS, RULES AND REGULATIONS, AND SHALL NOT BE PUBLISHED OR IN ANY WAY DISCLOSED TO PERSONS OTHER THAN THE COMMIS- SIONER, UNLESS OTHERWISE AUTHORIZED BY LAW. (3) NOTWITHSTANDING ANY OTHER PROVISION OF LAW TO THE CONTRARY, THE COMMISSIONER IS AUTHORIZED TO CHARGE ADDITIONAL FEES TO APPLICANTS FOR REGISTRATION IN AN AMOUNT EQUAL TO THE FEES ESTABLISHED PURSUANT TO LAW BY THE DIVISION OF CRIMINAL JUSTICE SERVICES AND THE FEDERAL BUREAU OF INVESTIGATION FOR THE CRIMINAL HISTORY RECORD SEARCHES MANDATED BY THIS SUBDIVISION. G. ADDITIONAL DUTIES OF THE COMMISSIONER AND DEPARTMENT. (1) THE COMMISSIONER, IN COOPERATION WITH THE DIVISION OF CRIMINAL JUSTICE SERVICES AND IN ACCORDANCE WITH ALL APPLICABLE PROVISIONS OF LAW, SHALL PROMULGATE RULES AND REGULATIONS TO REQUIRE THE FINGERPRINTING OF THE INDIVIDUALS IDENTIFIED IN PARAGRAPH E OF THIS SUBDIVISION, AND FOR THE USE OF INFORMATION DERIVED FROM SEARCHES OF THE RECORDS OF THE DIVISION S. 5286 3 OF CRIMINAL JUSTICE SERVICES AND THE FEDERAL BUREAU OF INVESTIGATION BASED ON THE USE OF SUCH FINGERPRINTS, AS PROVIDED IN PARAGRAPH F OF THIS SUBDIVISION. (2) THE COMMISSIONER, IN COOPERATION WITH THE DIVISION OF CRIMINAL JUSTICE SERVICES, SHALL PROMULGATE A FORM TO BE PROVIDED TO ALL APPLI- CANTS FOR REGISTRATION PURSUANT TO THIS SUBDIVISION THAT SHALL:
(I) INFORM THE PROSPECTIVE APPLICANT THAT THE COMMISSIONER IS REQUIRED TO REQUEST HIS OR HER CRIMINAL HISTORY INFORMATION FROM THE DIVISION OF CRIMINAL JUSTICE SERVICES AND THE FEDERAL BUREAU OF INVESTIGATION AND REVIEW SUCH INFORMATION PURSUANT TO THIS SECTION, AND PROVIDE A DESCRIPTION OF THE MANNER IN WHICH HIS OR HER FINGERPRINT CARDS WILL BE USED UPON SUBMISSION TO THE DIVISION OF CRIMINAL JUSTICE SERVICES; AND (II) INFORM THE PROSPECTIVE APPLICANT THAT HE OR SHE HAS THE RIGHT TO OBTAIN, REVIEW AND SEEK CORRECTION OF HIS OR HER CRIMINAL HISTORY INFOR- MATION PURSUANT TO REGULATIONS AND PROCEDURES ESTABLISHED BY THE DIVI- SION OF CRIMINAL JUSTICE SERVICES. (3) THE DEPARTMENT SHALL OBTAIN THE SIGNED, INFORMED CONSENT OF EACH INDIVIDUAL IDENTIFIED IN PARAGRAPH E OF THIS SUBDIVISION, ON SUCH FORM SUPPLIED BY THE COMMISSIONER, WHICH INDICATES THAT SUCH PERSON HAS:
(I) BEEN INFORMED OF THE RIGHTS AND PROCEDURES NECESSARY TO OBTAIN, REVIEW AND SEEK CORRECTION OF HIS OR HER CRIMINAL HISTORY INFORMATION; (II) BEEN INFORMED OF THE REASON FOR THE REQUEST FOR HIS OR HER CRIMI- NAL HISTORY INFORMATION; (III) CONSENTED TO SUCH REQUEST FOR A REPORT; (IV) SUPPLIED ON THE FORM A CURRENT MAILING OR HOME ADDRESS FOR SUCH INDIVIDUAL; (V) BEEN INFORMED THAT HE OR SHE MAY WITHDRAW HIS OR HER CONSENT, REGARDLESS OF WHETHER THE DEPARTMENT HAS REVIEWED SUCH INDIVIDUAL'S CRIMINAL HISTORY INFORMATION; (VI) BEEN INFORMED THAT IN THE EVENT THE WHOLESALER'S OR MANUFACTUR- ER'S REGISTRATION PURSUANT TO THIS SUBDIVISION HAS EXPIRED OR OTHERWISE TERMINATED, THE COMMISSIONER SHALL NOTIFY THE DIVISION OF CRIMINAL JUSTICE SERVICES OF SUCH EXPIRATION OR TERMINATION, AND THE DIVISION OF CRIMINAL JUSTICE SERVICES SHALL DESTROY THE FINGERPRINTS OF THE INDIVID- UAL OR INDIVIDUALS ASSOCIATED WITH SUCH WHOLESALER'S OR MANUFACTURER'S REGISTRATION; AND (VII) BEEN INFORMED OF THE MANNER IN WHICH HE OR SHE MAY SUBMIT TO THE COMMISSIONER ANY INFORMATION THAT MAY BE RELEVANT TO THE CONSIDERATION OF THE APPLICANT'S REGISTRATION INCLUDING, WHERE APPLICABLE, INFORMATION IN SUPPORT OF HIS OR HER GOOD MORAL CHARACTER OR REHABILITATION THEREOF. H. PERFORMANCE OR SURETY BOND. EVERY WHOLESALER SHALL SUBMIT A PERFORMANCE OR SURETY BOND OF NOT LESS THAN ONE HUNDRED THOUSAND DOLLARS TO THE DEPARTMENT TO ENSURE COMPLIANCE WITH THE PROVISIONS OF THIS ARTI- CLE, EXCEPT