CHAPTER 14. WHOLESALE LEGEND DRUG DISTRIBUTORS
IC 25-26-14
Chapter 14. Wholesale Legend Drug Distributors
IC 25-26-14-1
Application of chapter
Sec. 1. (a) This chapter applies to any individual, partnership,limited liability company, corporation, or business firm:
(1) located in or outside Indiana; and
(2) engaging in the wholesale distribution of legend drugs inIndiana.
(b) Except as required by federal law or regulation, therequirements of this chapter do not apply to a manufacturer that isapproved by the federal Food and Drug Administration. However,the board may adopt rules concerning manufacturers that the boardconsiders appropriate and necessary.
(c) The requirements of this chapter do not apply to a medical gasmanufacturer or distributor that only manufactures or distributesmedical gases.
As added by P.L.182-1991, SEC.3. Amended by P.L.8-1993,SEC.394; P.L.212-2005, SEC.23; P.L.98-2006, SEC.12.
IC 25-26-14-1.5
"Adulterated" defined
Sec. 1.5. As used in this chapter, "adulterated" refers to a legenddrug that:
(1) consists in whole or in part of a filthy, putrid, ordecomposed substance;
(2) has been produced, prepared, packed, or held underunsanitary conditions and may have been contaminated orrendered injurious to health;
(3) has been subjected to conditions in the manufacture,processing, packing, or holding of the legend drug that do notconform to current standards of manufacturing to ensure thatthe legend drug is safe for use and possesses the identity,strength, quality, and purity characteristics that the legend drugis represented to possess;
(4) is contained in a container composed of a poisonous ordeleterious substance that may render the legend drug injuriousto health;
(5) bears or contains, for purposes of coloring only, a coloradditive that is unsafe;
(6) is of a different strength, quality, or purity from the officialcompendium standard for the legend drug; or
(7) does not meet the considerations of the federal Food, Drug,and Cosmetic Act.
As added by P.L.212-2005, SEC.24.
IC 25-26-14-1.7
"Authenticate" defined
Sec. 1.7. As used in this chapter, "authenticate" means to
affirmatively verify before distribution occurs that each transactionthat is listed on:
(1) the pedigree of a legend drug; and
(2) other accompanying documentation for a legend drug;
has occurred.
As added by P.L.212-2005, SEC.25.
IC 25-26-14-1.8
"Authorized distributor" defined
Sec. 1.8. As used in this chapter, "authorized distributor" meansa wholesale drug distributor with which a manufacturer hasestablished an ongoing relationship to distribute the manufacturer'sproducts. For purposes of this section, an ongoing relationship existsbetween a wholesale drug distributor, including any affiliated group(as defined in Section 1504 of the Internal Revenue Code) of whichthe wholesale distributor is a member, and a manufacturer if thewholesale drug distributor:
(1) has a written agreement currently in effect with themanufacturer evidencing an ongoing relationship;
(2) is listed on the manufacturer's current monthly updated listof authorized distributors; or
(3) has a verifiable account with the manufacturer and aminimal transaction or volume requirement limit of:
(A) five thousand (5,000) units per company in the previoustwelve (12) months; or
(B) twelve (12) purchases at the manufacturer's minimumpurchasing requirement per invoice in the previous twelve(12) months.
As added by P.L.212-2005, SEC.26.
IC 25-26-14-2
"Blood" defined
Sec. 2. As used in this chapter, "blood" means whole bloodcollected from a single donor and processed either for transfusion orfurther manufacturing.
As added by P.L.182-1991, SEC.3.
IC 25-26-14-3
"Blood component" defined
Sec. 3. As used in this chapter, "blood component" means thatpart of blood separated by physical or mechanical means.
As added by P.L.182-1991, SEC.3.
IC 25-26-14-3.7
"Chain drug warehouse" defined
Sec. 3.7. As used in this chapter, "chain drug warehouse" meansa permanent physical location for drugs or devices, or both, that:
(1) is licensed as a wholesale distributor;
(2) acts as a central warehouse; and
(3) primarily performs intracompany sales and transfers of
legend drugs or devices to members of the same affiliated groupthat is under common ownership and control.
As added by P.L.98-2006, SEC.13.
IC 25-26-14-4
"Board" defined
Sec. 4. As used in this chapter, "board" refers to the Indiana boardof pharmacy established under IC 25-26-13-3.
As added by P.L.182-1991, SEC.3.
IC 25-26-14-4.1
"Co-licensed products" defined
Sec. 4.1. As used in this chapter, "co-licensed products" meanspharmaceutical products:
(1) that have been approved by the federal Food and DrugAdministration; and
(2) concerning which two (2) or more parties have the right toengage in a business activity or occupation concerning thepharmaceutical products.
As added by P.L.212-2005, SEC.27.
IC 25-26-14-4.2
"Compendium" defined
Sec. 4.2. As used in this chapter, "compendium" refers to:
(1) the United States Pharmacopoeia;
(2) the Homeopathic Pharmacopoeia of the United States;
(3) the National Formulary;
(4) a drug approved by the federal Food and DrugAdministration; or
(5) a supplement to a document specified in subdivision (1), (2),or (3).
