Sen. Patricia Van Pelt

Filed: 3/13/2018





10000SB2849sam001LRB100 19083 MJP 36763 a


2    AMENDMENT NO. ______. Amend Senate Bill 2849 by replacing
3everything after the enacting clause with the following:
4    "Section 1. Short title. This Act may be cited as the
5Prescription Drug Repository Program Act.
6    Section 5. Definitions. In this Act:
7    "Controlled substance" means a drug, substance, or
8immediate precursor in Schedules I through V of 21 CFR 1308.
9    "Covered entity" means a long-term care facility licensed
10under the Nursing Home Care Act, an assisted living facility
11licensed under the Assisted Living and Shared Housing Act, a
12shared housing establishment licensed under the Assisted
13Living and Shared Housing Act, a pharmacy, a wholesaler, or a
14manufacturer, located inside or outside of the State.
15    "Department" means the Department of Public Health.
16    "Dispense" has the meaning given to that term in the



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1Pharmacy Practice Act.
2    "Pharmacist" means an individual licensed to engage in the
3practice of pharmacy under the Pharmacy Practice Act.
4    "Pharmacy" means a pharmacy registered in this State under
5the Pharmacy Practice Act.
6    "Practitioner" means a person licensed in this State to
7prescribe and administer drugs or licensed in another state and
8recognized by this State as a person authorized to prescribe
9and administer drugs.
10    "Prescription drug" means any prescribed drug that may be
11legally dispensed by a pharmacy. "Prescription drug" does not
12include drugs for the treatment of cancer that can only be
13dispensed to a patient registered with the drug manufacturer in
14accordance with federal Food and Drug Administration
16    "Program" means the prescription drug repository program
17established under this Act.
18    Section 10. Prescription drug repository program. The
19Department shall, by rule, establish and maintain a
20prescription drug repository program, under which a covered
21entity may donate a prescription drug or supplies needed to
22administer a prescription drug for use by an individual who
23meets appropriate eligibility criteria. The Department shall
24adopt the rules within one year after the effective date of
25this Act. Donations may be made on the premises of a pharmacy



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1that elects to participate in the program and meets appropriate
2requirements. The pharmacy may charge an individual who
3receives a prescription drug or supplies needed to administer a
4prescription drug under this Act a handling fee that may not
5exceed an appropriate amount. A pharmacy that receives a
6donated prescription drug or supplies needed to administer a
7prescription drug under this Act may distribute the
8prescription drug or supplies to another eligible pharmacy for
9use under the program.
10    Section 15. Priority. Uninsured and underinsured
11individuals shall be given priority for drugs and supplies
12donated under this Act over other eligible persons.
13    Section 20. Requirements for accepting and dispensing
14prescription drugs and supplies. A prescription drug or
15supplies needed to administer a prescription drug may be
16accepted and dispensed under the program only if all of the
17following requirements are met:
18        (1) The prescription drug or supplies needed to
19    administer a prescription drug are in their original,
20    unopened, sealed, and tamper-evident packaging or, if
21    packaged in single-unit doses, the single-unit-dose
22    packaging is unopened. Medicine and supplies originally
23    packaged by a pharmacy are acceptable for donation.
24        (2) The prescription drug bears an expiration date that



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1    is later than an amount of time determined by the
2    Department after the date that the drug was donated.
3        (3) The prescription drug or supplies needed to
4    administer a prescription drug are not adulterated or
5    misbranded, as determined by a pharmacist employed by, or
6    under contract with, the pharmacy where the drug or
7    supplies are accepted or dispensed. The pharmacist must
8    inspect the drug or supplies before the drug or supplies
9    are dispensed.
10        (4) The prescription drug or supplies needed to
11    administer a prescription drug are prescribed by a
12    practitioner for use by an eligible individual.
13        (5) The prescription drug is not a controlled
14    substance.
15        (6) Drugs that can be dispensed only to a patient
16    registered with the drug's manufacturer in accordance with
17    federal Food and Drug Administration requirements may not
18    be accepted or distributed under the provisions of the
19    program.
20        (7) A pharmacy shall maintain a written or electronic
21    record of a donation under this Act consisting of the name,
22    strength, and quantity of each accepted drug, and the name,
23    address, and telephone number of the donor. No other record
24    of a donation shall be required.
25    Section 25. Resale of donated drugs or supplies prohibited.



