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
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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
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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)).
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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
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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.
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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
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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
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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
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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
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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
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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.
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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
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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
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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.
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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,
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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
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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
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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.
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