As added by P.L.212-2005, SEC.28.
IC 25-26-14-4.3
"Contraband" defined
Sec. 4.3. As used in this chapter, "contraband" refers to a legenddrug:
(1) that is counterfeit;
(2) that is stolen;
(3) that is misbranded;
(4) that is obtained by fraud;
(5) that is purchased by a nonprofit institution for the nonprofitinstitution's own use and placed in commerce in violation of theown use agreement for the legend drug;
(6) for which a required pedigree does not exist; or
(7) for which a pedigree in existence:
(A) has been forged, counterfeited, or falsely created; or
(B) contains any altered, false, or misrepresentedinformation.
As added by P.L.212-2005, SEC.29.
IC 25-26-14-4.4
"Counterfeit" defined
Sec. 4.4. As used in this chapter, "counterfeit" refers to a legenddrug, or the container, seal, or labeling of a legend drug, that, withoutauthorization, bears the trademark, trade name, or other identifyingmark or imprint of a manufacturer, processor, packer, or distributorother than the person that manufactured, processed, packed, ordistributed the legend drug.
As added by P.L.212-2005, SEC.30.
IC 25-26-14-4.5
"Deliver" defined
Sec. 4.5. As used in this chapter, "deliver" means the actual,constructive, or attempted transfer of a legend drug from one (1)person to another.
As added by P.L.212-2005, SEC.31.
IC 25-26-14-4.6
"Designated representative" defined
Sec. 4.6. As used in this chapter, "designated representative"means an individual who:
(1) is designated by a wholesale drug distributor;
(2) serves as the wholesale drug distributor's responsibleindividual with the board; and
(3) is actively involved in and aware of the actual dailyoperation of the wholesale drug distributor.
As added by P.L.212-2005, SEC.32.
IC 25-26-14-4.7
"Distribute" defined
Sec. 4.7. As used in this chapter, "distribute" means to sell, offerto sell, deliver, offer to deliver, broker, give away, or transfer alegend drug, whether by passage of title or physical movement, orboth. The term does not include the following:
(1) Dispensing or administering a legend drug.
(2) Delivering or offering to deliver a legend drug by a commoncarrier in the usual course of business as a common carrier.
(3) The provision of a legend drug sample to a patient by a:
(A) practitioner;
(B) health care professional acting at the direction and underthe supervision of a practitioner; or
(C) hospital's or other health care entity's pharmacy thatreceived the drug sample in accordance with this chapter andother applicable law to administer or dispense and that isacting at the direction of a practitioner;
licensed to prescribe the legend drug.
As added by P.L.212-2005, SEC.33.
IC 25-26-14-5
"Drug sample" defined Sec. 5. As used in this chapter, "drug sample" means a unit of alegend drug that is not intended to be sold and is intended to promotethe sale of the drug.
As added by P.L.182-1991, SEC.3.
IC 25-26-14-6
"Health care entity" defined
Sec. 6. As used in this chapter, "health care entity" means anyorganization or business that provides diagnostic, medical, surgical,dental treatment, or rehabilitative care. The term does not include apharmacy or wholesale drug distributor.
As added by P.L.182-1991, SEC.3. Amended by P.L.212-2005,SEC.34.
IC 25-26-14-6.5
"Label" defined
Sec. 6.5. As used in this chapter, "label" means a display ofwritten, printed, or graphic matter on the immediate container of alegend drug.
As added by P.L.212-2005, SEC.35.
IC 25-26-14-6.6
"Labeling" defined
Sec. 6.6. As used in this chapter, "labeling" means labels andother written, printed, or graphic matter:
(1) on a legend drug or a legend drug's container or wrapper; or
(2) accompanying a legend drug.
As added by P.L.212-2005, SEC.36.
IC 25-26-14-7
"Legend drug" defined
Sec. 7. As used in this chapter, "legend drug" has the meaning setforth in IC 16-18-2-199. The term includes any human drug requiredby federal law or regulation to be dispensed only by a prescription,including finished dosage forms and active ingredients subject to 21U.S.C. 811 through 812. The term does not include a device or adevice component, part, or accessory.
As added by P.L.182-1991, SEC.3. Amended by P.L.2-1993,SEC.147; P.L.212-2005, SEC.37.
IC 25-26-14-8
"Manufacturer" defined
Sec. 8. As used in this chapter, "manufacturer" means a personwho is engaged in manufacturing, preparing, propagating,compounding, processing, packaging, repackaging, or labeling of alegend drug.
As added by P.L.182-1991, SEC.3.
IC 25-26-14-8.3
"Misbranded" defined Sec. 8.3. As used in this chapter, "misbranded" means that alegend drug's label:
(1) is false or misleading;
(2) does not bear the name and address of the manufacturer,packer, or distributor or does not contain an accurate statementof the quantities of active ingredients of the legend drug;
(3) does not show an accurate monograph for the legend drug;or
(4) does not comply with any other requirements of the federalFood, Drug, and Cosmetic Act.
