PRINTER'S NO. 427
No. 311 Session of 2007
INTRODUCED BY RAFFERTY, STACK, BOSCOLA, KITCHEN, FONTANA, ERICKSON, WONDERLING, ORIE, COSTA AND LOGAN, MARCH 13, 2007
REFERRED TO PUBLIC HEALTH AND WELFARE, MARCH 13, 2007
AN ACT 1 Requiring the licensing of secondary wholesalers and a written 2 pedigree for use in tracking drugs through the supply chain 3 and in identifying counterfeit prescription drugs; imposing 4 duties and responsibilities upon the Department of Health and 5 the State Board of Pharmacy; and prescribing penalties. 6 The General Assembly of the Commonwealth of Pennsylvania 7 hereby enacts as follows: 8 Section 1. Short title. 9 This act shall be known and may be cited as the Wholesale and 10 Prescription Medication Integrity Act. 11 Section 2. Definitions. 12 The following words and phrases when used in this act shall 13 have the meanings given to them in this section unless the 14 context clearly indicates otherwise: 15 "Authentication." Affirmative verification, before any 16 wholesale distribution of a prescription drug, that each 17 transaction listed on the pedigree has occurred. 18 "Authorized distributor of record." A wholesale distributor 19 with whom a manufacturer has established an ongoing relationship
1 to distribute the manufacturer's prescription drug. An ongoing 2 relationship is deemed to exist between such wholesale 3 distributor and a manufacturer when the wholesale distributor, 4 including any affiliated group of the wholesale distributor, as 5 defined in section 1504 of the Internal Revenue Code of 1986 6 (Public Law 99-514, 26 U.S.C § 1 et seq.), complies with the 7 following: 8 (1) the wholesale distributor has a written agreement 9 currently in effect with the manufacturer evidencing such 10 ongoing relationship; and 11 (2) the wholesale distributor is listed on the 12 manufacturer's current list of authorized distributors of 13 record, which is updated by the manufacturer on no less than 14 a monthly basis. 15 "Chain pharmacy warehouse." A physical location for 16 prescription drugs that acts as a central warehouse and performs 17 intracompany sales or transfers of the drugs to a group of chain 18 pharmacies having the same common ownership and control. 19 "Colicensed partner or product." A situation in which two or 20 more parties have the right to engage in the manufacturing or 21 marketing, or both, of a prescription drug, consistent with 22 United States Food and Drug Administration's implementation of 23 the Prescription Drug Marketing Act of 1987 (Public Law 100-293, 24 102 Stat. 95). 25 "Drop shipment." The sale of a prescription drug to a 26 wholesale distributor by the manufacturer of the prescription 27 drug, the manufacturer's colicensed product partner, the 28 manufacturer's third-party logistics provider or the 29 manufacturer's exclusive distributor, whereby the wholesale 30 distributor or chain pharmacy warehouse takes title but not 20070S0311B0427 - 2 -
1 physical possession of such prescription drug and the wholesale 2 distributor invoices the pharmacy or chain pharmacy warehouse or 3 another person authorized by law to dispense or administer such 4 drug to a patient, and the pharmacy or chain pharmacy warehouse 5 or other authorized person receives delivery of the prescription 6 drug directly from the manufacturer, the manufacturer's third- 7 party logistics provider or the manufacturer's exclusive 8 distributor. 9 "Facility." A facility of a wholesale distributor where 10 prescription drugs are stored, handled, repackaged or offered 11 for sale. 12 "FDA." The United States Food and Drug Administration. 13 "Manufacturer." A person licensed or approved by the United 14 States Food and Drug Administration to engage in the manufacture 15 of drugs or devices, consistent with its definition of 16 "manufacturer" under its regulations and guidances implementing 17 the Prescription Drug Marketing Act of 1987 (Public Law 100-293, 18 102 Stat. 95). 19 "Manufacturer's exclusive distributor." Anyone who contracts 20 with a manufacturer to provide or coordinate warehousing, 21 distribution or other services on behalf of a manufacturer and 22 who takes title to that manufacturer's prescription drug but 23 does not have general responsibility to direct the sale or 24 disposition of the prescription drug. The manufacturer's 25 exclusive distributor must be licensed as a wholesale 26 distributor under this act, and to be considered part of the 27 normal distribution channel must also be an authorized 28 distributor of record. 29 "Normal distribution channel." A chain of custody for a 30 prescription drug that goes, directly or by drop shipment, from 20070S0311B0427 - 3 -
