Report Title:

Controlled substances

 

Description:

Amends drug schedules; limits sale amount of products containing certain precursor drugs.

 


HOUSE OF REPRESENTATIVES

H.B. NO.

 

TWENTY-THIRD LEGISLATURE, 2005

 

STATE OF HAWAII

 

 

A BILL FOR AN ACT


 

 

RELATING TO CONTROLLED SUBSTANCES.

 

 

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF HAWAII:

 


     SECTION 1.  Section 329-22, Hawaii Revised Statutes, is amended to read as follows:

     "§329-22  Schedule V.  (a)  The controlled substances listed in this section are included in schedule V.

     (b)  Narcotic drugs containing nonnarcotic active medicinal ingredients.  Any compound, mixture, or preparation containing limited quantities of any of the following narcotic drugs, which also contains one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation, valuable medicinal qualities other than those possessed by the narcotic drug alone:

     (1)  Not more than 200 milligrams of codeine, or any of its salts, per 100 milliliters or per 100 grams;

     (2)  Not more than 100 milligrams of dihydrocodeine, or any of its salts, per 100 milliliters or per 100 grams;

     (3)  Not more than 100 milligrams of ethylmorphine, or any of its salts, per 100 milliliters or per 100 grams;

     (4)  Not more than 2.5 milligrams of diphenoxylate and not less than 25 micrograms of atropine sulfate per dosage unit;

     (5)  Not more than 100 milligrams of opium per 100 milliliters or per 100 grams; and

     (6)  Not more than 0.5 milligram of difenoxin and not less than 25 micrograms of atropine sulfate per dosage unit.

     (c)  Stimulants.  Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture, or preparation that contains any quantity of the following substances having a stimulant effect on the central nervous system, including its salts, isomers, and salts of isomers:

     (1)  Pyrovalerone.

     (2)  Ephedrine, its salts, optical isomers, and salts of optical isomers as the only active ingredient, or in combination with other active ingredients;

     (3)  Pseudoephedrine, its salts, optical isomers, and salts of optical isomers as the only active ingredient, or in combination with other active ingredients; and

     (4)  Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers as the only active ingredient, or in combination with other active ingredients.

    (d)   Not withstanding any other law, a pharmacy may dispense, sell, or distribute without a prescription not more than one package or not more than three grams of any product, mixture, or preparation containing any detectable quantity of ephedrine, pseudoephedrine, phenylpropanolamine, or their salts, isomers or salts of optical isomers provided that:

(1)  It is dispensed, sold, or distributed only by, or under the supervision of, a licensed pharmacist or a registered pharmacy technician, and

(2)  Any person purchasing, or otherwise acquiring any product, mixture, or preparation shall:

(A)  Produce proper identification containing the photograph, printed name, and signature of the individual obtaining the controlled substance; and

(B)         Sign a written log, receipt, or other program or mechanism approved by the administrator, showing the date of the transaction, name of the person, and the amount of the compound, mixture or preparation.

No person shall purchase, receive, or otherwise acquire more than six (6) grams of any product, mixture, or preparation containing any detectable quantity ofephedrine, pseudoephedrine, phenylpropanolamine or their salts, isomers or salts of optical isomers within any thirty-day period, provided, this limit shall not apply to any quantity of such product, mixture or preparation dispensed pursuant to a valid prescription.

(e)Schedule V designation as it applies to compounds, mixtures, or preparations containing any detectable quantity of pseudoephedrine, its salts or optical isomers, or salts of optical isomers, shall not apply to any compounds, mixtures, or preparations which are in liquid, liquid capsule, or gel capsule form if pseudoephedrine is not the only active ingredient.

(f)The Department by rule, may exempt other products from Schedule V if the Administrator finds the products are not used in the illegal manufacture of methamphetamine or other controlled dangerous substances.  A manufacturer of a drug product may apply for removal of the product from the Schedule if the product is determined by the Administrator to have been formulated in such a way as to effectively prevent the conversion of the active ingredient into methamphetamine."

     SECTION 2.  Section 329-38, Hawaii Revised Statutes, is amended by amending subsection (a) to read as follows:

     "§329-38  Prescriptions.  (a)  No controlled substance in schedule II may be dispensed without a written prescription of a practitioner, except:

     (1)  In the case of an emergency situation, a pharmacist may dispense a controlled substance listed in schedule II upon receiving oral authorization from a prescribing practitioner; provided that:

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

          (B)  Within seventy-two 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 pharmacist.  In addition to conforming to the requirements of this subsection, the prescription shall have written on its face "Authorization for Emergency Dispensing".  The written prescription may be delivered to the pharmacist in person or by mail, and if by mail, the prescription must be postmarked within the seventy-two hour period.  Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription, which had earlier been reduced to writing.  The pharmacist shall notify the administrator if the prescribing practitioner fails to deliver a written prescription to the pharmacy within the allotted time.  Failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.  Any physician who fails to deliver a written prescription within the seventy-two hour period shall be in violation of section 329-41(a)(1); or

     (2)  When dispensed directly by a practitioner, other than a pharmacist, to the ultimate user.  The practitioner in dispensing a controlled substance in schedule II shall affix to the package a label showing:

          (A)  The date of dispensing;

          (B)  The name, strength, and quantity issued of the drug;

          (C)  The dispensing practitioner's name and address;

          (D)  The name of the patient;

          (E)  The date the potency of the drug expires if that date is available from the manufacturer or principal labeler; and

          (F)  Directions for use, and cautionary statements, if any, contained in the prescription or as required by law.

