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August 28, 2016 New Hampshire Pharmacy Law Part-1 Updates/Corrections


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Section 1 Question 2 Answer and Explanation Are Updated.

All I only, [New Hampshire Statutes Chapter 318 Section 318-16a(I),(II)].
 
For a pharmacist to participate in a collaborative pharmacy practice agreement, the pharmacist shall:
 
(a). Hold an unrestricted and current license to practice as a pharmacist in New Hampshire.
 
(b). Have at least $1,000,000 of professional liability insurance coverage.
 
(c). Have earned a Pharm.D. degree or completed 3 years of institutional clinical experience as a licensed pharmacist.
 
(d). Complete at least 5 contact hours or 0.5 continuing education units of Board-approved continuing education each year.
 
Such continuing education shall address the area or areas of practice generally related to the collaborative pharmacy practice agreement or agreements.
 
The continuing education hours may be applied to the requirements for licensure as a pharmacist in this state.
 
(e). In order to administer drugs by injection, have completed training that includes programs approved by the Accreditation Council for Pharmacy Education (ACPE) or curriculum-based programs from an ACPE-accredited college of pharmacy or state or local health department programs or programs recognized by the Board.
Collaborative pharmacy practice agreements shall be reviewed, at least every 2 years, by both the pharmacist and the practitioner, and may be terminated, in writing, by either party.
 
For a pharmacist to participate in a collaborative pharmacy practice agreement, the pharmacist shall:

(a). Hold an unrestricted and current license to practice as a pharmacist in New Hampshire.

 (b). Have at least $1,000,000 of professional liability insurance coverage.

 (c). Have the knowledge base necessary for proper monitoring, including, but not limited to, associated disease states, relevant laboratory tests, adverse events, drug and food interactions, safety, and efficacy. Depending upon the complexity of the services being provided, the pharmacist may be required to have additional credentials or training and shall demonstrate the receipt of approval by the board of pharmacy.

II. Any practitioner with prescriptive authority who holds an active, unrestricted license in the state of New Hampshire may enter into a collaborative pharmacy practice agreement. A service authorized by a practitioner to be performed by a pharmacist under a collaborative pharmacy practice agreement must be within the practitioner's current scope of practice.

 III. Collaborative pharmacy practice agreements may be between single or multiple pharmacists and a single or multiple practitioners.

 IV. Collaborative pharmacy practice agreements shall meet the following general requirements:

 (a). Each protocol developed pursuant to the collaborative pharmacy practice agreement shall contain detailed direction concerning the services that the pharmacist may perform for patients. The protocol shall include, but not be limited to:

 (1). The specific drug or drugs to be managed by the pharmacist.

 (2). The terms and conditions under which drug therapy may be implemented, modified, or discontinued.

 (3). The conditions and events upon which the pharmacist is required to notify the collaborating practitioner and the manner and time frame in which notification will occur.

 (4). The laboratory tests that may be ordered in accordance with medication therapy management.

 (5). Activities which may be performed by the pharmacist in conjunction with the protocol, which shall be documented as specified in the protocol.

 (6). A statement of the expected amount of time the pharmacist will dedicate to performing duties specified under the protocol.

 (b). Collaborative pharmacy practice agreements shall state the beginning and ending dates of the period of time during which the agreement is in effect, and may be terminated, in writing, by either party at any time.

Collaborative pharmacy practice agreements shall be renewed at a minimum every 2 years. When collaborative pharmacy practice agreements are terminated, the patient shall be informed and provided with details to allow for the uninterrupted continuation of their medication therapy management regimen.

Section 1 Question 9 Explanation Is Changed.

Emergency contraception means an elevated dose of hormones used to prevent pregnancy. A pharmacist may initiate emergency contraception drug therapy in accordance with standardized procedures or protocols developed by the Board.
 
Any pharmacist initiating emergency contraception drug therapy shall complete a minimum of 0.2 CEU’s, 2 didactic/live hours, of approved training and education prior to participating in the delivery of emergency contraception drug therapy.
 
For each emergency contraception drug therapy initiated, the pharmacist shall provide each recipient of the emergency contraceptive drug with a standardized fact sheet that includes, but is not limited to:
 
1. The indications for the use of the drug,
 
2. The appropriate method for using th drug,
 
3. Information on the importance of follow-up health care, and
 
4. Health care referral information. 
 
An "emergency contraception' means an elevated dose of hormones used to prevent pregnancy.
 
II. A pharmacist may initiate emergency contraception drug therapy in accordance with standardized procedures or protocols developed by the board, adopted pursuant to RSA 541-A, and an authorized prescriber who is acting within his or her scope of practice.
 
 III. Prior to performing any procedure authorized under this section, a pharmacist shall successfully complete emergency contraception drug therapy education and training in accordance with continuing education requirements established by the board. A pharmacist who has had sufficient recent education and training in emergency contraception may be exempted from the requirements of this section.
 
IV. For each emergency contraception drug therapy initiated pursuant to this section, the pharmacist shall provide each recipient of the emergency contraceptive drugs with a standardized fact sheet that includes, but is not limited to: the indications for the use of the drug, the appropriate method for using the drug, information on the importance of follow-up health care, and health care referral information. The board shall develop this fact sheet in consultation with the commissioner of the department of health and human services, the American College of Obstetricians and Gynecologists, and other relevant health care organizations.
 
 V. Nothing in the section shall affect the requirements of existing law relating to maintaining the confidentiality of medical records.
 
 VI. Nothing in this section shall limit the manner in which emergency contraception can be dispensed.

Section 1 Question 24 Answer And Explanation Are Updated.

In case of unauthorized refills, the dispensed quantity of refilled drug should be limited to a three-day supply (72-hour) thirty-day (30-day) supply.
 