1 a manufacturer of the prescription drug, from that manufacturer 2 to the manufacturer's colicensed partner, from that manufacturer 3 to the manufacturer's third-party logistics provider or from 4 that manufacturer to the manufacturer's exclusive distributor to 5 any of the following: 6 (1) a pharmacy, then to a patient or other designated 7 persons authorized by law to dispense or administer the drug 8 to a patient; 9 (2) a wholesale distributor, then to a pharmacy, then to 10 a patient or other designated persons authorized by law to 11 dispense or administer the drug to a patient; 12 (3) a wholesale distributor, then to a chain pharmacy 13 warehouse, then to that chain pharmacy warehouse's 14 intracompany pharmacy, then to a patient or other designated 15 persons authorized by law to dispense or administer such drug 16 to a patient; or 17 (4) a chain pharmacy warehouse, then to the chain 18 pharmacy warehouse's intracompany pharmacy, then to a patient 19 or other designated persons authorized by law to dispense or 20 administer such drug to a patient. 21 "Pedigree." A document or electronic file containing 22 information that records each distribution of any given 23 prescription drug. 24 "Prescription drug." Any drug, including any biological 25 product, except blood and blood components intended for 26 transfusion or biological products that are also medical 27 devices, required by Federal law or regulation to be dispensed 28 only by a prescription, including finished dosage forms and bulk 29 drug substances subject to section 503(b) of the Federal Food, 30 Drug, and Cosmetic Act (52 Stat. 1040, 21 U.S.C. § 353(b)). 20070S0311B0427 - 4 -
1 "Repackage." Repackaging or otherwise changing the 2 container, wrapper or labeling to further the distribution of a 3 prescription drug, excluding that completed by the pharmacists 4 responsible for dispensing product to the patient. 5 "Repackager." A person who repackages. 6 "State licensing authority." The Department of Health. 7 "Wholesale distribution." The term does not include: 8 (1) Intracompany sales of prescription drugs, meaning 9 any transaction or transfer between any division, subsidiary, 10 parent or affiliated or related company under common 11 ownership and control of a corporate entity, or any 12 transaction or transfer between colicensees of a colicensed 13 product. 14 (2) The sale, purchase, distribution, trade or transfer 15 of a prescription drug or offer to sell, purchase, 16 distribute, trade or transfer a prescription drug for 17 emergency medical reasons. 18 (3) The distribution of prescription drug samples by 19 manufacturers' representatives. 20 (4) Drug returns, when conducted by a hospital, health 21 care entity or charitable institution in accordance with 21 22 C.F.R. § 203.23 (relating to returns). 23 (5) The sale of minimal quantities of prescription drugs 24 by retail pharmacies to licensed practitioners for office 25 use. 26 (6) The sale, purchase or trade of a drug, an offer to 27 sell, purchase or trade a drug or the dispensing of a drug 28 pursuant to a prescription. 29 (7) The sale, transfer, merger or consolidation of all 30 or part of the business of a pharmacy or pharmacies from or 20070S0311B0427 - 5 -
1 with another pharmacy or pharmacies, whether accomplished as 2 a purchase and sale of stock or business assets. 3 (8) The sale, purchase, distribution, trade or transfer 4 of a prescription drug from one authorized distributor of 5 record to one additional authorized distributor of record 6 that the manufacturer has stated in writing to the receiving 7 authorized distributor of record that the manufacturer is 8 unable to supply such prescription drug and the supplying 9 authorized distributor of record states in writing that the 10 prescription drug being supplied had until that time been 11 exclusively in the normal distribution channel. 