           A complete and accurate record of all schedule II controlled substances ordered, administered, prescribed, and dispensed shall be maintained for five years.  Prescriptions and records of dispensing shall otherwise be retained in conformance with the requirements of section 329-36.  No prescription for a controlled substance in schedule II may be refilled[.]; and

     (3)  No prescription for a schedule II controlled substance shall be filled later than the third day following the day of issuance or held at the pharmacy longer than six days after the schedule II prescription has been presented to the pharmacy to be filled."

SECTION 3.  Section 329-38, Hawaii Revised Statutes, is amended by amending subsections (d) and (e) to read as follows:

"(d)  The effectiveness of a prescription for the purposes of this section shall be determined as follows:

(1)  A prescription for a controlled substance shall be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of the practitioner's professional practice.  The responsibility for the proper prescribing and dispensing of controlled substances shall be upon the prescribing practitioner, but a corresponding responsibility shall rest with the pharmacist who fills the prescription.  An order purporting to be a prescription issued not in the usual course of professional treatment or for legitimate and authorized research shall not be deemed a prescription within the meaning and intent of this section, and the person who knowingly fills such a purported prescription, as well as the person who issues the prescription, shall be subject to the penalties provided for violations of this chapter;

(2) A prescription may not be issued to allow an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients;

(3)  A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule for the purpose of "detoxification treatment" or "maintenance treatment" except as authorized under guidelines set forth in title 21 Code of Federal Regulations section 383(g). Nothing in this section shall prohibit a physician or authorized hospital staff from administering or dispensing narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction; and

(4)  An individual practitioner may not prescribe or dispense a substance included in schedule II, III, IV, or V for that individual practitioner's personal use, except in a medical emergency.

(e)  Prescriptions for controlled substances shall be issued only as follows:

(1)  All prescriptions for controlled substances shall originate from within the state, be dated as of, and signed on, the day when the prescriptions were issued and shall bear:

(A)  The full name and address of the patient; and

(B)  The name, address, telephone number, and registration number of the practitioner. 

The controlled substance prescriptions shall be no larger than four and one-half inches by six and one-half inches and no smaller than four inches by five inches.
A practitioner may sign a prescription in the same manner as the practitioner would sign a check or legal document (e.g., J.H. Smith or John H. Smith) and shall use both words and figures (e.g., alphabetically and numerically as indications of quantity, such as five (5)), to indicate the amount of controlled substance to be dispensed.  Where an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or by typewriter and shall be manually signed by the practitioner.  The prescriptions may be prepared by a secretary or agent for the signature of the practitioner, but the prescribing practitioner shall be responsible in case the prescription does not conform in all essential respects to this chapter and any rules adopted pursuant to this chapter.  A corresponding liability shall rest upon a pharmacist who fills a prescription not prepared in the form prescribed by this section;

(2)  An intern, resident, or foreign‑trained physician, or a physician on the staff of a Department of Veterans Affairs facility or other facility serving veterans, exempted from registration under this chapter, shall include on all prescriptions issued by the physician:

(A)  The registration number of the hospital or other institution; and

(B)  The special internal code number assigned to the physician by the hospital or other institution in lieu of the registration number of the practitioner required by this section.

The hospital or other institution shall forward a copy of this special internal code number list to the department as often as necessary to update the department with any additions or deletions.  Failure to comply with this paragraph shall result in the suspension of that facility's privilege to fill controlled substance prescriptions at pharmacies outside of the hospital or other institution.  Each written prescription shall have the name of the.physician stamped, typed, or handprinted on it, as well as the signature of the physician;

(3)  An official exempted from registration shall include on all prescriptions issued by the official:

(A)  The official's branch of service or agency (e.g., "U.S. Army" or "Public Health Service"); and

(B)  The official's service identification number, in lieu of the registration number of the practitioner required by this section.  The service identification number for a Public Health Service employee shall be the employee's social security identification number. 

Each prescription shall have the name of the officer stamped, typed, or handprinted on it, as well as the signature of the officer; and

(4)  A physician assistant registered to prescribe controlled substances under the authorization of a supervising physician shall include on all prescriptions issued:

(A)  The DEA registration number of the supervising physician; and

(B)  DEA registration number of the physician assistant. 