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1No prescription drug or supplies needed to administer a
2prescription drug that are donated for use under this Act may
3be resold.
4    Section 30. Participation in program not required. Nothing
5in this Act requires that a pharmacy or pharmacist participate
6in the prescription drug repository program.
7    Section 90. The Pharmacy Practice Act is amended by
8changing Section 4 as follows:
9    (225 ILCS 85/4)  (from Ch. 111, par. 4124)
10    (Section scheduled to be repealed on January 1, 2020)
11    Sec. 4. Exemptions. Nothing contained in any Section of
12this Act shall apply to, or in any manner interfere with:
13        (a) the lawful practice of any physician licensed to
14    practice medicine in all of its branches, dentist,
15    podiatric physician, veterinarian, or therapeutically or
16    diagnostically certified optometrist within the limits of
17    his or her license, or prevent him or her from supplying to
18    his or her bona fide patients such drugs, medicines, or
19    poisons as may seem to him appropriate;
20        (b) the sale of compressed gases;
21        (c) the sale of patent or proprietary medicines and
22    household remedies when sold in original and unbroken
23    packages only, if such patent or proprietary medicines and



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1    household remedies be properly and adequately labeled as to
2    content and usage and generally considered and accepted as
3    harmless and nonpoisonous when used according to the
4    directions on the label, and also do not contain opium or
5    coca leaves, or any compound, salt or derivative thereof,
6    or any drug which, according to the latest editions of the
7    following authoritative pharmaceutical treatises and
8    standards, namely, The United States
9    Pharmacopoeia/National Formulary (USP/NF), the United
10    States Dispensatory, and the Accepted Dental Remedies of
11    the Council of Dental Therapeutics of the American Dental
12    Association or any or either of them, in use on the
13    effective date of this Act, or according to the existing
14    provisions of the Federal Food, Drug, and Cosmetic Act and
15    Regulations of the Department of Health and Human Services,
16    Food and Drug Administration, promulgated thereunder now
17    in effect, is designated, described or considered as a
18    narcotic, hypnotic, habit forming, dangerous, or poisonous
19    drug;
20        (d) the sale of poultry and livestock remedies in
21    original and unbroken packages only, labeled for poultry
22    and livestock medication;
23        (e) the sale of poisonous substances or mixture of
24    poisonous substances, in unbroken packages, for
25    nonmedicinal use in the arts or industries or for
26    insecticide purposes; provided, they are properly and



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1    adequately labeled as to content and such nonmedicinal
2    usage, in conformity with the provisions of all applicable
3    federal, state and local laws and regulations promulgated
4    thereunder now in effect relating thereto and governing the
5    same, and those which are required under such applicable
6    laws and regulations to be labeled with the word "Poison",
7    are also labeled with the word "Poison" printed thereon in
8    prominent type and the name of a readily obtainable
9    antidote with directions for its administration;
10        (f) the delegation of limited prescriptive authority
11    by a physician licensed to practice medicine in all its
12    branches to a physician assistant under Section 7.5 of the
13    Physician Assistant Practice Act of 1987. This delegated
14    authority under Section 7.5 of the Physician Assistant
15    Practice Act of 1987 may, but is not required to, include
16    prescription of controlled substances, as defined in
17    Article II of the Illinois Controlled Substances Act, in
18    accordance with a written supervision agreement;
19        (g) the delegation of prescriptive authority by a
20    physician licensed to practice medicine in all its branches
21    or a licensed podiatric physician to an advanced practice
22    registered nurse in accordance with a written
23    collaborative agreement under Sections 65-35 and 65-40 of
24    the Nurse Practice Act; and
25        (g-5) the donation or acceptance, or the packaging,
26    repackaging, or labeling, of prescription drugs to the