As added by P.L.212-2005, SEC.38.
IC 25-26-14-8.5
"Normal distribution chain of custody" defined
Sec. 8.5. As used in this chapter, "normal distribution chain ofcustody" means the route that a legend drug travels:
(1) from a manufacturer to a wholesale drug distributor, to apharmacy, and to a patient or a patient's agent;
(2) from a manufacturer to a wholesale drug distributor, to achain drug warehouse, to a pharmacy affiliated with the chaindrug warehouse, and to a patient or a patient's agent;
(3) from a manufacturer to a chain drug warehouse, to apharmacy affiliated with the chain drug warehouse, and to apatient or a patient's agent;
(4) from a manufacturer to a third party logistics provider, to awholesale drug distributor, to a pharmacy, and to a patient or apatient's agent;
(5) from a manufacturer to a third party logistics provider, to awholesale drug distributor, to a chain drug warehouse, to apharmacy affiliated with the chain drug warehouse, and to apatient or a patient's agent;
(6) from a manufacturer to a third party logistics provider, to achain drug warehouse, to a pharmacy affiliated with the chaindrug warehouse, and to a patient or a patient's agent; or
(7) as prescribed by rules adopted by the board.
As added by P.L.212-2005, SEC.39.
IC 25-26-14-8.7
"Pedigree" defined
Sec. 8.7. As used in this chapter, "pedigree" means a statement orrecord in a written or an electronic form that is approved by theboard, that:
(1) records each wholesale distribution of a legend drug fromthe sale by the manufacturer that leaves the normal distributionchain of custody and that includes information designated bythe board through rules for each transaction; or
(2) complies with a legend drug pedigree law or regulation inanother state or United States territory that meets the pedigreerequirements under this chapter.
As added by P.L.212-2005, SEC.40. Amended by P.L.98-2006,
SEC.14.
IC 25-26-14-9
"Person" defined
Sec. 9. As used in this chapter, "person" means an individual, apartnership, a business firm, a limited liability company, acorporation, or another entity, including a governmental entity.
As added by P.L.182-1991, SEC.3. Amended by P.L.8-1993,SEC.395; P.L.212-2005, SEC.41.
IC 25-26-14-9.2
"Practitioner" defined
Sec. 9.2. As used in this chapter, "practitioner" has the meaningset forth in IC 16-42-19-5.
As added by P.L.212-2005, SEC.42.
IC 25-26-14-9.3
"Repackage" defined
Sec. 9.3. As used in this chapter, "repackage" means changing thecontainer, wrapper, quantity, or labeling of a legend drug to furtherthe distribution of the legend drug.
As added by P.L.212-2005, SEC.43.
IC 25-26-14-10
"Sale" defined
Sec. 10. As used in this chapter, "sale" includes purchase, trade,or offer to sell, purchase, or trade.
As added by P.L.182-1991, SEC.3.
IC 25-26-14-10.5
"Third party logistics provider" defined
Sec. 10.5. As used in this chapter, "third party logistics provider"means an entity that:
(1) provides or coordinates warehousing, distribution, or otherservices on behalf of a manufacturer, but does not take title tothe legend drug or have general responsibility to direct thelegend drug's sale or disposition; and
(2) is licensed under this chapter.
As added by P.L.212-2005, SEC.44.
IC 25-26-14-11
"Wholesale distribution" defined
Sec. 11. As used in this chapter, "wholesale distribution" meansto distribute legend drugs to persons other than a consumer orpatient. The term does not include:
(1) a sale or transfer between a division, a subsidiary, a parent,an affiliated, or a related company under the commonownership and control of a corporate entity;
(2) the purchase or acquisition by a hospital or other health careentity that is a member of a group purchasing organization of a
drug for the hospital's or health care entity's own use from thegroup purchasing organization or from other hospitals or healthcare entities that are members of the organization;
(3) the sale of a drug by a charitable organization described inSection 501(c)(3) of the Internal Revenue Code, to a nonprofitaffiliate of the organization to the extent otherwise permitted bylaw;
(4) the sale of a drug among hospitals or other health careentities that are under common control;
(5) the sale of a drug for emergency medical reasons, includingtransfers of legend drugs by a retail pharmacy to another retailpharmacy to alleviate a temporary shortage, if the gross dollarvalue of the transfers does not exceed five percent (5%) of thetotal legend drug sales revenue of either the transferor ortransferee pharmacy during any twelve (12) consecutive monthperiod;
(6) the sale of a drug or the dispensing of a drug pursuant to aprescription;
(7) the distribution of drug samples by manufacturers'representatives or distributors' representatives;
(8) the sale of blood and blood components intended fortransfusion;
(9) the sale of a drug by a retail pharmacy to a practitioner (asdefined in IC 25-26-13-2) for office use, if the gross dollarvalue of the transfers does not exceed five percent (5%) of theretail pharmacy's total legend drug sales during any twelve (12)consecutive months;
(10) the sale of a drug by a retail pharmacy that is ending itsbusiness and liquidating its inventory to another retailpharmacy;
(11) drug returns by a hospital, health care entity, or charitableinstitution conducted under 21 CFR 203.23;
(12) the sale of minimal quantities of drugs by retail pharmaciesto licensed practitioners for office use;
(13) the distribution of prescription drugs by the originalmanufacturer of the finished form of the prescription drug orthe distribution of the co-licensed products by a partner of theoriginal manufacturer of the finished form of the prescriptiondrug; or
(14) drug returns that meet criteria established by rules adoptedby the board.