The pharmacist shall inform the prescribing practitioner of the limited emergency supply, provided to the patient, at the earliest reasonable time, [New Hampshire State Pharmacy Administrative Rules Section 704.15(c),(e)].

Section 2 Question 7 Explanation Is Updated.

(c). The quantity of prescription drug dispensed does not exceed a 72-hour 30-day supply as specified on the original prescription;
 
Section 2 Question 17 Explanation Is Updated.
 
The record of that inventory shall be retained in the pharmacy for a minimum of 4 years 2 years.

Section 2 Question 18 Question And Explanation Are Updated.

II. At least 0.5 CEUs of these 1.5 CEUs shall be earned in a didactic live setting.

Section 2 Question 19 Entire Question Is Updated.

Which of the following information is/are TRUE under the New Hampshire State Pharmacy Administrative Rules?
 
I. Three glove fingertip tests shall be performed initially then annually for low and medium risk compounding.
 
II. Three glove fingertip tests  shall be performed  initially then every 6 months for high risk compounding.
 
III. Media fill tests shall be performed every 6 months for high risk compounding.
 
a. I only
b. I and II only
c. II and III only
d. All
 
Answer: All, [New Hampshire State Pharmacy Administrative Rules Section 404.05].
 
(a)  Each compounder shall maintain documentation that confirms staff training and competency related to proper garbing and hand hygiene, aseptic technique and related practices, and cleaning and disinfection procedures prior to compounding of any actual sterile product preparation.
 
(b)  Each compounder shall maintain documentation that confirms that the compounder tests aseptic techniques of all staff that compounds sterile products by preparing media fill units per USP standards.
 
(c)  Each compounder shall maintain documentation that confirms all staff that compounds sterile products are pre-qualified using media fills before compounding of actual drug preparations.
 
(d)  When a positive media fill occurs, compounder shall perform a comprehensive investigation to identify root cause, and document the finding.
 
(e)  When a positive media fill occurs, compounder shall institute corrective and preventive action, and document the corrective action.
 
(f)  Each compounder shall verify that all personnel who compound sterile products are complying with gowning, gloving, and glove-tip processes consistent with USP standards by meeting the following requirements:
 
(1)  Three glove fingertip tests shall be performed initially then annually for low and medium risk compounding;
 
(2)  Three glove fingertip tests  shall be performed  initially then every 6 months for high risk compounding; and
 
(3)  Media fill tests shall be performed every 6 months for high risk compounding.
 
(g) Each compounder shall perform routine surface microbiological and fungal environmental monitoring to minimize contamination at least every 6 months, or in accordance with facilities policies. 
 
(h) Each compounder shall perform comprehensive investigations of out-of-limit findings, as recommended by USP standards to determine root cause, followed by corrective and preventative actions at least weekly. Each compounder shall maintain all documentation of its findings.
 
(i) Each compounder shall perform, at least semi-annually, viable particle testing in primary engineering controls, such as laminar flow workbench, biological safety cabinet and room air according to USP standards.
 
(j)  Each compounder shall ensure that all compounded sterile products that require refrigeration are stored in appropriate refrigeration at all times.
 
(k)  When a compounder assigns a BUD for a sterile product that exceeds BUD limits established in USP standards, a compounder shall have laboratory testing results that support extended expiration dating for compounded sterile preparations to any patient or organization that request such documentation. 
 
(l)  Each compounder shall perform studies to determine extended expiration dates, using evidence-based and validated stability testing procedures, for compounded sterile preparations for which no extended expiration evidence exists.
 
(m)  Each compounder shall have a policy that requires validation of new or changed facilities, equipment, processes, container types, for sterility, and repeatability.
 
(n) Each compounder shall have a quality assurance program to promptly address equipment problems.

Section 2 Question 27 Entire Question Is Updated.

A practitioner other than a veterinarian, in good faith, in the course of his professional practice, and for a legitimate medical purpose, may administer and prescribe controlled drugs, or the practitioner may cause the same to be administered by a nurse or intern under his direction and supervision. In a bona fide emergency situation, the practitioner may dispense a controlled drug to a patient under his care but only in a quantity not to exceed a 7-day supply for all schedule II substances.
 
False, [New Hampshire Statutes Chapter 318-B Section 318-B:10(I)].
 
I. A practitioner other than a veterinarian, in good faith, in the course of his professional practice, and for a legitimate medical purpose, may administer and prescribe controlled drugs, or the practitioner may cause the same to be administered by a nurse or intern under his direction and supervision. In a bona fide emergency situation, the practitioner may dispense a controlled drug to a patient under his care but only in a quantity not to exceed a 48-hour supply (Not 7-day supply) for all schedule II substances or a 7-day supply of schedule III, IV, or V substances.
 
II. A veterinarian, in good faith, in the course of his professional practice only, and not for use by a human being, may administer and prescribe controlled drugs, and the veterinarian may cause them to be administered to an animal under his care, but only in a quantity not to exceed a 48-hour supply of a schedule II substance or a 7-day supply of schedule III, IV, or V substances.

Section 2 Question 29 Explanation Is Updated.

I. The board shall design, establish, and contract with a third party for the implementation and operation of an electronic system to facilitate the confidential sharing of information relating to the prescribing and dispensing of schedule II-IV controlled substances, by prescribers and dispensers within the state.
 
II. All costs incurred by the board for the implementation and operation of the program shall be supported through grants, gifts, or user contributions. The board may charge a fee to individuals who request their own prescription information. The amount charged for an individual's request for his or her prescription information shall not exceed the actual cost of providing that information.
 
