It is enacted by the General Assembly as follows:

SECTION 1. Section 21-31-15 of the General Laws in Chapter 21-31 entitled "Rhode Island Food, Drugs, and Cosmetics Act" is hereby amended to read as follows:

{ADD 21-31-15. Misbranded drug or device. -- ADD} A drug or device shall be deemed to be misbranded:

(a) If its labeling is false or misleading in any particular.

(b) If in package form unless it bears a label containing (1) the name and place of business of the manufacturer, packer, or distributor; and (2) an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided, that under clause (2) of this subdivision reasonable variations shall be permitted, and exemptions as to small packages shall be established, by regulations prescribed by the director of health.

(c) If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

(d) If it is for use by humans and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or sulphonmethane, or any chemical derivative of such a substance, which derivative has been by the director of health after investigation found to be, and by regulations under this chapter designated as, habit forming, unless its label bears the name and quantity of proportion of the substance or derivative and in juxtaposition therewith the statement "Warning--May be habit forming."

(e) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears (1) the common or usual name of the drug, if such there be; and (2) in case it is fabricated from two or more ingredients, the common or usual name of each active ingredient, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetphenetidin, amidopyrine, anti-pyrine, atropine, hyoseine, hyoscyamine, arsenic, digitalis, glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances contained therein; provided, that to the extent that compliance with the requirements of clause (2) of this subdivision is impracticable, exemptions shall be established by regulations promulgated by the director of health.

(f) Unless its labeling bears (1) adequate directions for use; and (2) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form as are necessary for the protection of users; provided, that where any requirement of clause (1) of this subdivision, as applied to any drug or device, is not necessary for the protection of the public health, the director of health shall promulgate regulations exempting the drug or device from those requirements.

(g) If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein; provided, that the method of packing may be modified with the consent of the director of health. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States, and not to those of the United States Pharmacopoeia.

(h) If it has been found by the director of health to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the director of health shall by regulations require as necessary for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the director of health shall have informed the appropriate body charged with the revision of the compendium of the need for such packaging or labeling requirements and that body shall have failed within a reasonable time to prescribe such requirements.

(i)(1) If it is a drug and its container is so made, formed, or filled as to be misleading; or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug.

(j) If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in its labeling.

(k)(1) A drug intended for use by humans which;

(A) is a habit forming drug to which subdivision (d) of this section applies, or

(B) because of its toxicity or the potential for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer that drug, or

(C) is limited by an effective application under section 21-31-16 to use under the professional supervision of a practitioner licensed by law to administer that drug shall be dispensed only;

(1) upon a written prescription of a practitioner licensed by law to administer the drug, or

(2) upon an oral prescription of the practitioner which is reduced promptly to writing and filed by the pharmacist, or

(3) by refilling any such written or oral prescription if the refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this subdivision shall be deemed to be an act which results in the drug being misbranded while held for sale.

(2) The director of health may by regulation remove drugs subject to subdivision (d) of this section and section 21-31-16 from the requirements of subdivision (1) when such requirements are not necessary for the protection of the public health.

(3) A drug which is subject to subdivision (K)(1) shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement "Caution: Federal law prohibits dispensing without prescription." A drug to which subdivision (k)(1) does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the caution statement quoted in the preceding sentence.

(4) No prescription for any of the drugs described above shall be refilled if marked "non-repeat" or "N.R."

(l)(1) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to prescribe such drug, and any drug dispensed to an ultimate user by a practitioner, shall be exempt from the requirements of this section except subdivisions (a), (i) and (k), and the packaging requirements of subdivisions (g), (h), and (m), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient, and the directions for use and cautionary statements, if any, contained in the prescription. This exemption shall not apply to any drug dispensed in violation of subdivision (k)(1).