As added by P.L.182-1991, SEC.3. Amended by P.L.33-1993,SEC.47; P.L.212-2005, SEC.45.
IC 25-26-14-12
"Wholesale drug distributor" defined
Sec. 12. As used in this chapter, "wholesale drug distributor"means a person engaged in wholesale distribution of legend drugs,including:
(1) manufacturers; (2) repackers;
(3) own-label distributors;
(4) private-label distributors;
(5) jobbers;
(6) brokers;
(7) warehouses, including manufacturers' and distributors'warehouses, chain drug warehouses, and wholesale drugwarehouses;
(8) independent wholesale drug traders;
(9) retail and hospital pharmacies that conduct wholesaledistributions; and
(10) reverse distributors.
The term does not include a common carrier or person hired solelyto transport prescription drugs.
As added by P.L.182-1991, SEC.3. Amended by P.L.98-2006,SEC.15.
IC 25-26-14-13
Rules
Sec. 13. The board shall adopt rules under IC 4-22-2 that conformwith wholesale drug distributor licensing guidelines adopted by theUnited States Food and Drug Administration (21 CFR 205),including rules:
(1) necessary to carry out the purposes of this chapter;
(2) that incorporate and set detailed standards for meeting eachof the license prerequisites set forth in this chapter; and
(3) establishing reasonable fees to carry out this chapter.
As added by P.L.182-1991, SEC.3.
IC 25-26-14-14
Accreditation and license for wholesale distribution of legenddrugs
Sec. 14. (a) A person may not engage in wholesale distributionsof legend drugs without:
(1) after December 31, 2005, obtaining and maintainingaccreditation or certification from the National Association ofBoards of Pharmacy's Verified Accredited WholesaleDistributor or an accreditation body approved by the boardunder subsection (g);
(2) obtaining and maintaining a license issued by the board; and
(3) paying any reasonable fee required by the board.
(b) The board may not issue or renew the license of a wholesaledrug distributor that does not comply with this chapter.
(c) The board shall require a separate license for each facility orlocation where wholesale distribution operations are conducted.
(d) An agent or employee of any licensed wholesale drugdistributor does not need a license and may lawfully possesspharmaceutical drugs when acting in the usual course of business oremployment.
(e) The issuance of a license under this chapter does not affect tax
liability imposed by the department of state revenue or thedepartment of local government finance on any wholesale drugdistributor.
(f) The board may adopt rules that permit out-of-state wholesaledrug distributors to obtain a license on the basis of reciprocity if:
(1) an out-of-state wholesale drug distributor possesses a validlicense granted by another state and the legal standards forlicensure in the other state are comparable to the standardsunder this chapter; and
(2) the other state extends reciprocity to wholesale drugdistributors licensed in Indiana.
However, if the requirements for licensure under this chapter aremore restrictive than the standards of the other state, the out-of-statewholesale drug distributor must comply with the additionalrequirements of this chapter to obtain a license under this chapter.
(g) The board may adopt rules under IC 4-22-2 to approve anaccreditation body to:
(1) evaluate a wholesale drug distributor's operations todetermine compliance with:
(A) professional standards;
(B) this chapter; and
(C) any other applicable law; and
(2) perform inspections of each facility and location wherewholesale distribution operations are conducted by thewholesale drug distributor.
As added by P.L.182-1991, SEC.3. Amended by P.L.90-2002,SEC.456; P.L.212-2005, SEC.46.
IC 25-26-14-14.5
Pedigree required
Sec. 14.5. After June 30, 2006, a wholesale drug distributor maynot accept or deliver a legend drug without a current, accompanyingpedigree as required under section 17 of this chapter.
As added by P.L.212-2005, SEC.47. Amended by P.L.98-2006,SEC.16.
IC 25-26-14-15
Information for grant and renewal of license; surety bond;inspection; reporting change in information
Sec. 15. (a) The board shall require the following minimuminformation from each wholesale drug distributor as part of thelicense described in section 14 of this chapter and as part of anyrenewal of such license:
(1) The name, full business address, and telephone number ofthe licensee.
(2) All trade or business names used by the licensee.
(3) Addresses, telephone numbers, and the names of contactpersons for all facilities used by the licensee for the storage,handling, and distribution of legend drugs.