III. There shall be no state general funds appropriated for the implementation or operation of the program.
 
IV. Prescription information relating to any individual, which information does not meet the level established to suggest possible drug abuse or diversion shall be deleted within 6 months after the initial prescription was dispensed. All other information shall be deleted after 3 years.
 
I. The board shall develop a system of registration for all prescribers and dispensers of schedule II-IV controlled substances within the state. The system of registration shall be established by rules adopted by the board, pursuant to RSA 541-A.

II. All prescribers and dispensers authorized to prescribe or dispense schedule II-IV controlled substances within the state shall be required to register with the program as follows:

(a) Practitioners who prescribe but do not dispense schedule II-IV controlled substances shall register with the program as a prescriber;

 (b) Practitioners who dispense but do not prescribe schedule II-IV controlled substances shall register with the program as a dispenser unless exempted pursuant to RSA 318-B:31, IV; and

 (c) Practitioners who prescribe and dispense schedule II-IV controlled substances shall register with the program as both a prescriber and a dispenser unless exempted pursuant to RSA 318-B:31, IV.

II-a. Only registered prescribers, dispensers, or their designees, and federal health prescribers and dispensers working in federal facilities located in New Hampshire, Massachusetts, Maine, and Vermont shall be eligible to access the program.

III. Each dispenser shall submit to the program the information regarding each dispensing of a schedule II-IV controlled substance. Any dispenser located outside the boundaries of the state of New Hampshire and who is licensed and registered by the board shall submit information regarding each prescription dispensed to a patient who resides within New Hampshire.

Section 2 Question 30 Explanation Is Updated.

Each dispenser shall submit the required information in accordance with transmission methods and frequency as established by the program; but no more than 7 days daily by the close of business on the next business day from the date the prescription was dispensed. 

Section 3 Question 4 Explanation Is Updated.

True, [New Hampshire State Pharmacy Administrative Rules Section 703.04(a)].
The pharmacist-in-charge shall notify the Board by phone within 72 hours of the loss, followed by a written report signed by the pharmacist-in-charge, on DEA Form 106, and mailed to the Board not later than 15 days after the pharmacist-in-charge discovered that controlled drugs were missing from his or her pharmacy.
 
False, [New Hampshire State Pharmacy Administrative Rules Section 703.03(a)].
The pharmacist-in-charge or pharmacist on duty shall report to the board in writing, any theft or significant loss of controlled substances within one business day.  The pharmacist-in-charge shall complete a New Hampshire Drug Loss Form (revised 5/2015) or DEA 106 Form and mail or fax to the board as soon as the investigation into the loss is complete or within 30 days of the discovery of the loss.

Section 3 Question 7 Entire Question Is Updated.

In any computerized system employed by a user pharmacy, the central recordkeeping location shall be capable of sending the printout to the pharmacy within 48 hours.
 
True, [New Hampshire State Pharmacy Administrative Rules Section 703.04(j)].
 
All pharmacies shall have an automated data processing system to be used for the storage of original, faxed or written prescriptions and the retrieval of refill information for all prescription orders including, but not limited to, controlled substances in schedules II, III, IV, and V, as defined in 21 CFR 1308.11-1308.15 subject to the following conditions:
 
(a).  The system shall provide security against improper manipulation or alteration of stored records.  Individual access codes shall be unique to each licensed location and shall not be available to any other location;
 
(b).  A pharmacy shall make arrangements with the supplier of data processing services or materials to assure that the pharmacy continues to have access to the complete prescription and dispensing records if the relationship with such supplier terminates for any reason.  A pharmacy shall assure continuity in the maintenance of records for the protection of public health;
 
(c).  Any computerized system shall provide on-line retrieval, via electronic display or hard-copy printout, of all prescription records processed at that licensed location;
 
(d).  The information required by (c) above shall include:
 
(1).  The original prescription number;
 
(2). The date of issuance of the original prescription order by the practitioner;
 
(3).  The full name and address of the patient;
 
(4).  The name, address, and DEA registration number of the practitioner, when applicable;
 
(5).  The name, strength, dosage form, quantity prescribed, and quantity dispensed if different from the quantity prescribed, and the total number of refills authorized by the prescribing practitioner, if any; and
 
(6). The date each fill is dispensed.
 
(e).  Any computerized system shall also provide on-line retrieval, via electronic display or hard-copy printout, of the current refill history of all prescription orders including controlled substances in schedules III, IV, and V;
 
(f). This refill history shall include:
 
(1). The name of the drug;
 
(2). The date of refill;
 
(3). The quantity dispensed;
 
(4). The identification code, or name or initials of the dispensing pharmacist for each refill; and
 
(5). The total number of refills dispensed to date for that prescription order;
 
(g).  Documentation of the fact that the refill information entered into the computer each time a pharmacist refills an original prescription order, including refill orders for a schedule III, IV, or V controlled substances is correct shall be provided by:
 
(1).  A hard-copy printout of each day's controlled substance prescription order refill data which shall be verified, dated, and signed by each pharmacist who refilled such prescription orders; or
 
(2).  In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown.
 
(j). In any computerized system employed by a user pharmacy, the central recordkeeping location shall be capable of sending the printout to the pharmacy within 48 hours;
 
(k).  Each pharmacy using an automated data processing system shall maintain on file a hard copy of all controlled substance prescriptions in schedules II, III, IV and V, excluding electronic, preserving all information contained on the original written or oral prescription.  Any computer generated material shall be affixed to the rear of the prescription, leaving the face of the prescription intact.

Section 3 Question 13 Entire Question Is Updated.

Existing pharmacy permit holders who have a sudden loss of the pharmacist-in-charge (PIC), shall be issued a special pharmacy permit valid for 60 days while a new PIC is identified and appears before the board.
 