{ADD (A) When dispensing a generic drug product, the word "INTERCHANGE" or the letters "IC" must appear on the label followed by the generic name and manufacturer, and/or distributor, of the chosen product. ADD}

{ADD (B) The requirements of subdivision (A) only apply to single entity, multiple-source drugs. ADD}

{ADD (C) When dispensing a single entity, single source drug, the trade name of the prescribed drug will appear on the label, and the generic name of the prescribed drug shall also appear on the label. ADD}

{ADD (D) When dispensing a fixed combination product, the United States Pharmacopoeia's publication of Pharmacy Equivalent Names (PEN Names) for fixed combination products is the official list of abbreviations for such labeling, and will be the approved abbreviation for identifying the combination product dispensed. If no PEN name has been officially issued by the USP, the practitioner or pharmacist will label the medication secundum artem. ADD}

{ADD (E) Subsection (A)-(D) apply in all cases of dispensing by practitioners or pharmacists. ADD}

(2) Nothing in this section shall be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or which may hereafter be included within the classifications stated in chapters 28, and 30 of this title.

(m) If it is a drug and its packaging or labeling is in violation of an applicable regulation issued pursuant to section 23-24.1-3 or 23-24.1-4 of the Poison Prevention Packaging Act.

SECTION 2. Section 21-28-3.18 of the General Laws in Chapter 21-28 entitled "Uniform Controlled Substances Act" is hereby amended to read as follows:

{ADD 21-28-3.18. Prescriptions. -- ADD} (a) An apothecary in good faith may sell and dispense controlled substances in schedule II to any person upon a written prescription, by a practitioner licensed by law to prescribe or administer such substances, dated and signed by the person prescribing on the day when issued and bearing the full name and address of the patient to whom, or of the owner of the animal for which the substance is dispensed and the full name, address and registration number under the federal law of the person prescribing, if he or she is required by that law to be so registered. If the prescription is for an animal, it shall state the species of the animal for which the substance is prescribed.

(b) The apothecary filling the prescription shall sign his or her full name and shall write the date of filling on the face of the prescription.

(c) The prescription shall be retained on file by the proprietor of the pharmacy in which it was filled for a period of two (2) years so as to be readily accessible for inspection by any public officer or employee engaged in the enforcement of this chapter.

(d) Prescriptions for controlled substances in schedule II shall be filed separately and shall not be refilled. The form of record for prescription slips for controlled substances in schedule II shall consist of two (2) parts, an original and a duplicate which are required to be presented to the pharmacy by the ultimate user or his or her representative.

Pharmacies dispensing controlled substances in schedule II are required to deliver to the division of drug control all duplicate copies of such prescriptions on or before the fifth day of the month following the date of dispensing. The prescription slip shall be a form provided by the director of health.

(e) An apothecary, in lieu of a written prescription, may sell and dispense controlled substances in schedules III, IV, and V to any person, upon an oral prescription of a practitioner. In issuing an oral prescription the prescriber shall furnish the apothecary with the same information as is required by subsection (a) in the case of a written prescription for controlled substances in schedule II, except for the written signature of the person prescribing, and the apothecary who fills the prescription, shall immediately reduce the oral prescription to writing and shall inscribe the information on the written record of the prescription made. This record shall be filed and preserved by the proprietor of the pharmacy in which it is filled in accordance with the provisions of subsection (c). In no case may a prescription for a controlled substance listed in schedules III, IV, or V be filled or refilled more than six (6) months after the date on which the prescription was issued and no prescription shall be authorized to be refilled more than five (5) times. Each refilling shall be entered on the face or back of the prescription and note the date and amount of controlled substance dispensed, and the initials or identity of the dispensing apothecary.

(f) In the case of an emergency situation as defined in federal law, an apothecary may dispense a controlled substance listed in schedule II upon receiving an oral authorization of a prescribing practitioner provided that:

(1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period and dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing practitioner.

(2) The prescription shall be immediately reduced to writing and shall contain all the information required in subsection (a).

(3) The prescription must be dispensed in good faith in the normal course of professional practice.