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1    extent permitted or required under the Prescription Drug
2    Repository Program Act; and
3        (h) the sale or distribution of dialysate or devices
4    necessary to perform home peritoneal renal dialysis for
5    patients with end-stage renal disease, provided that all of
6    the following conditions are met:
7            (1) the dialysate, comprised of dextrose or
8        icodextrin, or devices are approved or cleared by the
9        federal Food and Drug Administration, as required by
10        federal law;
11            (2) the dialysate or devices are lawfully held by a
12        manufacturer or the manufacturer's agent, which is
13        properly registered with the Board as a manufacturer or
14        wholesaler;
15            (3) the dialysate or devices are held and delivered
16        to the manufacturer or the manufacturer's agent in the
17        original, sealed packaging from the manufacturing
18        facility;
19            (4) the dialysate or devices are delivered only
20        upon receipt of a physician's prescription by a
21        licensed pharmacy in which the prescription is
22        processed in accordance with provisions set forth in
23        this Act, and the transmittal of an order from the
24        licensed pharmacy to the manufacturer or the
25        manufacturer's agent; and
26            (5) the manufacturer or the manufacturer's agent



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1        delivers the dialysate or devices directly to: (i) a
2        patient with end-stage renal disease, or his or her
3        designee, for the patient's self-administration of the
4        dialysis therapy or (ii) a health care provider or
5        institution for administration or delivery of the
6        dialysis therapy to a patient with end-stage renal
7        disease.
8        This paragraph (h) does not include any other drugs for
9    peritoneal dialysis, except dialysate, as described in
10    item (1) of this paragraph (h). All records of sales and
11    distribution of dialysate to patients made pursuant to this
12    paragraph (h) must be retained in accordance with Section
13    18 of this Act.
14(Source: P.A. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
15revised 9-29-17.)
16    Section 95. The Wholesale Drug Distribution Licensing Act
17is amended by changing Section 15 as follows:
18    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
19    (Section scheduled to be repealed on January 1, 2023)
20    Sec. 15. Definitions. As used in this Act:
21    "Authentication" means the affirmative verification,
22before any wholesale distribution of a prescription drug
23occurs, that each transaction listed on the pedigree has



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1    "Authorized distributor of record" means a wholesale
2distributor with whom a manufacturer has established an ongoing
3relationship to distribute the manufacturer's prescription
4drug. An ongoing relationship is deemed to exist between a
5wholesale distributor and a manufacturer when the wholesale
6distributor, including any affiliated group of the wholesale
7distributor, as defined in Section 1504 of the Internal Revenue
8Code, complies with the following:
9        (1) The wholesale distributor has a written agreement
10    currently in effect with the manufacturer evidencing the
11    ongoing relationship; and
12        (2) The wholesale distributor is listed on the
13    manufacturer's current list of authorized distributors of
14    record, which is updated by the manufacturer on no less
15    than a monthly basis.
16    "Blood" means whole blood collected from a single donor and
17processed either for transfusion or further manufacturing.
18    "Blood component" means that part of blood separated by
19physical or mechanical means.
20    "Board" means the State Board of Pharmacy of the Department
21of Professional Regulation.
22    "Chain pharmacy warehouse" means a physical location for
23prescription drugs that acts as a central warehouse and
24performs intracompany sales or transfers of the drugs to a
25group of chain or mail order pharmacies that have the same
26common ownership and control. Notwithstanding any other



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1provision of this Act, a chain pharmacy warehouse shall be
2considered part of the normal distribution channel.
3    "Co-licensed partner or product" means an instance where
4one or more parties have the right to engage in the
5manufacturing or marketing of a prescription drug, consistent
6with the FDA's implementation of the Prescription Drug
7Marketing Act.
8    "Department" means the Department of Financial and
9Professional Regulation.
10    "Drop shipment" means the sale of a prescription drug to a
11wholesale distributor by the manufacturer of the prescription
12drug or that manufacturer's co-licensed product partner, that
13manufacturer's third party logistics provider, or that
14manufacturer's exclusive distributor or by an authorized
15distributor of record that purchased the product directly from
16the manufacturer or one of these entities whereby the wholesale
17distributor or chain pharmacy warehouse takes title but not
18physical possession of such prescription drug and the wholesale
19distributor invoices the pharmacy, chain pharmacy warehouse,
20or other person authorized by law to dispense or administer
21such drug to a patient and the pharmacy, chain pharmacy
22warehouse, or other authorized person receives delivery of the
23prescription drug directly from the manufacturer, that
24manufacturer's third party logistics provider, or that
25manufacturer's exclusive distributor or from an authorized
26distributor of record that purchased the product directly from