True, [New Hampshire State Pharmacy Administrative Rules Section Ph 306.05].
 
Existing pharmacy permit holders who have a sudden loss of the pharmacist-in-charge (PIC), shall be issued a special pharmacy permit valid for 60 days while a new PIC is identified and appears before the board.

Section 3 Question 14 Entire Question Is Updated.

Hard copies of prescription records and reports shall not be required to be maintained if they can be reproduced on demand with the exception of Schedule II – V controlled substance prescriptions not presented in electronic format.
 
True, [New Hampshire State Pharmacy Administrative Rules Section Ph 703.01(b),(c)].
 
Hard copies of prescription records and reports shall not be required to be maintained if they can be reproduced on demand with the exception of Schedule II – V controlled substance prescriptions not presented in electronic format.
 
Hardcopy prescriptions for Schedule II –V controlled substances shall be kept on file for 4 years.

Section 3 Question 15 Entire Question Is Updated.

Pharmacists looking to serve as a Pharmacist-in-Charge (PIC) shall:
 
I.  Have worked as a pharmacist for a minimum of 4 years post-graduation.
 
II. Work a minimum of 20 hours per week at the location where he/she serves as PIC .
 
III. Complete and pass with a minimum of 80% an exam designed by the board to assess the knowledge of the candidate in regard to their responsibilities as PIC.
 
II and III, [New Hampshire State Pharmacy Administrative Rules Section 704.11(a)].
 
(a). Pharmacists looking to serve as a Pharmacist-in-Charge (PIC) shall:
 
(1). Have worked as a pharmacist for a minimum of 2 years (not 4-years) post-graduation;
 
(2). Complete and pass with a minimum of 80% an exam designed by the board to assess the knowledge of the candidate in regard to their responsibilities as PIC; and
 
(3). Work a minimum of 20 hours per week at the location where he/she serves as PIC except when absent due to scheduled vacation or other authorized leave.
 
(b). Pharmacist in charge duties shall include:
 
(1). Responsibility for the control of all drugs issued or dispensed in the pharmacy where he/she practices;
 
(2). Ensuring written policies and procedures for the procurement, storage, compounding and dispensing of drugs are in place;
 
(3). Ensuring that all staff pharmacists are familiar with and in compliance with the established policies and procedures;
 
(4). Establishing and supervising the recordkeeping system for the purchase, sale, possession, storage, and repackaging of drugs;
 
(5). Maintaining the security of the prescription department and its contents; (6). Determining who will have keys and access to the pharmacy with the exception of security personnel;
 
(7). Establishing quality assurance guidelines to ensure the medication dispensed is in conformance with the prescription received;
 
(8). Prohibiting the presence of adulterated or misbranded drugs in the pharmacy;
 
(9). Ensuring compliance with the provisions of RSA 318 and RSA 318-B and any other state or federal pharmacy-related laws or rules;
 
(10). Supervising personnel in the prescription department; and
 
(11). Ensuring all personnel involved in the preparation and dispensing of prescriptions are properly licensed or registered with the board.

Section 3 Question 16 Entire Question Is Updated.

Which of the following shall be done by a pharmacist in charge after loss or theft of controlled substances?
 
I. The pharmacist-in-charge or pharmacist on duty shall report to the board in writing, any theft or significant loss of controlled substances within one business day.
 
II. The pharmacist-in-charge shall complete a New Hampshire Drug Loss Form or DEA 106 Form and mail or fax to the Board as soon as the investigation into the loss is complete or within 30 days of the discovery of the loss.
 
III. The report shall include identity and quantity of the missing drugs.
 
All, [http://www.nh.gov/pharmacy/laws/time_limits.htm].
 
The pharmacist-in-charge or pharmacist on duty shall report to the board in writing, any theft or significant loss of controlled substances within one business day.
 
The pharmacist-in-charge shall complete a New Hampshire Drug Loss Form (revised 5/2015) or DEA 106 Form and mail or fax to the Board as soon as the investigation into the loss is complete or within 30 days of the discovery of the loss.

Section 3 Question 18 Explanation and Answer Is Updated.

True False, [New Hampshire State Pharmacy Administrative Rules Section 705.03 705.02(d)(3)].
 
4. Controlled substances in emergency drug kits shall be limited to a maximum of 8 maximum of 16 separate drug entities with not more than 8 single-use containers of each drug entity.
 
8. The pharmacist shall receive and file for 4 years 2 years a copy of all completed usage records.

Section 4 Question 4 Explanation Is Updated.

(10). New prescriptions conveyed by telephone shall not be accepted and the caller shall be instructed to call back or a telephone number obtained for the pharmacist to call upon his or her return;

Section 4 Question 9 Question And Explanation Are Changed.

The transfer of original prescription drug Schedule III to V controlled drugs prescription order information for the purpose of refill dispensing shall be communicated directly between:
 
Original prescription drug order information for drugs may be transferred between pharmacies for the purpose of refill dispensing subject to the following:
 
(a). The transfer shall be communicated directly between 2 licensed pharmacists;

(a) The transfer of controlled drug prescriptions shall be communicated between 2 licensed pharmacists;

(b) The transfer of non-controlled prescriptions shall be communicated between 2 licensed pharmacists, NH certified pharmacy technicians or pharmacy interns; and

(c) The transferring pharmacist, NH certified pharmacy technician or pharmacy intern shall notate in the computer record the following:



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August 9, 2016 Louisiana Pharmacy Law Updates/Corrections


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Section 5 Question 30 Explanation And Answer Are Updated.

I only All, [http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf].
 