12 (9) The delivery of, or offer to deliver, a prescription 13 drug by a common carrier solely in the common carrier's usual 14 course of business of transporting prescription drugs, and 15 such common carrier does not store, warehouse or take legal 16 ownership of the prescription drug. 17 (10) The sale or transfer from a retail pharmacy or 18 chain pharmacy warehouse of expired, damaged, returned or 19 recalled prescription drugs to the original manufacturer or 20 to a third-party returns processor. 21 "Wholesale distributor." Anyone engaged in the wholesale 22 distribution of prescription drugs, including, but not limited 23 to, manufacturers; repackagers; own-label distributors; private- 24 label distributors; jobbers; brokers; warehouses, including 25 manufacturers' and distributors' warehouses, and drug 26 wholesalers or distributors; independent wholesale drug traders; 27 retail pharmacies that conduct wholesale distribution; and chain 28 pharmacy warehouses that conduct wholesale distribution. To be 29 considered part of the normal distribution channel the wholesale 30 distributor must also be an authorized distributor of record. 20070S0311B0427 - 6 -
1 Section 3. Wholesale drug distributor licensing requirements. 2 (a) Licensed required.--Every wholesale distributor who 3 engages in the wholesale distribution of prescription drugs must 4 be licensed by the State licensing authority in this 5 Commonwealth, and every nonresident wholesale distributor must 6 be licensed in this Commonwealth if it ships prescription drugs 7 into this Commonwealth, in accordance with this act before 8 engaging in wholesale distributions of wholesale prescription 9 drugs. The State licensing authority shall exempt manufacturers 10 distributing their own FDA-approved drugs and devices from any 11 licensing and other requirements, to the extent not required by 12 Federal law or regulation, unless particular requirements are 13 deemed necessary and appropriate following rulemaking. 14 (b) Requirements.--The State licensing authority shall 15 require the following minimum information from each wholesale 16 distributor applying for a license under subsection (a): 17 (1) The name, full business address and telephone number 18 of the licensee. 19 (2) All trade or business names used by the licensee. 20 (3) Addresses, telephone numbers and the names of 21 contact persons for all facilities used by the licensee for 22 the storage, handling and distribution of prescription drugs. 23 (4) The type of ownership or operation, such as a 24 partnership, corporation or sole proprietorship. 25 (5) The name of the owner or operator of the licensee, 26 including: 27 (i) If a person, the name of the person. 28 (ii) If a partnership, the name of each partner and 29 the name of the partnership. 30 (iii) If a corporation, the name and title of each 20070S0311B0427 - 7 -
1 corporate officer and director, the corporate names and 2 the name of the state of incorporation. 3 (iv) If a sole proprietorship, the full name of the 4 sole proprietor and the name of the business entity. 5 (6) A list of all licenses and permits issued to the 6 applicant by any other state that authorizes the applicant to 7 purchase or possess prescription drugs. 8 (7) The name of the applicant's designated 9 representative for the facility, together with the personal 10 information statement and fingerprints required pursuant to 11 paragraph (8) for such person. 12 (8) Each person required by paragraph (7) to provide a 13 personal information statement and fingerprints shall provide 14 the following information: 15 (i) The person's places of residence for the past 16 seven years. 17 (ii) The person's date and place of birth. 18 (iii) The person's occupations, positions of 19 employment and offices held during the past seven years. 20 (iv) The principal business and address of any 21 business, corporation or other organization in which each 22 such office of the person was held or in which each such 23 occupation or position of employment was carried on. 24 (v) Whether the person has been, during the past 25 seven years, the subject of any proceeding for the 26 revocation of any license and, if so, the nature of the 27 proceeding and the disposition of the proceeding. 28 (vi) Whether, during the past seven years, the 29 person has been enjoined, either temporarily or 30 permanently, by a court of competent jurisdiction from 20070S0311B0427 - 8 -