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1the manufacturer or one of these entities.
2    "Drug sample" means a unit of a prescription drug that is
3not intended to be sold and is intended to promote the sale of
4the drug.
5    "Facility" means a facility of a wholesale distributor
6where prescription drugs are stored, handled, repackaged, or
7offered for sale.
8    "FDA" means the United States Food and Drug Administration.
9    "Manufacturer" means a person licensed or approved by the
10FDA to engage in the manufacture of drugs or devices,
11consistent with the definition of "manufacturer" set forth in
12the FDA's regulations and guidances implementing the
13Prescription Drug Marketing Act. "Manufacturer" does not
14include anyone who is engaged in the packaging, repackaging, or
15labeling of prescription drugs only to the extent required
16under the Prescription Drug Repository Program Act.
17    "Manufacturer's exclusive distributor" means anyone who
18contracts with a manufacturer to provide or coordinate
19warehousing, distribution, or other services on behalf of a
20manufacturer and who takes title to that manufacturer's
21prescription drug, but who does not have general responsibility
22to direct the sale or disposition of the manufacturer's
23prescription drug. A manufacturer's exclusive distributor must
24be licensed as a wholesale distributor under this Act and, in
25order to be considered part of the normal distribution channel,
26must also be an authorized distributor of record.



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1    "Normal distribution channel" means a chain of custody for
2a prescription drug that goes, directly or by drop shipment,
3from (i) a manufacturer of the prescription drug, (ii) that
4manufacturer to that manufacturer's co-licensed partner, (iii)
5that manufacturer to that manufacturer's third party logistics
6provider, or (iv) that manufacturer to that manufacturer's
7exclusive distributor to:
8        (1) a pharmacy or to other designated persons
9    authorized by law to dispense or administer the drug to a
10    patient;
11        (2) a wholesale distributor to a pharmacy or other
12    designated persons authorized by law to dispense or
13    administer the drug to a patient;
14        (3) a wholesale distributor to a chain pharmacy
15    warehouse to that chain pharmacy warehouse's intracompany
16    pharmacy to a patient or other designated persons
17    authorized by law to dispense or administer the drug to a
18    patient;
19        (4) a chain pharmacy warehouse to the chain pharmacy
20    warehouse's intracompany pharmacy or other designated
21    persons authorized by law to dispense or administer the
22    drug to the patient;
23        (5) an authorized distributor of record to one other
24    authorized distributor of record to an office-based health
25    care practitioner authorized by law to dispense or
26    administer the drug to the patient; or



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1        (6) an authorized distributor to a pharmacy or other
2    persons licensed to dispense or administer the drug.
3    "Pedigree" means a document or electronic file containing
4information that records each wholesale distribution of any
5given prescription drug from the point of origin to the final
6wholesale distribution point of any given prescription drug.
7    "Person" means and includes a natural person, partnership,
8association, corporation, or any other legal business entity.
9    "Pharmacy distributor" means any pharmacy licensed in this
10State or hospital pharmacy that is engaged in the delivery or
11distribution of prescription drugs either to any other pharmacy
12licensed in this State or to any other person or entity
13including, but not limited to, a wholesale drug distributor
14engaged in the delivery or distribution of prescription drugs
15who is involved in the actual, constructive, or attempted
16transfer of a drug in this State to other than the ultimate
17consumer except as otherwise provided for by law.
18    "Prescription drug" means any human drug, including any
19biological product (except for blood and blood components
20intended for transfusion or biological products that are also
21medical devices), required by federal law or regulation to be
22dispensed only by a prescription, including finished dosage
23forms and bulk drug substances subject to Section 503 of the
24Federal Food, Drug and Cosmetic Act.
25    "Repackage" means repackaging or otherwise changing the
26container, wrapper, or labeling to further the distribution of