(4) The type of ownership of operation. (5) The name of each owner and operator of the licensee,including:
(A) if an individual, the name, address, Social Securitynumber, and date of birth of the individual;
(B) if a partnership, the name, address, Social Securitynumber, and date of birth of each partner, and the name ofthe partnership and federal employer identification number;
(C) if a corporation:
(i) the name, address, Social Security number, date ofbirth, and title of each corporate officer and director;
(ii) the corporate names, the name of the state ofincorporation, the federal employer identification number,and the name of the parent company, if any; and
(iii) the name, address, and Social Security number of eachshareholder owning ten percent (10%) or more of thevoting stock of the corporation, unless the stock is tradedon a major stock exchange and not traded over the counter;
(D) if a limited liability company, the name of each managerand member, the name and federal employer identificationnumber of the limited liability company, and the name of thestate where organized; and
(E) if a sole proprietorship, the full name, address, SocialSecurity number, and date of birth of the sole proprietor andthe name and federal employer identification number of thebusiness entity.
(6) The name, address, and telephone number of the designatedrepresentative of each facility.
(7) Additional information concerning record keeping requiredunder this chapter.
(b) The board shall require a wholesale drug distributor to post asurety bond of at least one hundred thousand dollars ($100,000), oran equivalent means of security acceptable to the board, includinginsurance, an irrevocable letter of credit, or funds deposited in a trustaccount or financial institution, to secure payment of anyadministrative penalties that may be imposed by the board and anyfees and costs that may be incurred by the board and that:
(1) are related to a license held by the wholesale drugdistributor;
(2) are authorized under Indiana law; and
(3) the wholesale drug distributor fails to pay less than thirty(30) days after the penalties, fees, or costs become final.
However, a separate surety bond or an equivalent means of securityis not required for a separate location or a company of the wholesaledrug distributor.
(c) The board may make a claim against a bond or security postedunder subsection (b) within one (1) year after the wholesale drugdistributor's license is no longer valid or sixty (60) days after theconclusion of:
(1) an administrative or legal proceeding before or on behalf ofthe board that involves the wholesale drug distributor and
results in penalties, fees, or costs described in subsection (b); or
(2) an appeal of a proceeding described in subdivision (1);
whichever occurs later.
(d) The board or the board's designee shall inspect each facilitywhere wholesale distribution operations are conducted before initiallicensure and periodically thereafter in accordance with a scheduledetermined by the board, but at least one (1) time in each three (3)year period.
(e) A wholesale drug distributor must publicly display or havereadily available all licenses and the most recent inspection reportadministered by the board or the board's designee.
(f) A material change in any information in this section must besubmitted to the board at the time of license renewal or within thirty(30) days from the date of the change, whichever occurs first.
As added by P.L.182-1991, SEC.3. Amended by P.L.8-1993,SEC.396; P.L.212-2005, SEC.48; P.L.98-2006, SEC.17.
IC 25-26-14-15.5
Repealed
(Repealed by P.L.98-2006, SEC.29.)
IC 25-26-14-16
Distributor qualifications; criminal history and financialbackground check
Sec. 16. (a) In reviewing, for purposes of licensure or renewal ofa license under this chapter, the qualifications of persons who engagein wholesale distribution of legend drugs in Indiana, the board shallconsider the following factors:
(1) A finding by the board that the applicant has:
(A) violated a law; or
(B) been disciplined by a regulatory agency for violating alaw;
related to drug distribution in any state.
(2) A criminal conviction of the applicant.
(3) The applicant's past experience in the manufacture ordistribution of legend drugs, including controlled substances.
(4) The furnishing by the applicant of false or fraudulentmaterial in any application made in connection with drugmanufacturing or distribution.
(5) Suspension or revocation of any license held by theapplicant or the applicant's owner or the imposition of sanctionsagainst the applicant or the applicant's owner by the federal ora state or local government for the manufacture or distributionof any drugs, including controlled substances.
(6) Compliance with licensing requirements under previouslygranted licenses.
(7) Compliance with requirements to maintain and makeavailable to the board or to federal, state, or local lawenforcement officials those records required under this chapter.
(8) Any other factors or qualifications the board considers
relevant to the public health and safety, including whether thegranting of the license would not be in the public interest.
(b) In reviewing an application for licensure or renewal of alicense under this chapter, the board shall consider the results ofcriminal history and financial background checks for:
(1) the designated representative or the most senior individualresponsible for facility operations, purchasing, and inventorycontrol;
(2) the supervisor or the designated representative or the mostsenior individual under subdivision (1); and
(3) principals and owners with more than a ten percent (10%)interest in the wholesale drug distributor, if the wholesale drugdistributor is a nonpublicly held company.
(c) The criminal history and financial background checksconducted under subsection (b) must:
(1) be conducted at the applicant's expense;
(2) include a criminal history for all current and previous statesof residence of the applicant;
(3) include the criminal history in the federal district where theapplicant currently resides;
(4) include information from the previous seven (7) years; and
(5) be approved by the board.
(d) An applicant shall provide and attest to:
(1) an affirmation that the applicant has not been involved in orconvicted of any criminal or prohibited acts; or
(2) a statement providing a complete disclosure of theapplicant's past criminal convictions and violations of state andfederal laws;
regarding drugs.
As added by P.L.182-1991, SEC.3. Amended by P.L.212-2005,SEC.50; P.L.98-2006, SEC.18.