THAT THE DEPARTMENT MAY WAIVE SUCH BOND FOR CERTAIN NOT-FOR-PROFIT ENTITIES SUCH AS HOSPITALS AND CORRECTIONAL FACILITIES THAT LIMIT DISTRIBUTION TO THEIR OWN FACILITIES AND DO NOT RETURN SUCH MEDICATIONS TO OTHER ENTITIES. SUCH WAIVER SHALL BE MADE ON THE RECOM- MENDATION OF THE STATE BOARD OF PHARMACY. THE DEPARTMENT MAY ALSO EXEMPT A WHOLESALER FROM THE SURETY BOND REQUIREMENT WHEN SUCH WHOLESALER IS OWNED AND OPERATED BY A FACILITY, SUBJECT TO THE PROVISIONS OF ARTICLE TWENTY-EIGHT OF THE PUBLIC HEALTH LAW AND OTHER FACILITIES GOVERNED BY A STATE AGENCY THAT LIMITS ITS DISTRIBUTION OF PRESCRIPTION DRUGS TO FACILITIES AND PRACTITIONERS WITHIN THE INSTITUTION'S NETWORK AND OPER- ATIONS AND DOES NOT SELL OR RETURN SUCH MEDICATIONS TO MANUFACTURERS OR TO OTHER WHOLESALERS. S. 5286 4 I. WHOLESALER REGISTRATION. THE DEPARTMENT MAY PROMULGATE RULES AND REGULATIONS TO EXEMPT FROM THE REQUIREMENTS OF PARAGRAPHS E, F, G AND H OF THIS SUBDIVISION A WHOLESALER THAT HAS RECEIVED ACCREDITATION FROM A NATIONALLY RECOGNIZED ACCREDITATION BODY APPROVED BY THE COMMISSIONER AND THAT MEETS THE LICENSING STANDARDS UNDER THIS SUBDIVISION. THE STAN- DARDS SHALL BE DEFINED BY THE COMMISSIONER PURSUANT TO REGULATIONS. J. MANUFACTURER REGISTRATION. NOTWITHSTANDING THE REQUIREMENTS FOR REGISTRATION UNDER THIS SUBDIVISION, THE COMMISSIONER SHALL EXEMPT A MANUFACTURER LICENSED OR APPROVED BY THE FEDERAL FOOD AND DRUG ADMINIS- TRATION (FDA) OR ITS SUCCESSOR AGENCY TO MANUFACTURE DRUGS OR DEVICES WITH REGARD TO SUCH DRUGS OR DEVICES FROM THE REQUIREMENTS OF PARAGRAPHS E, F, G AND H OF THIS SUBDIVISION IN THE EVENT THAT SUCH REQUIREMENTS ARE NOT REQUIRED BY FEDERAL LAW OR REGULATION UNLESS THE COMMISSIONER DETERMINES THAT SUCH REQUIREMENTS ARE NECESSARY TO PREVENT A RISK TO PRESCRIPTION DRUG DISTRIBUTION IN THE STATE. S 4. The education law is amended by adding a new section 6810-a to read as follows:
S 6810-A. UNLAWFUL TRANSACTIONS BY MANUFACTURERS AND WHOLESALERS. IT SHALL BE UNLAWFUL FOR A MANUFACTURER, WHOLESALER OR OTHER PERSON TO:
1. INTENTIONALLY PACKAGE, SELL, TRANSFER, DISTRIBUTE OR DELIVER ANY PRESCRIPTION DRUG THAT HE OR SHE KNOWS IS ADULTERATED, MISBRANDED, COUN- TERFEIT OR HAS OTHERWISE BEEN RENDERED UNFIT FOR DISTRIBUTION. 2. INTENTIONALLY PACKAGE, SELL, TRANSFER, DISTRIBUTE OR DELIVER A PRESCRIPTION DRUG TO ANY WHOLESALER WHO IS NOT LICENSED OR REGISTERED PURSUANT TO THIS ARTICLE. A PERSON WHO VIOLATES THIS SECTION SHALL BE GUILTY OF A CLASS D FELO- NY. IN ADDITION, ANY DRUG PACKAGED, SOLD, TRANSFERRED, DISTRIBUTED OR DELIVERED IN VIOLATION OF THIS SECTION SHALL BE CONTRABAND AND SUBJECT TO SEIZURE BY THE BOARD OF PHARMACY, THE DEPARTMENT OF HEALTH OR ANY LAW ENFORCEMENT OFFICER OF THE STATE. S 5. Section 6824 of the education law, as added by chapter 987 of the laws of 1971, is amended to read as follows:
S 6824. Injunction proceedings. In addition to the remedies hereinaft- er provided, the secretary is hereby authorized to apply to the court of the proper venue for an injunction to restrain any person from (a) introducing or causing to be introduced into commerce any adulterated or misbranded drug, device or cosmetic; or (b) from introducing or causing to be introduced in commerce any new drug which does not comply with the provisions of this article; or (c) from disseminating or causing to be disseminated a false advertisement; OR (D) VIOLATING ANY PROVISION OF SECTION SIXTY-EIGHT HUNDRED TEN-A OF THIS ARTICLE, without being compelled to allege or prove that an adequate remedy at law does not exist. S 6. This act shall take effect on the one hundred eightieth day after it shall have become a law.