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1a prescription drug, excluding that completed by the pharmacist
2responsible for dispensing the product to a patient.
3    "Secretary" means the Secretary of Financial and
4Professional Regulation.
5    "Third party logistics provider" means anyone who
6contracts with a prescription drug manufacturer to provide or
7coordinate warehousing, distribution, or other services on
8behalf of a manufacturer, but does not take title to the
9prescription drug or have general responsibility to direct the
10prescription drug's sale or disposition. A third party
11logistics provider must be licensed as a wholesale distributor
12under this Act and, in order to be considered part of the
13normal distribution channel, must also be an authorized
14distributor of record.
15    "Wholesale distribution" means the distribution of
16prescription drugs to persons other than a consumer or patient,
17but does not include any of the following:
18        (1) Intracompany sales of prescription drugs, meaning
19    (i) any transaction or transfer between any division,
20    subsidiary, parent, or affiliated or related company under
21    the common ownership and control of a corporate entity or
22    (ii) any transaction or transfer between co-licensees of a
23    co-licensed product.
24        (2) The sale, purchase, distribution, trade, or
25    transfer of a prescription drug or offer to sell, purchase,
26    distribute, trade, or transfer a prescription drug for



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1    emergency medical reasons.
2        (3) The distribution of prescription drug samples by
3    manufacturers' representatives.
4        (4) Drug returns, when conducted by a hospital, health
5    care entity, or charitable institution in accordance with
6    federal regulation.
7        (5) The sale of minimal quantities of prescription
8    drugs by licensed pharmacies to licensed practitioners for
9    office use or other licensed pharmacies.
10        (6) The sale, purchase, or trade of a drug, an offer to
11    sell, purchase, or trade a drug, or the dispensing of a
12    drug pursuant to a prescription.
13        (7) The sale, transfer, merger, or consolidation of all
14    or part of the business of a pharmacy or pharmacies from or
15    with another pharmacy or pharmacies, whether accomplished
16    as a purchase and sale of stock or business assets.
17        (8) The sale, purchase, distribution, trade, or
18    transfer of a prescription drug from one authorized
19    distributor of record to one additional authorized
20    distributor of record when the manufacturer has stated in
21    writing to the receiving authorized distributor of record
22    that the manufacturer is unable to supply the prescription
23    drug and the supplying authorized distributor of record
24    states in writing that the prescription drug being supplied
25    had until that time been exclusively in the normal
26    distribution channel.



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1        (9) The delivery of or the offer to deliver a
2    prescription drug by a common carrier solely in the common
3    carrier's usual course of business of transporting
4    prescription drugs when the common carrier does not store,
5    warehouse, or take legal ownership of the prescription
6    drug.
7        (10) The sale or transfer from a retail pharmacy, mail
8    order pharmacy, or chain pharmacy warehouse of expired,
9    damaged, returned, or recalled prescription drugs to the
10    original manufacturer, the originating wholesale
11    distributor, or a third party returns processor.
12        (11) The donation of prescription drugs to the extent
13    permitted under the Prescription Drug Repository Program
14    Act.
15    "Wholesale drug distributor" means anyone engaged in the
16wholesale distribution of prescription drugs into, out of, or
17within the State, including without limitation manufacturers;
18repackers; own label distributors; jobbers; private label
19distributors; brokers; warehouses, including manufacturers'
20and distributors' warehouses; manufacturer's exclusive
21distributors; and authorized distributors of record; drug
22wholesalers or distributors; independent wholesale drug
23traders; specialty wholesale distributors; third party
24logistics providers; and retail pharmacies that conduct
25wholesale distribution; and chain pharmacy warehouses that
26conduct wholesale distribution. In order to be considered part



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1of the normal distribution channel, a wholesale distributor
2must also be an authorized distributor of record.
3(Source: P.A. 97-804, eff. 1-1-13.)
4    Section 100. The Senior Pharmaceutical Assistance Act is
5amended by changing Section 10 as follows:
6    (320 ILCS 50/10)
7    Sec. 10. Definitions. In this Act:
8    "Manufacturer" includes:
9        (1) An entity that is engaged in (a) the production,
10    preparation, propagation, compounding, conversion, or
11    processing of prescription drug products (i) directly or
12    indirectly by extraction from substances of natural
13    origin, (ii) independently by means of chemical synthesis,
14    or (iii) by combination of extraction and chemical
15    synthesis; or (b) the packaging, repackaging, labeling or
16    re-labeling, or distribution of prescription drug
17    products.
18        (2) The entity holding legal title to or possession of
19    the national drug code number for the covered prescription
20    drug.
21    The term does not include a wholesale distributor of drugs,
22drugstore chain organization, or retail pharmacy licensed by
23the State. The term also does not include anyone who is engaged
24in the packaging, repackaging, or labeling of prescription