3. PA (Physician assistants): Can prescribe (only) Schedule III to V controlled substances.

Can prescribe, administer and order Schedule II to V controlled substances to the extent delegated by the supervising physician.
 
5. OD (Optometrists): Can prescribe and administer Schedule III to V controlled substances.

Can prescribe and administer Schedule II to V controlled substances.



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August 8, 2016 Massachusetts Pharmacy Law Updates/Corrections


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Section 2 Question 9 Explanation Is Updated.

Each pharmacy shall submit the information in accordance with transmission methods and frequency requirements promulgated by the department; provided, however, that the information shall be submitted at least once every 7 days once every 24 hours.


Section 4 Question 18 Explanation and Answer Are Updated.

7 days 24 hours, [Massachusetts Controlled Substance Act Chapter 94C: Section 24A].
 
4. Each pharmacy shall submit the information in accordance with transmission methods and frequency requirements promulgated by the department; provided, however, that the information shall be submitted at least once every 7 days once every 24 hours.



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August 6, 2016 Tennessee Pharmacy Law Updates/Corrections


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Section 3 Question-8 Entire Question Regarding Pseudoephedrine Limit Is Updated.

Which of the following are TRUE about the Meth-Free Tennessee Act of 2005?
 
I. A pharmacy shall not sell to the same person more than three individual packages of any non-exempt product containing any immediate methamphetamine precursor.
 
II. A pharmacy shall not sell to the same person any combination of such products containing more than 9 grams of ephedrine, pseudoephedrine, or their salts, isomers, or salts of isomers, during the same 30-day period.
 
III. Products in the form of gel capsules and liquid preparations that contain any immediate methamphetamine precursor are exempted from Meth-Free Tennessee Act.
 
a. I only
b. I and II only
c. II and III only
d. All
 
All, [Meth-Free Tennessee Act of 2005, Public Acts 2005, Chapter No. 18].
 
1. A pharmacy shall not sell to the same person more than three individual packages of any non-exempt product containing any immediate methamphetamine precursor, nor shall a pharmacy sell to the same person any combination of such products containing more than 9 grams of ephedrine, pseudoephedrine, or their salts, isomers, or salts of isomers, during the same 30-day period.
 
2. The 9 gram limit shall apply to the total amount of base ephedrine and pseudoephedrine contained in the products, and not the overall weight of the products. The prohibition contained in this subsection shall not apply to a person who obtains the product or products pursuant to a valid prescription.
 
3. The pharmacist, or any pharmacy technician or pharmacy intern under the supervision of the pharmacist, shall require any person purchasing a non-exempt product that contains any immediate methamphetamine precursor to present valid government-issued identification at the point of sale.
 
4. The pharmacist, pharmacy technician or pharmacy intern shall maintain an electronic record of the sale. The record shall include
 
a. the name of purchaser,
b. name and quantity of product purchased,
c. date purchased,
d. purchaser identification type and number (such as driver license state and number), and
e. the identity (such as name, initials, or identification code) of the dispensing pharmacist, pharmacy technician or pharmacy intern.
 
5. A pharmacy choosing to maintain a written register must retain the register for at least one year.
 
6. Non-exempt products containing an immediate methamphetamine precursor shall be maintained behind the counter of the pharmacy or in a locked case within view of and within 25 feet of the counter.
 
Which of the following is/are TRUE about selling pseudoephedrine base OTC in Tennessee?
 
I. A pharmacy-intern may allow selling an over-the-counter product containing pseudoephedrine or ephedrine.
 
II. A pharmacy shall not sell products containing ephedrine or pseudoephedrine base, or their salts, isomers or salts of isomers to the same person in an amount more than 5.76 grams within 30-day period.
 
III. A pharmacy shall not sell products containing ephedrine or pseudoephedrine base, or their salts, isomers or salts of isomers to the same person in an amount more than 28.8 grams within 1-year period.
 
a. I only
b. I and II only
c. II and III only
d. All
 
All, [Title 39  Criminal Offenses Chapter 17  Offenses Against Public Health, Safety and Welfare Part 4  Drugs 39-17-431].
 
(c). (1) A pharmacy shall not sell products containing ephedrine or pseudoephedrine base, or their salts, isomers or salts of isomers to the same person in an amount more than:
 
(A). Five and seventy-six hundredths (5.76) grams in any period of thirty (30) consecutive days; or
 
(B). Twenty-eight and eight tenths (28.8) grams in any one-year period.
 
(2). A person shall not purchase products containing ephedrine or pseudoephedrine base, or their salts, isomers or salts of isomers in an amount more than:
 
(A). Five and seventy-six hundredths (5.76) grams in any period of thirty (30) consecutive days; or
 
(B). Twenty-eight and eight tenths (28.8) grams in any one-year period.
 
(3). The limits in this subsection (c) shall apply whether one (1) form of identification required in subsection (d) is used to make the purchase or if two (2) or more forms of identification required in subsection (d) are used to purchase the products.

The limits contained in this subsection (c) shall apply to the amount of ephedrine or pseudoephedrine base, or their salts, isomers, or salts of isomers contained in a product.

The prohibitions contained in this subsection (c) shall not apply to a person who obtains the product or products pursuant to a valid prescription issued by a licensed healthcare practitioner authorized to prescribe by the laws of the state.
 
(4). This subsection (c) also shall apply to pharmacist-generated prescription orders of the product pursuant to § 63-10-206. The provision of the patient education and counseling as a part of the practice of pharmacy shall be required when any product is issued under this subsection (c).
 
(5). There shall be no protocol or procedure mandated by any individual or corporate entity that interferes with the pharmacist's professional duty to counsel and evaluate the patient's appropriate pharmaceutical needs and the exercise of the pharmacist's professional judgment as to whether it is appropriate to dispense medication as set forth in subsection (d) or otherwise.
 