1 violating any Federal or State law regulating the 2 possession, control or distribution of prescription 3 drugs, together with details concerning any such event. 4 (vii) A description of any involvement by the person 5 with any business, including any investments, other than 6 the ownership of stock in a publicly traded company or 7 mutual fund during the past seven years, which 8 manufactured, administered, prescribed, distributed or 9 stored pharmaceutical products and any lawsuits in which 10 such businesses were named as a party. 11 (viii) A description of any felony criminal offense 12 of which the person, as an adult, was found guilty, 13 regardless of whether adjudication of guilt was withheld 14 or whether the person pled guilty or nolo contendere. If 15 the person indicates that a criminal conviction is under 16 appeal and submits a copy of the notice of appeal of that 17 criminal offense, the applicant must, within 15 days 18 after the disposition of the appeal, submit to the State 19 a copy of the final written order of disposition. 20 (ix) A photograph of the person taken in the 21 previous 30 days. 22 (c) Oath.--The information required pursuant to subsection 23 (b) shall be provided under oath. 24 (d) Prohibitions.--The State licensing authority shall not 25 issue a wholesale distributor license to an applicant unless the 26 State licensing authority: 27 (1) Conducts a physical inspection of the facility at 28 the required address provided by the applicant under 29 subsection (b)(1). 30 (2) Determines that the designated representative meets 20070S0311B0427 - 9 -
1 the following qualifications: 2 (i) Is 21 years of age or older. 3 (ii) Has been employed full time for at least three 4 years in a pharmacy or with a wholesale distributor in a 5 capacity related to the dispensing and distribution of 6 and recordkeeping relating to prescription drugs. 7 (iii) Is employed by the applicant full time in a 8 managerial level position. 9 (iv) Is actively involved in and aware of the actual 10 daily operation of the wholesale distributor. 11 (v) Is physically present at the facility of the 12 applicant during regular business hours, except when the 13 absence of the designated representative is authorized, 14 including, but not limited to, sick leave and vacation 15 leave. 16 (vi) Is serving in the capacity of a designated 17 representative for only one applicant at a time, except 18 where more than one licensed wholesale distributor is 19 colocated in the same facility and such wholesale 20 distributors are members of an affiliated group, as 21 defined in section 1504 of the Internal Revenue Code of 22 1986 (Public Law 99-514, 26 U.S.C. § 1 et seq.). 23 (vii) Does not have any convictions under any 24 Federal, State or local laws relating to wholesale or 25 retail prescription drug distribution or distribution of 26 controlled substances. 27 (viii) Does not have any felony convictions under 28 Federal, State or local laws. 29 (e) Fingerprints.--The State licensing authority shall 30 submit the fingerprints provided by a person with a license 20070S0311B0427 - 10 -
1 application for a Statewide criminal record check and for 2 forwarding to the Federal Bureau of Investigation for a national 3 criminal record check of the person. 4 (f) Bond.--The State licensing authority shall require every 5 wholesale distributor applying for a license to submit a bond of 6 at least $100,000, or other equivalent acceptable means of 7 security, such as an irrevocable letter of credit or a deposit 8 in a trust account or financial institution, payable to the 9 restricted account established pursuant to subsection (g). Chain 10 pharmacy warehouses that are engaged only in intracompany 11 transfers are exempt from the bond requirement. The purpose of 12 the bond is to secure payment of any fines or penalties and fees 13 and costs incurred regarding that license, which are authorized 14 by law and which the licensee fails to pay 30 days after the 15 fines, penalties or costs become final. The Commonwealth may 16 make a claim against such bond or security until one year after 17 the licensee's license ceases to be valid. The bond shall cover 18 all facilities operated by the applicant. 19 (g) Restricted account.--There is established within the 20 Department of Health a restricted account, separate from other 21 accounts, in which to deposit the wholesale distributor bonds 22 required by subsection (f). 23 (h) Multiple facilities.--If a wholesale distributor 24 distributes prescription drugs from more than one facility, the 25 wholesale distributor shall obtain a license for each facility. 26 (i) Corrections.--Every calendar year, the State licensing 27 authority shall send to each wholesale distributor licensed 28 under this act a form setting forth the information that the 29 wholesale distributor provided pursuant to this section. Within 30 30 days of receiving the form, the wholesale distributor shall 20070S0311B0427 - 11 -