Each written prescription issued shall include the printed, stamped, typed, or [hand-printed] handprinted name, address, and phone number of both the supervising physician and physician assistant, and shall be signed by the physician assistant.  The medical record of each written prescription issued by a physician assistant shall be reviewed and initialed by the physician assistant's supervising physician within seven working days."

SECTION 4.  Section 329-59, Hawaii Revised Statutes, is amended by amending subsection (b) to read as follows:

"(b)  The fund shall consist of all moneys derived from fees collected pursuant to sections 329‑31, 329-67, 329-72, and 329-123(b) and legislative appropriations.  All fees collected pursuant to sections 329‑31, 329-67, 329-72, and 329-123(b) shall be deposited in the controlled substance registration revolving fund."

SECTION 5.  Section 329-64, Hawaii Revised Statutes, is amended by amending subsection (a) to read as follows:

"(a)  The requirements imposed by sections 329-62, [329-63,] 329-63(a), and 329-67 of this part shall not apply to any of the following:

(1)  Any pharmacist or other authorized person who sells or furnishes a substance upon the prescription of a physician, dentist, podiatrist, or veterinarian;

(2)  Any physician, dentist, podiatrist, or veterinarian who administers or furnishes a substance to patients;

(3)  Any manufacturer or wholesaler licensed by the State who sells, transfers, or otherwise furnishes a substance to a licensed pharmacy, physician, dentist, podiatrist, or veterinarian; and

[(4)Any sale, transfer, furnishing, or receipt of any drug which contains ephedrine, pseudoephedrine, norpseudoephedrine, or phenylpropanolamine and which is lawfully sold, transferred, or furnished over the counter without a prescription pursuant to the federal Food, Drug, and Cosmetic Act (21 United States Code Sec. 301 et seq.) or regulations adopted thereunder.

 (5)](4)  Any "dietary supplement" as defined by the federal Food, Drug, and Cosmetic Act (21 United States Code Sec. 301) containing ephedrine alkaloids extracted from any species of Ephedra that meets all of the following criteria:

(A)  It contains, per dosage unit or serving, not more than twenty-five milligrams of ephedrine alkaloids and its labeling does not suggest or recommend a total daily intake of more thanone hundred milligrams of ephedrine alkaloids;

(B)  It contains no hydrochloride or sulfate salts of ephedrine alkaloids;

(C)  It is packaged with a prominent label securely affixed to each package that states all of the following:

(i)  The amount in milligrams of ephedrine alkaloids in a dosage unit or serving;

(ii)   The amount of the dietary supplement that constitutes a dosage unit or serving; and

(iii)   The maximum recommended dosage of ephedrine alkaloids for a healthy adult human is not more than one hundred milligrams in a twenty-four hour period."

SECTION 6.  Section 329-101, Hawaii Revised Statutes, is amended by amending subsection (b) to read as follows:

"(b)  The designated state agency shall determine those schedules of controlled substances, classes of controlled substances, and specific controlled substances and prescription drugs that are purportedly being misused and abused in the State.  No identified controlled substances or prescription drug may be dispensed unless information relevant to the dispensation of the substance is reported electronically or by universal claim form to the central repository established under section 329-102, in accordance with rules adopted by the department."

SECTION 7.  Section 329-102, Hawaii Revised Statutes, is amended by amending subsection (f) to read as follows:

"(f)  All prescriptions for schedule II, III, and IV and other controlled substances and prescription drugs designated by the designated state agency that are processed by an out-of-state pharmacy shall conform to reporting and registration requirements adopted by the State, and to any additional rules the department adopts."

SECTION 8.  Section 329-104, Hawaii Revised Statutes, is amended by amending subsection (c) to read as follows:

"(c)  This section shall not prevent the disclosure, at the

discretion of the administrator, of investigative information to:

(1)  Law enforcement officers, investigative agents of federal, state, or county law enforcement agencies, prosecuting attorneys, or the attorney general; provided that the administrator has reasonable grounds to believe that the disclosure of any information collected under this part is in furtherance of an ongoing criminal investigation or prosecution;

(2)  Registrants authorized under chapters 448, 453, 460 and 463E who are registered to administer, prescribe or dispense controlled substances; provided that the information disclosed relates only to the registrant’s own patient; or

(3)  Pharmacists, employed by a pharmacy registered under section 329-32, who request prescription information about a customer relating to a violation or possible violation of this chapter[.]; and

(4)  Other state governmental authorized prescription monitoring programs.

Information disclosed to a registrant,[or] pharmacist, or authorized government agency under this section shall be [transmitted by certified mail or a similarmeans requiring the registrant’s or pharmacist’s signature, respectively, for delivery of the information.]by a secure means determined by the designated state agency."

SECTION 9.  Statutory material to be repealed is bracketed and stricken.  New statutory material is underscored.

SECTION 10.  This Act shall take effect upon its approval.

 

 

INTRODUCED BY:

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