(d). The pharmacist or pharmacy intern under the supervision of the pharmacist shall require any person purchasing an over-the-counter product containing pseudoephedrine or ephedrine to present valid government issued photo identification at the point of sale.
 
The pharmacist or pharmacy intern shall counsel with the person seeking to purchase the product as to the reasons for needing the product and may decline the sale if the pharmacist or pharmacy intern believes the sale is not for a legitimate medical purpose.
 
The pharmacist, pharmacy technician, or pharmacy intern shall maintain an electronic record of the sale under this subsection (d) and the record may be maintained in the form of a pharmacist prescription order as provided by § 63-10-206(c).
 
The electronic record shall include the name and address of purchaser; name and quantity of product purchased; date and time purchased; purchaser identification type and number, such as driver license state and number; and the identity, such as name, initials or identification code, of the dispensing pharmacist or pharmacy intern.
 
If a system is not able to record the identification type and number, the pharmacist, pharmacy technician, or pharmacy intern shall write the identification type and number on the prescription order.

The electronic record shall also be maintained in a manner that allows for the determination of the equivalent number of packages purchased and total quantity of base ephedrine or pseudoephedrine purchased.


Section 3 Question-15 Entire Question Is Updated.

Which of the following is/are exempt from the Meth-Free Tennessee Act of 2005?
 
I. Ephedrine suspension
II. Pseudoephedrine gel capsules
III. Phenylpropanolamine capsules
 
a. I only
b. I and II only
c. II and III only
d. All
 
I and II only, [The Meth-Free Tennessee Act of 2005].
 
The Board of Pharmacy shall maintain a public list of such exempted products or categories of products. Any person may request that a product or category of products be included on the exemption list. Such a list shall include, but not be limited to, products in the form of gel capsules and liquid preparations that contain any immediate methamphetamine precursor.
 
The term "gel capsule" means any soft gelatin liquid-filled capsule that contains a liquid suspension, which, in the case of pseudoephedrine, is suspended in a matrix of glycerin, polyethylene glycol, and propylene glycol, along with other liquid substances. Regardless of the product manufacturer's labeling, a gelatin-covered solid does not constitute a "gel capsule" under this provision.
 
A pharmacy selling an over-the-counter product containing pseudoephedrine or ephedrine may seek an exemption from submitting transactions to the electronic sales tracking system in writing to the board of pharmacy stating the reasons therefore. The board of pharmacy may grant an exemption for good cause shown, but in no event shall such exemption exceed one hundred eighty (180) days.
 
True or False
 
True, [Title 39  Criminal Offenses Chapter 17  Offenses Against Public Health, Safety and Welfare  Part 4  Drugs Section 39-17-431].
 
(e). (1) By January 1, 2012, each pharmacy in this state shall have in place and operational all equipment necessary to access and use the National Precursor Log Exchange (NPLEx) administered by the National Association of Drug Diversion Investigators (NADDI). The NPLEx system shall be available for access and use free of charge to the pharmacies and this state.
 
(2). Beginning January 1, 2012, before completing a sale of an over-the-counter product containing pseudoephedrine or ephedrine not otherwise excluded from the record keeping requirement, a pharmacy shall electronically submit the required information to NPLEx administered by NADDI.
 
On learning of a data entry error in which a transaction was submitted to NPLEx when it should not have been, the pharmacy shall submit a data entry error correction to NPLEx to remedy the error and prevent an inappropriate stop sale alert from being generated for a person who may seek to purchase an over-the-counter product containing pseudoephedrine or ephedrine. Except as provided in subsection (j), the seller shall not complete the sale if the system generates a stop sale alert.
 
(3). Absent negligence, wantonness, recklessness, or deliberate misconduct, any pharmacy utilizing the electronic sales tracking system in accordance with this subsection (e) shall not be civilly liable as a result of any act or omission in carrying out the duties required by this subsection (e) and shall be immune from liability to any third party unless the retailer has violated this subsection (e) in relation to a claim brought for such violation. This subsection (e) shall not apply to a person who obtains the product or products pursuant to a valid prescription.
 
(4). The data entered into, stored and maintained by the NPLEx may only be used by law enforcement officials, healthcare professionals and pharmacists and only for controlling the sale of methamphetamine precursors.
 
(5). If, for any reason, the NPLEx administered by NADDI is no longer the system used in this state to track the sale of methamphetamine precursors, whether because the system no longer functions, is no longer in existence, is no longer offered to the state without cost, or is otherwise no longer available, each pharmacy shall switch to and commence using the Tennessee Methamphetamine Information System (TMIS), as soon as the equipment necessary to access and use the system is made available at no charge to the pharmacy. TMIS shall be available for access and use free of charge to the pharmacies.
 
(f). If a pharmacy selling an over-the-counter product containing pseudoephedrine or ephedrine experiences mechanical or electronic failure of the tracking system and is unable to comply with the electronic sales tracking requirement, the pharmacy or retail establishment shall maintain a written log until such time as the pharmacy or retail establishment is able to comply with the electronic sales tracking requirement.
 
(g). A pharmacy selling an over-the-counter product containing pseudoephedrine or ephedrine may seek an exemption from submitting transactions to the electronic sales tracking system in writing to the board of pharmacy stating the reasons therefore. The board of pharmacy may grant an exemption for good cause shown, but in no event shall such exemption exceed one hundred eighty (180) days.
 
Any pharmacy or retail establishment that receives an exemption shall maintain a hardcopy logbook and must still require the purchaser to provide the information required under this section before completion of any sale.

The logbook shall be maintained as a record of each sale for inspection by any law enforcement officer or inspector of the board of pharmacy during normal business hours.
 