1 identify and state under oath all changes or corrections to the 2 information that was provided. Changes and corrections shall be 3 submitted as required. The State licensing authority may suspend 4 or revoke the license of a wholesale distributor if the 5 wholesale distributor no longer qualifies for a license. 6 (j) Designated representative.--The designated 7 representative identified pursuant to subsection (b)(7) shall 8 complete continuing education programs as required by the State 9 licensing authority regarding Federal and State laws governing 10 wholesale distribution of prescription drugs. 11 (k) Nondisclosure.--Information provided under this section 12 shall not be disclosed to any person or entity other than the 13 State licensing authority, a government board or a government 14 agency. 15 Section 4. Restrictions on transactions. 16 (a) Purchases and receipts from pharmacies.--A wholesale 17 distributor shall receive prescription drug returns or exchanges 18 from a pharmacy or chain pharmacy warehouse pursuant to the 19 terms and conditions of the agreement between the wholesale 20 distributor and the pharmacy or chain pharmacy warehouse, 21 including the returns of expired, damaged and recalled 22 pharmaceutical product to either the original manufacturer or a 23 third-party returns processor, and such returns or exchanges 24 shall not be subject to the pedigree requirement of this act so 25 long as they are exempt from pedigree under FDA's currently 26 applicable Prescription Drug Marketing Act of 1987 (Public Law 27 100-293, 102 Stat. 95) guidance. Wholesale distributors and 28 pharmacies shall be held accountable for administering their 29 returns process and ensuring that their operations are secure 30 and do not permit entry of adulterated or counterfeit products. 20070S0311B0427 - 12 -
1 (b) Sale, distribution or transfer to an unlicensed 2 person.--A manufacturer or wholesale distributor shall furnish 3 prescription drugs only to a person licensed by the State 4 licensing authority. Before furnishing prescription drugs to a 5 person not known to the manufacturer or wholesale distributor, 6 the manufacturer or wholesale distributor shall affirmatively 7 verify that the person is legally authorized to receive the 8 prescription drugs by contacting the State licensing authority. 9 (c) Delivery.--Prescription drugs furnished by a 10 manufacturer or wholesale distributor shall be delivered only to 11 the premises listed on the license, except that the manufacturer 12 or wholesale distributor may furnish prescription drugs to an 13 authorized person or agent of that person at the premises of the 14 manufacturer or wholesale distributor if: 15 (1) The identity and authorization of the recipient is 16 properly established. 17 (2) This method of receipt is employed only to meet the 18 immediate needs of a particular patient of the authorized 19 person. 20 (d) Hospital pharmacy.--Prescription drugs may be furnished 21 to a hospital pharmacy receiving area, except that a pharmacist 22 or authorized receiving personnel shall sign, at the time of 23 delivery, a receipt showing the type and quantity of the 24 prescription drug so received. Any discrepancy between the 25 receipt and the type and quantity of the prescription drug 26 actually received shall be reported to the delivering 27 manufacturer or wholesale distributor by the next business day 28 after the delivery to the pharmacy receiving area. 29 (e) Credit.--A manufacturer or wholesale distributor shall 30 not accept payment for or allow the use of a person's or 20070S0311B0427 - 13 -