IC 25-26-14-16.5
Designated representative; application; experience requirement;continuing education
Sec. 16.5. (a) A wholesale drug distributor shall designate inwriting on a form prescribed by the board a designated representativefor each of the wholesale drug distributor's facilities licensed underthis chapter.
(b) A designated representative shall submit to the board anapplication prescribed by the board and provide to the board thefollowing:
(1) The date and place of birth of the designated representative.
(2) A list of the occupations, positions of employment, andoffices held by the designated representative during theimmediately preceding seven (7) years, including the principalbusiness and address of the organization with which theoccupation, position, or office was associated.
(3) A statement concerning whether the designatedrepresentative, during the immediately preceding seven (7)
years, has been temporarily or permanently enjoined by a courtfrom violating a state or federal law regulating the possession,control, or distribution of legend drugs, including details ofrelated events.
(4) A description of any involvement by the designatedrepresentative with a business that:
(A) manufactured, administered, prescribed, distributed, orstored legend drugs; and
(B) was named as a party in a lawsuit;
during the immediately preceding seven (7) years, includinginvestments other than the ownership of stock in a publiclytraded company or mutual fund.
(5) A description of any criminal offense of which thedesignated representative has been convicted, regardless ofwhether adjudication of guilt was withheld or whether thedesignated representative pleaded nolo contendere. If thedesignated representative indicates that a criminal conviction isunder appeal, the designated representative shall submit to theboard:
(A) a copy of the notice of appeal; and
(B) a copy of the final written order of disposition.
(6) A photograph of the designated representative taken withinthe immediately preceding thirty (30) days under proceduresspecified by the board.
(7) A list of the name, address, occupation, and date and placeof birth of each member of the designated representative'simmediate family, including the designated representative'sspouse, children, parents, and siblings, and the spouses of thedesignated representative's children and siblings. Informationcollected under this subdivision is confidential.
(8) Any other information required by the board.
(c) A designated representative must have at least two (2) yearsof verifiable full-time managerial or supervisory experience in apharmacy or with a wholesale drug distributor licensed under thischapter or in another state. The designated representative'sresponsibilities must have included record keeping, storage, andshipment of legend drugs.
(d) A designated representative shall not serve as the designatedrepresentative for more than one (1) wholesale drug distributorfacility at any one (1) time.
(e) A designated representative shall be actively involved andaware of the actual daily operations of the wholesale drug distributoras follows:
(1) Be employed full time in a managerial position by thewholesale drug distributor.
(2) Be physically present at the wholesale drug distributor'sfacility during normal business hours, except when absent dueto illness, family illness or death, scheduled vacation, or anotherauthorized absence.
(3) Be aware of and knowledgeable about all policies and
procedures pertaining to the operations of the wholesale drugdistributor.
(f) A designated representative must complete continuingeducation programs specified by the board regarding state andfederal law relevant to the distribution, handling, and storage oflegend drugs.
(g) A third party logistics provider must comply with thissubsection until the third party logistics provider has obtainedaccreditation. A third party logistics provider must identify to theboard a designated representative who is responsible for the facility'scompliance with applicable state and federal law. The designatedrepresentative:
(1) may be a corporate employee or officer, outside counsel, oran outside consulting specialist with authority to help ensurecompliance;
(2) may be responsible for multiple facilities; and
(3) is not required to be physically present at the facility.
As added by P.L.212-2005, SEC.51. Amended by P.L.98-2006,SEC.19.
IC 25-26-14-16.6
Designated agent; service of process
Sec. 16.6. (a) A wholesale drug distributor that:
(1) is licensed under this chapter;
(2) is located outside Indiana; and
(3) distributes legend drugs in Indiana;
shall designate an agent in Indiana for service of process.
(b) A wholesale drug distributor that does not designate an agentunder subsection (a) is considered to have designated the secretaryof state to be the wholesale drug distributor's true and lawfulattorney, upon whom legal process may be served in an action or aproceeding against the wholesale drug distributor arising from thewholesale drug distributor's wholesale distribution operations.
(c) The board shall mail a copy of any service of process to awholesale drug distributor by certified mail, return receipt requested,postage prepaid, at the address designated by the wholesale drugdistributor on the application for licensure submitted under thischapter.
(d) Service of process on the secretary of state is sufficient in anaction or a proceeding against a wholesale drug distributor that is notlicensed under this chapter.
As added by P.L.212-2005, SEC.52.
IC 25-26-14-17
Applicant assurances as condition of license
Sec. 17. As a condition for receiving and retaining a wholesaledrug distributor license issued under this chapter, an applicant mustsatisfy the board that the applicant has and will continuouslymaintain the following:
(1) Acceptable storage and handling conditions and facilities
standards for each facility at which legend drugs are received,stored, warehoused, handled, held, offered, marketed, ordisplayed, or from which legend drugs are transported,including:
(A) suitable construction of the facility and appropriatemonitoring equipment to ensure that legend drugs in thefacility are maintained in accordance with labeling or incompliance with official compendium standards;
(B) suitable size and construction to facilitate cleaning,maintenance, and proper wholesale distribution operations;
(C) adequate storage areas to provide appropriate lighting,ventilation, temperature, sanitation, humidity, space,equipment, and security conditions;
(D) a quarantine area for separate storage of legend drugsthat are outdated, damaged, deteriorated, misbranded,adulterated, counterfeit, suspected counterfeit, otherwiseunfit for distribution, or contained in immediate or sealedsecondary containers that have been opened;
(E) maintenance of the facility in a clean and orderlycondition;
(F) maintenance of the facility in a commercial,nonresidential building; and
(G) freedom of the facility from infestation.