(h). Nonexempt products containing an immediate methamphetamine precursor shall be maintained behind-the-counter of the pharmacy or in a locked case within view of and within twenty-five feet (25') of the counter.
 
(i). All data that is collected from Tennessee pharmacies and stored in the NPLEx will be downloaded and exported by electronic means to TMIS at least every twenty-four (24) hours.

This export of data will be in a version in compliance with the National Information Exchange Standard and agreed to by both the TBI and NADDI.
 
The export will be executed without a charge to TMIS or any agency of this state. Any and all data exported to, obtained by, gathered by, transmitted to and/or stored by TMIS or its designee, once received from NADDI, is the property of this state.
 
TMIS has the authority to control, administer, and disseminate, at its discretion, this transaction data for the purpose of enforcing federal and state laws. In addition to the exporting of data to TMIS, real time access to NPLEx information through the NPLEx online portal shall be provided to law enforcement in the state free of charge.
 
(j).  (1) NPLEx shall generate a stop sale alert, if completion of a sale would result in the seller or purchaser violating the quantity limits set forth in this section. The system shall contain an override function that may be used by a dispenser of ephedrine or pseudoephedrine who has a reasonable fear of imminent bodily harm if the sale is not completed. Each instance in which the override function is utilized shall be logged by the system.
 
(2). In instances when a data entry correction has been submitted to the NPLEx concerning a purchaser in accord with subdivision (e)(2), the NPLEx shall not generate a stop sale alert in cases where the quantity limit is exceeded due to the data entry error for which the correction was submitted.
 
(k). A violation of subsections (a)-(j) is a Class A misdemeanor, punishable by fine only. If the person in violation is a licensed pharmacy or pharmacist, the violation shall be reported to the board of pharmacy for review and appropriate action. If a product is dispensed in violation of subsection (a), the owner or operator of the wholesale or retail establishment dispensing the product shall be in violation of subsection (a).



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August 4, 2016 Hawaii Pharmacy Law Updates/Corrections


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Section 2 Question 25 Answer Explanation Is Updated.

(a). A pharmacist may administer the influenza vaccine a vaccine to persons between fourteen and seventeen years of age pursuant to a valid prescription. The pharmacist shall verify that the prescriber or the prescriber's authorized agent is the patient's medical home.



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August 3, 2016 Arizona Pharmacy Law Updates/Corrections


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Section 2 Question 17 Question, Explanation And Answers Are Updated.

The Board Office (Arizona) shall finish an administrative completeness review of permit application (for pharmacy) within 20 days from the date of receipt of an application packet.
 
True, [Arizona Administrative Code R4-23-602(C)(D)(E)].
 
1. The Board Office (Arizona) shall finish an administrative completeness review of permit application (for pharmacy) within 20 days from the date of receipt of an application packet. However, if the application packet is incomplete, the Board Office shall provide the applicant with a written notice that includes a comprehensive list of the missing information.
 
2. The 20-day time-frame for the Board Office to finish the administrative completeness review is suspended from the date the notice of incompleteness is served until the applicant provides the Board Office with all missing information.
 
An applicant with an incomplete application packet shall submit to the Board Office all of the missing information within 60 days of service of the notice of incompleteness.
 
3. If an applicant cannot submit all missing information within 60 days of service of the notice of incompleteness, the applicant may obtain an extension by submitting a written request to the Board Office postmarked or delivered within 60 days of service of the notice of incompleteness.
 
The written request for an extension shall document the reasons the applicant is unable to meet the 60-day deadline.
 
4. The Board Office shall review the request for an extension of the 60-day deadline and grant the request if the Board Office determines that an extension of the 60-day deadline will enable the applicant to assemble and submit the missing information.
 
An extension of the 60-day deadline shall be for no more than 60 days. An applicant that requires an additional extension shall submit an additional written request in accordance with this subsection. The Board Office shall notify the applicant in writing of its decision to grant or deny the request for an extension.
 
5. If an applicant fails to submit a complete application packet within the time allowed, the Board Office shall close the applicant's file. An applicant whose file has been closed and who later wishes to obtain a permit shall apply again in accordance with law.
 
The Board Office (Arizona) shall finish an administrative completeness review of permit application (for pharmacy) within 60 days from the date of receipt of an application packet.
 
True, [Arizona Administrative Code R4-23-602(C)(D)(E)].
 
1. The Board office shall finish an administrative completeness review within 60 days from the date the application form is received.
 
a. The Board office shall issue a written notice of administrative completeness to the applicant if no deficiencies are found in the application form.
 
b. If the application form is incomplete, the Board office shall provide the applicant with a written notice that includes a comprehensive list of the missing information. The 60-day time-frame for the Board office to finish the administrative completeness review is suspended from the date the notice of incompleteness is served until the applicant provides the Board office with all missing information.
 
c. If the Board office does not provide the applicant with written notice regarding administrative completeness, the application form shall be deemed complete 60 days after receipt by the Board office.
 
2. An applicant with an incomplete application form shall submit to the Board office all of the missing information within 90 days of service of the notice of incompleteness.
 
a .If an applicant cannot submit all missing information within 90 days of service of the notice of incompleteness, the applicant may send a written request for an extension to the Board office postmarked or delivered no later than 90 days from service of the notice of incompleteness;
 
b. The written request for an extension shall document the reasons the applicant is unable to meet the 90-day deadline; and
 
c. The Board Office office shall review the request for an extension of the 90-day deadline and grant the request if the Board Office office determines that an extension of the 90-day deadline will enable the applicant to assemble and submit the missing information. An extension shall be for no more than 30 days. The Board office shall notify the applicant in writing of its decision to grant or deny the request for an extension.
 