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1drugs only to the extent required under the Prescription Drug
2Repository Program Act.
3    "Prescription drug" means a drug that may be dispensed only
4upon prescription by an authorized prescriber and that is
5approved for safety and effectiveness as a prescription drug
6under Section 505 or 507 of the Federal Food, Drug and Cosmetic
8    "Senior citizen" or "senior" means a person 65 years of age
9or older.
10(Source: P.A. 92-594, eff. 6-27-02.)
11    Section 105. The Illinois Food, Drug and Cosmetic Act is
12amended by changing Section 16 as follows:
13    (410 ILCS 620/16)  (from Ch. 56 1/2, par. 516)
14    Sec. 16. (a) The Director is hereby authorized to
15promulgate regulations exempting from any labeling or
16packaging requirement of this Act drugs and devices which are
17(i) , in accordance with the practice of the trade, to be
18processed, labeled or repacked in substantial quantities at
19establishments other than those where originally processed or
20packaged on condition that such drugs and devices are not
21adulterated or misbranded under the provisions of this Act upon
22removal from such processing, labeling or repacking
23establishment or (ii) packaged, repackaged, or labeled to the
24extent required under the Prescription Drug Repository Program



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2    (b) Drugs and device labeling or packaging exemptions
3adopted under the Federal Act and supplements thereto or
4revisions thereof shall apply to drugs and devices in Illinois
5except insofar as modified or rejected by regulations
6promulgated by the Director.
7    (c) A drug intended for use by man which (A) is a
8habit-forming drug to which Section 15 (d) applies; or (B)
9because of its toxicity or other potentiality for harmful
10effect or the method of its use or the collateral measures
11necessary to its use is not safe for use except under the
12supervision of a practitioner licensed by law to administer
13such drug; or (C) is limited by an approved application under
14Section 505 of the Federal Act or Section 17 of this Act to use
15under the professional supervision of a practitioner licensed
16by law to administer such drug, shall be dispensed only in
17accordance with the provisions of the "Illinois Controlled
18Substances Act". The act of dispensing a drug contrary to the
19provisions of this paragraph shall be deemed to be an act which
20results in a drug being misbranded while held for sale.
21    (d) Any drug dispensed by filling or refilling a written or
22oral prescription of a practitioner licensed by law to
23administer such drug shall be exempt from the requirements of
24Section 15, except subsections (a), (k) and (l) and clauses (2)
25and (3) of subsection (i), and the packaging requirements of
26subsections (g), (h) and (q), if the drug bears a label



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1containing the proprietary name or names, or if there is none,
2the established name or names of the drugs, the dosage and
3quantity, unless the prescribing practitioner, in the interest
4of the health of the patient, directs otherwise in writing, the
5name and address of the dispenser, the serial number and date
6of the prescription or of its filling, the name of the
7prescriber and, if stated in the prescription, the name of the
8patient, and the directions for use and the cautionary
9statements, if any, contained in such prescription. This
10exemption shall not apply to any drug dispensed in the course
11of the conduct of business of dispensing drugs pursuant to
12diagnosis by mail, or to a drug dispensed in violation of
13subsection (a) of this Section.
14    (e) The Director may by regulation remove drugs subject to
15Section 15 (d) and Section 17 from the requirements of
16subsection (c) of this Section when such requirements are not
17necessary for the protection of the public health.
18    (f) A drug which is subject to subsection (c) of this
19Section shall be deemed to be misbranded if at any time before
20dispensing its label fails to bear the statement "Caution:
21Federal Law Prohibits Dispensing Without Prescription" or
22"Caution: State Law Prohibits Dispensing Without
23Prescription". A drug to which subsection (c) of this Section
24does not apply shall be deemed to be misbranded if at any time
25prior to dispensing its label bears the caution statement
26quoted in the preceding sentence.



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1    (g) Nothing in this Section shall be construed to relieve
2any person from any requirement prescribed by or under
3authority of law with respect to controlled substances now
4included or which may hereafter be included within the
5classifications of controlled substances cannabis as defined
6in applicable Federal laws relating to controlled substances or
7cannabis or the Cannabis Control Act.
8(Source: P.A. 84-1308.)".