(2) Security of each facility from unauthorized entry as follows:
(A) Entry into areas where legend drugs are held is limitedto authorized personnel.
(B) Each facility is equipped with a security system thatincludes:
(i) an after hours central alarm or a comparable entrydetection capability;
(ii) restricted premises access;
(iii) adequate outside perimeter lighting;
(iv) safeguards against theft and diversion, includingemployee theft and theft or diversion facilitated or hiddenby tampering with computers or electronic records; and
(v) a means of protecting the integrity and confidentialityof data and documents and of making the data anddocuments readily available to the board and other stateand federal law enforcement officials.
(3) A reasonable system of record keeping as follows:
(A) The system describes all the wholesale distributor'sactivities governed by this chapter for the three (3) yearperiod after the disposition of each product, and all recordsare maintained for at least three (3) years after disposition ofthe legend drug to which the record applies.
(B) The system is reasonably accessible as determined byboard rules in any inspection authorized by the board.
(C) The system provides a means to establish and maintaininventories and records of transactions regarding the receiptand distribution or other disposition of all legend drugs,
including the following:
(i) For legend drugs manufactured by a manufacturer forwhich the wholesale drug distributor is an authorizeddistributor, a pedigree for each distributed legend drug thatleaves the normal distribution chain of custody, asdetermined by rules adopted by the board.
(ii) For legend drugs manufactured by a manufacturer forwhich the wholesale drug distributor is not an authorizeddistributor, a pedigree for each distributed legend drug thatleaves the normal chain of custody.
(iii) After January 1, 2007, and after consulting with thefederal Food and Drug Administration, at the board'sdiscretion, for each legend drug received and distributedby the wholesale drug distributor, an electronic pedigreedeveloped in accordance with standards and requirementsof the board to authenticate, track, and trace legend drugs.The standards and requirements of the board may indicatethe information required to be part of the electronicpedigree.
(iv) Dates of receipt and distribution or other dispositionof the legend drugs by the wholesale drug distributor.
(v) Availability for inspection and photocopying by anyauthorized official of a local, state, or federalgovernmental agency for three (3) years after the creationdate of the inventories and records.
(D) Onsite electronic inventories and records areimmediately available for inspection, and records kept at acentral location apart from the inspection site and notelectronically retrievable are available for inspection withintwo (2) working days after a request by an authorizedofficial of a local, state, or federal governmental agency.
(E) The system maintains an ongoing list of persons withwhom the wholesale drug distributor does business.
(F) The system provides for reporting counterfeit orsuspected counterfeit legend drugs or counterfeiting orsuspected counterfeiting activities to the board and thefederal Food and Drug Administration.
(G) The system provides for mandatory reporting ofsignificant shortages or losses of legend drugs to the boardand the federal Food and Drug Administration, if applicable,if diversion is known or suspected.
(4) Written policies and procedures to which the wholesale drugdistributor adheres for the receipt, security, storage, inventory,transport, shipping, and distribution of legend drugs, and thatassure reasonable wholesale distributor preparation for,protection against, and handling of any facility security oroperation problems, including the following:
(A) Facility security or operation problems caused by naturaldisaster or government emergency.
(B) Correction of inventory inaccuracies. (C) Product shipping and receiving problems.
(D) Quarantine and return to the manufacturer or destructionin accordance with state and federal law of all outdatedproducts and outdated or expired legend drugs, includingappropriate documentation and witnessing.
(E) Appropriate disposition of returned goods.
(F) Product recalls.
(G) Identifying, recording, and reporting losses or thefts.
(H) Recalls and withdrawals of legend drugs due to:
(i) an action initiated by the federal Food and DrugAdministration or another federal, state, or localgovernmental agency;
(ii) a volunteer action by the manufacturer to removedefective or potentially defective legend drugs from themarket; or
(iii) an action undertaken to promote public health andsafety by replacing existing merchandise with an improvedproduct or a new package design.
(I) Disposition and destruction of containers, labels, andpackaging to ensure that the containers, labels, andpackaging are not used in counterfeiting activities, includingnecessary documentation and witnessing in accordance withstate and federal law.
(J) Investigation of discrepancies in the inventory involvingcounterfeit, suspected counterfeit, contraband, or suspectedcontraband legend drugs and reporting of discrepancieswithin three (3) business days to the board and any otherappropriate state or federal governmental agency.
(K) Reporting of criminal or suspected criminal activitiesinvolving the inventory of legend drugs to the board withinthree (3) business days.
(L) Conducting for cause authentication as required undersections 17.2 and 17.8 of this chapter.