(4) Within seventy-two (72) hours after authorizing an emergency oral prescription, the prescribing practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing apothecary. The prescription shall have written on its face "Authorization for emergency dispensing" and the date of the oral order. The written prescription upon receipt by the apothecary shall be attached to the oral emergency prescription which had earlier been reduced to writing.

(g) The partial filling of a prescription for a controlled substance listed in schedule II is permissible, if the apothecary is unable to supply the full quantity called for in a written prescription or emergency oral prescription and he or she makes a notation of the quantity supplied on the face of the written prescription or oral emergency prescription which has been reduced to writing. The remaining portion of the prescription may be filled within seventy-two (72) hours of the first partial filling, however, if the remaining portion is not, or cannot be filled within seventy-two (72) hours, the apothecary shall notify the prescribing practitioner. No further quantity may be supplied beyond seventy-two (72) hours without a new prescription.

(h) Automated data processing systems. As an alternative to the prescription recordkeeping provision of subsection (e), an automated data processing system may be employed for the recordkeeping system, if the following conditions have been met:

(1) The system shall have the capability of producing sight-readable documents of all original and refilled prescription information. The term "sight-readable" means that an authorized agent shall be able to examine the record and read the information. During the course of an on-site inspection, the record may be read from the CRT, microfiche, microfilm, printout, or other method acceptable to the director. In the case of administrative proceedings, records must be provided in paper printout form.

(2) Such information shall include, but not be limited to, the prescription requirements and records of dispensing as indicated in subsection (e).

(3) The individual pharmacist responsible for completeness and accuracy of the entries to the system must provide documentation of the fact that prescription information entered into the computer is correct. In documenting this information, the pharmacy shall have the option to either:

(A) Maintain a bound log book, or separate file, in which each individual pharmacist involved in the dispensing shall sign a statement each day, attesting to the fact that the prescription information entered into the computer that day has been reviewed and is correct as shown. The book or file must be maintained at the pharmacy employing such a system for a period of at least two (2) years after the date of last dispensing; or

(B) Provide a printout of each day's prescription information. That printout shall be verified, dated, and signed by the individual pharmacist verifying that the information indicated is correct. The printout must be maintained at least two (2) years from the date of last dispensing.

(4) An auxillary recordkeeping system shall be established for the documentation of refills, if the automated data processing system is inoperative for any reason. The auxillary system shall ensure that all refills are authorized by the original prescription, and that the maximum number of refills is not exceeded. When this automated data processing system is restored to operation, the information regarding prescriptions filled and refilled during the inoperative period, shall be entered into the automated data processing system within 96 hours.

(5) Any pharmacy using an automated data processing system must comply with all applicable state and federal laws and regulations.

(6) A pharmacy shall make arrangements with the supplier of data processing services or materials to ensure that the pharmacy continues to have adequate and complete prescription and dispensing records if the relationship with such supplier terminates for any reason. A pharmacy shall ensure continuity in the maintenance of records.

(7) The automated data processing system shall contain adequate safeguards for security of the records, to maintain the confidentiality and accuracy of the prescription information. Safeguards against unauthorized changes in data after the information has been entered and verified by the registered pharmacist shall be provided by the system.

(i) Prescriptions for controlled substances as found in schedules II, III, and IV of section 21-28-2.08 will become void unless dispensed within seven (7) days of the original date of the prescription. The prescriptions in schedules III, and IV cannot be written for more than one hundred (100) dosage units and not more than one hundred (100) dosage units may be dispensed at one time. {ADD For purposes of this section, a dosage unit shall be defined as a single capsule, tablet or suppository, or not more than one (1) teaspoon of an oral liquid. ADD}

(j) Prescriptions for controlled substances as found in schedule II may be written for up to a 30-day supply, with a maximum of two hundred and fifty (250) dosage units, as determined by the prescriber's directions for use of the medication. In no event shall more than a 30-days' supply, up to a maximum of two hundred and fifty (250) dosage units, be dispensed at one time.

SECTION 3. This act shall take effect upon passage.