1 entity's credit to establish an account for the purchase of 2 prescription drugs from any person other than the owner of 3 record, the chief executive officer or the chief financial 4 officer listed on the license of a person or entity legally 5 authorized to receive prescription drugs. Any account 6 established for the purchase of prescription drugs shall bear 7 the name of the licensee. 8 Section 5. Pedigree. 9 (a) General rule.--Each person, including repackagers but 10 excluding the original manufacturer of the finished form of the 11 prescription drug, who is engaged in wholesale distribution of 12 prescription drugs that leave or have ever left the normal 13 distribution channel shall, before each wholesale distribution 14 of such drug, provide a pedigree to the person who receives such 15 drug. The following shall apply: 16 (1) A retail pharmacy or chain pharmacy warehouse shall 17 comply with the requirements of this section only if the 18 pharmacy or chain pharmacy warehouse engages in wholesale 19 distribution of prescription drugs. 20 (2) The State licensing authority shall conduct a study 21 to be completed within one year after the effective date of 22 this section. The report shall include consultation with 23 manufacturers, distributors and pharmacies responsible for 24 the sale and distribution of prescription drug products in 25 this Commonwealth. Based on the results of the study the 26 State licensing authority shall determine a mandated 27 implementation date for electronic pedigrees. The 28 implementation date for the mandated electronic pedigree 29 shall be no sooner than December 31, 2010, and may be 30 extended by the State Board of Pharmacy in one year 20070S0311B0427 - 14 -
1 increments if it appears the technology is not universally 2 available across the entire prescription pharmaceutical 3 supply chain. 4 (b) Authentication.--Each person who is engaged in the 5 wholesale distribution of a prescription drug, including 6 repackagers, but excluding the original manufacturer of the 7 finished form of the prescription drug, and who is in possession 8 of a pedigree for a prescription drug and attempts to further 9 distribute that prescription drug shall affirmatively verify 10 before any distribution of a prescription drug occurs that each 11 transaction listed on the pedigree has occurred. 12 (c) Contents.--The pedigree shall: 13 (1) Include all necessary identifying information 14 concerning each sale in the chain of distribution of the 15 product from the manufacturer or from the manufacturer's 16 third-party logistics provider, colicensed product partner or 17 exclusive distributor through acquisition and sale by any 18 wholesale distributor or repackager until final sale, to a 19 pharmacy or other person dispensing or administering the 20 drug. At minimum, the necessary chain of distribution 21 information shall include: 22 (i) Name, address, telephone number and, if 23 available, the e-mail address of each owner of the 24 prescription drug and each wholesale distributor of the 25 prescription drug. 26 (ii) Name and address of each location from which 27 the product was shipped, if different from the owner's. 28 (iii) Transaction dates. 29 (iv) Certification that each recipient has 30 authenticated the pedigree. 20070S0311B0427 - 15 -
1 (2) At minimum, the: 2 (i) Name of the prescription drug. 3 (ii) Dosage form and strength of the prescription 4 drug. 5 (iii) Size of the container. 6 (iv) Number of containers. 7 (v) Lot number of the prescription drug. 8 (vi) Name of the manufacturer of the finished dosage 9 form. 10 (d) Maintenance provisions.--Each pedigree or electronic 11 file shall be: 12 (1) Maintained by the purchaser and the wholesale 13 distributor for three years from the date of sale or 14 transfer. 15 (2) Available for inspection or use upon a request of an 16 authorized officer of the law. 17 (e) Implementation.--The State licensing authority shall 18 adopt rules, regulations and a form relating to the requirements 19 of this section no later than 90 days after the effective date 20 of this section. 21 Section 6. Enforcement; order to cease distribution of drug. 22 (a) Order to cease distribution of a prescription drug.--The 23 State licensing authority shall issue an order requiring the 24 appropriate person, including manufacturers, distributors or 25 retailers of a drug, to immediately cease distribution of the 26 drug if there is a reasonable probability that: 27 (1) A wholesale distributor other than a manufacturer 28 has: 29 (i) violated a provision of this act; or 30 (ii) falsified a pedigree or sold, distributed, 20070S0311B0427 - 16 -