(5) Written policies and procedures and sufficient inspectionprocedures for all incoming and outgoing product shipments,including the following:
(A) Upon receipt, visual examination of each shippingcontainer in a manner adequate to identify the legend drugsin the container and to determine whether the legend drugsmay be outdated, adulterated, misbranded, contaminated,contraband, counterfeit, suspected counterfeit, damaged, orotherwise unfit for distribution.
(B) Upon receipt, review of records by the wholesale drugdistributor for the acquisition of legend drugs for accuracyand completeness, considering the:
(i) total facts and circumstances surrounding eachtransaction involving the legend drugs; and
(ii) wholesale drug distributors involved.
(C) Quarantine of a legend drug considered to be outdated,adulterated, misbranded, contaminated, contraband,
counterfeit, suspected counterfeit, damaged, or otherwiseunfit for distribution until:
(i) examination and a determination that the legend drugis not outdated, adulterated, misbranded, contaminated,contraband, counterfeit, damaged, or otherwise unfit fordistribution; or
(ii) the legend drug is destroyed or returned to themanufacturer or wholesale drug distributor from which thelegend drug was acquired.
(D) Written policies and procedures to ensure that if thewholesale drug distributor determines that a legend drug isadulterated, misbranded, counterfeit, or suspectedcounterfeit, the wholesale drug distributor provides notice ofthe adulteration, misbranding, counterfeiting, or suspectedcounterfeiting to the board, the federal Food and DrugAdministration, and the manufacturer or wholesale drugdistributor from which the legend drug was acquired withinthree (3) business days.
(E) Written policies and procedures to ensure that if theimmediate or sealed outer or secondary container or labelingof a legend drug is adulterated, misbranded, counterfeit, orsuspected counterfeit, the wholesale drug distributor:
(i) quarantines the legend drug until the legend drug isdestroyed or returned to the manufacturer or wholesaledrug distributor from which the legend drug was acquired;and
(ii) provides notice of the adulteration, misbranding,counterfeiting, or suspected counterfeiting to the board,the federal Food and Drug Administration, and themanufacturer or wholesale drug distributor from which thelegend drug was acquired within three (3) business days.
(F) Written policies and procedures to ensure that a legenddrug that has been opened or used, but is not adulterated,misbranded, counterfeit, or suspected counterfeit, isidentified as such and quarantined until the legend drug isdestroyed or returned to the manufacturer or wholesale drugdistributor from which the legend drug was acquired.
(G) Written policies and procedures to ensure that:
(i) a legend drug that will be returned to a manufacturer orwholesale drug distributor is kept under proper conditionsfor storage, handling, transport, and shipment before thereturn; and
(ii) documentation showing that proper conditions weremaintained is provided to the manufacturer or wholesaledrug distributor to which the legend drug is returned.
(H) Inspection of each outgoing shipment for identity of thelegend drugs and to ensure that the legend drugs have notbeen damaged in storage or held under improper conditions.
(I) Written policies and procedures to ensure that ifconditions under which a legend drug has been returned to
the wholesale drug distributor cast doubt on the legenddrug's safety, identity, strength, quality, or purity, the legenddrug is destroyed or returned to the manufacturer orwholesale drug distributor from which the legend drug wasacquired unless examination, testing, or other investigationproves that the legend drug meets appropriate standards ofsafety, identity, strength, quality, and purity. In determiningwhether the conditions under which a legend drug has beenreturned cast doubt on the legend drug's safety, identity,strength, quality, or purity, the wholesale drug distributorconsiders the conditions under which the legend drug hasbeen held, stored, or shipped before or during the legenddrug's return and the condition of the legend drug and thelegend drug's container, carton, or labeling upon receipt ofthe returned legend drug.
(J) Written policies and procedures to ensure thatcontraband, counterfeit, or suspected counterfeit legenddrugs, other evidence of criminal activity, and accompanyingdocumentation are retained until a disposition is authorizedby the board and the federal Food and Drug Administration.
(K) Written policies and procedures to ensure that anyshipping, immediate, or sealed outer or secondary containeror labeling, and accompanying documentation, suspected ofor determined to be counterfeit or fraudulent, are retaineduntil a disposition is authorized by the board and the federalFood and Drug Administration.
(6) Operations in compliance with all federal legal requirementsapplicable to wholesale drug distribution.
(7) Written policies and procedures to provide for the secureand confidential storage of information with restricted accessand to protect the integrity and confidentiality of theinformation.
(8) A pedigree as required under this chapter, including anelectronic pedigree developed in accordance with standards andrequirements of the board under subdivision (3)(C)(iii).
(9) Appropriate inventory management and control systems to:
(A) prevent; and
(B) allow detection and documentation of;
theft, counterfeiting, or diversion of legend drugs.
(10) If the wholesale drug distributor is involved in thedistribution of controlled substances, registration with thefederal Drug Enforcement Administration and the board andcompliance with all laws related to the storage, handling,transport, shipment, and distribution of controlled substances.
(11) Isolation of controlled substances from noncontrolledsubstances and storage of the controlled substances in a