1 transferred, manufactured, repackaged, handled or held a 2 counterfeit prescription drug intended for human use. 3 (2) The prescription drug at issue in paragraph (1) 4 could cause serious, adverse health consequences or death. 5 (3) Other procedures would result in unreasonable delay. 6 (b) Informal hearing.--An order under subsection (a) shall 7 provide the person subject to the order with an opportunity for 8 an informal hearing, to be held not later than ten days after 9 the date of the issuance of the order. If after providing an 10 opportunity for such a hearing the State licensing authority 11 determines that inadequate grounds exist to support the actions 12 required by the order, the order shall be vacated. 13 Section 7. Prohibited acts. 14 (a) General rule.--It is unlawful for a person to perform or 15 cause the performance of or aid and abet any of the following 16 acts in this Commonwealth: 17 (1) Failure to obtain a license in accordance with this 18 act or operating without a valid license when a license is 19 required by this act. 20 (2) Purchasing or otherwise receiving a prescription 21 drug from a pharmacy, unless the requirements of this act are 22 met. 23 (3) Sale, distribution or transfer of a prescription 24 drug to a person that is not authorized under the law of the 25 jurisdiction in which the person receives the prescription 26 drug to receive the prescription drug in violation of this 27 act. 28 (4) Failure to deliver prescription drugs to specified 29 premises as required by this act. 30 (5) Accepting payment or credit for the sale of 20070S0311B0427 - 17 -
1 prescription drugs in violation of this act. 2 (6) Failure to maintain or provide pedigrees as required 3 by this act. 4 (7) Failure to obtain, pass or authenticate a pedigree 5 as required by this act. 6 (8) Providing the State licensing authority or any of 7 its representatives or any Federal official with false or 8 fraudulent records or making false or fraudulent statements 9 regarding any matter within the provisions of this act. 10 (9) Obtaining or attempting to obtain a prescription 11 drug by fraud, deceit, misrepresentation or engaging in 12 misrepresentation or fraud in the distribution of a 13 prescription drug. 14 (10) Except for the wholesale distribution by 15 manufacturers of a prescription drug that has been delivered 16 into commerce pursuant to an application approved by the FDA, 17 the manufacture, repackaging, sale, transfer, delivery, 18 holding or offering for sale any prescription drug that is 19 adulterated, misbranded, counterfeit, suspected of being 20 counterfeit or has otherwise been rendered unfit for 21 distribution. 22 (11) Except for the wholesale distribution by 23 manufacturers of a prescription drug that has been delivered 24 into commerce pursuant to an application approved by the FDA, 25 the adulteration, misbranding or counterfeiting of any 26 prescription drug. 27 (12) The receipt of any prescription drug that is 28 adulterated, misbranded, stolen, obtained by fraud or deceit, 29 counterfeit or suspected of being counterfeit, and the 30 delivery or proffered delivery of such drug for pay or 20070S0311B0427 - 18 -
1 otherwise. 2 (13) The alteration, mutilation, destruction, 3 obliteration or removal of the whole or any part of the 4 labeling of a prescription drug or the commission of any 5 other act with respect to a prescription drug that results in 6 the prescription drug being misbranded. 7 (b) Testing.--Subsection (a) does not apply to a 8 prescription drug manufacturer, or agent of a prescription drug 9 manufacturer, obtaining or attempting to obtain a prescription 10 drug for the sole purpose of testing the prescription drug for 11 authenticity. 12 Section 8. Penalties. 13 (a) General violations.--A person who engages in the 14 wholesale distribution of prescription drugs in violation of 15 this act commits a felony of the second degree and shall, upon 16 conviction, be sentenced to pay a fine of not more than $50,000 17 or to imprisonment for not more than ten years, or both. 18 (b) Knowing violations.--A person who knowingly engages in 19 wholesale distribution of prescription drugs in violation of 20 this act commits a felony of the first degree and shall, upon 21 conviction, be sentenced to pay a fine of not more than $500,000 22 or to imprisonment for not more than 20 years, or both. 23 Section 9. Effective date. 24 This act shall take effect immediately. B6L35RLE/20070S0311B0427 - 19 -