3. If an applicant fails to submit a complete application form within the time allowed, the Board office shall close the applicant's file. An applicant whose file is closed and who later wishes to obtain a permit shall submit a new application and fee as specified in subsection (A).
 
4. For a nonprescription drug permit applicant, a compressed medical gas distributor permit applicant, and a durable medical equipment and compressed medical gas supplier permit applicant, the Board office shall issue a permit on the day that the Board office determines an administratively complete application form is received.
 
5. Except as described in subsection (C)(4), from the date on which the administrative completeness review of an application form is finished, the Board office shall complete a substantive review of the applicant's qualifications in no more than 120 days.


Section 2 Question 25 Explanation Is Updated.

To obtain a permit to operate a new pharmacy or change ownership, relocate, or remodel an existing pharmacy in Arizona, a person shall submit a completed application, on a form furnished by the Board, that includes:
 
a. The type of pharmacy;
 
b. Business name, address, mailing address, if different, telephone number, and facsimile number;
 
c. Owner's name, if corporation or partnership, officers or partners, including address and title, and any other trade or business names used;
 
1. To obtain a permit to operate a pharmacy in Arizona, a person shall submit a completed application form and fee as specified in R4-23-602 that includes:
 
a. Documentation of compliance with local zoning laws, if required by the Board;
 
b. A detailed floor plan showing proposed pharmacy area including size and security;
 
c. A copy of the lease agreement, if applicable; and;
 
d. A disclosure statement indicating whether a medical practitioner will receive compensation, either directly or indirectly, from the pharmacy;
 
2. Before issuing a pharmacy permit, the Board shall:
 
a. Receive and approve a completed permit application; and
 
b. Receive a satisfactory compliance inspection report on the facility from a Board compliance officer.
 
3. Before issuing a pharmacy permit, the Board may interview the applicant and the pharmacist-in-charge, if different from the applicant, at a Board meeting based on the need for additional information.
 
C. Notification. A pharmacy permittee shall notify the Board office within ten days of changes involving the type of pharmacy operated, telephone number, facsimile number, e-mail address, mailing address, name of business, or staff pharmacist. A pharmacy permittee shall provide the Board of immediate notice of a change of the pharmacist-in-charge.
 
D. If any nonprescription drugs are sold outside the pharmacy area when the pharmacy area is closed, the pharmacy permittee shall ensure that the business has a current, Board-issued nonprescription drug permit as required in Section R4-23-603.
 
E. Change of ownership. No less than 14 days before a change of ownership occurs that involves changes of stock ownership of 30% or more of the voting stock of a corporation or an existing and continuing corporation that is not actively traded on any securities market or over-the-counter market, the prospective owner shall submit a completed application form and fee as specified in subsection (B).


Section 2 Question 30 Question And Explanation Are Updated.

Which of the following is/are TRUE regarding administration of vaccines to patients by pharmacists?
 
I. The pharmacist may administer immunizations and, in an emergency, epinephrine and diphenhydramine to an eligible patient 18 years of age and older upon receipt of a valid prescription order.
 
I.  A pharmacist or a pharmacy or graduate intern, in the presence of and under the immediate personal supervision of a certified pharmacist, may administer, without a prescription, immunizations or vaccines and, in an emergency, epinephrine and diphenhydramine to an eligible adult patient or eligible minor patient.
 
(A). The pharmacist or pharmacy or graduate intern under the immediate personal supervision of a certified pharmacist may administer immunizations and, in an emergency, epinephrine and diphenhydramine to an eligible patient 18 years of age and older upon receipt of a valid prescription order.
 
(A). A pharmacist or a pharmacy or graduate intern, in the presence of and under the immediate personal supervision of a certified pharmacist, may administer, without a prescription, immunizations or vaccines and, in an emergency, epinephrine and diphenhydramine to an eligible adult patient or eligible minor patient.


Section 3 Question 26 Answer Explanation Is Updated.

iii. The provider pharmacy's personnel restock the emergency drug supply unit within 48 hours of receiving the notification.
 
Exchange or restock the emergency drug supply unit weekly, or more often as necessary, to ensure the availability of an adequate supply of emergency drugs within the long-term care facility. Restocking of the emergency drug supply unit at the facility shall be completed by an Arizona licensed pharmacist employed by the provider pharmacy, or by an Arizona licensed intern, technician or technician trainee under the direct on-site supervision of an Arizona licensed pharmacist.


Section 4 Question 1 Entire Question Is Updated With New Question.

The pharmacist-in-charge of an emergency drug provider pharmacy shall ensure that:
 
I.  An emergency drug supply unit is available within the long-term care facility.
 
II.  Drugs contained in an emergency drug supply unit remain the property of the provider pharmacy.
 
III.  Controlled substance drugs contained in an emergency drug supply unit are included in all inventories.
 
a. I only
b. I and II only
c. II and III only
d. All
 
Answer: All, [Arizona Administrative Code R4-23-701.02(A)].
 
A. The limited-service pharmacy permittee or pharmacist-in-charge of a provider pharmacy shall ensure that:
 
1. An emergency drug supply unit is available within the long-term care facility,
 
2. Drugs contained in an emergency drug supply unit remain the property of the provider pharmacy, and
 
3. Controlled substance drugs contained in an emergency drug supply unit are included in all inventories required under A.R.S. § 36-2523(B) and R4-23-1003(A).  


Section 4 Question 3 Answer Explanation Is Updated.

A. A prescription-only drug shall be dispensed only under one of the following conditions:
 
1. By a medical practitioner in conformance with section 32-1921.
 
2. On a written prescription order bearing the prescribing medical practitioner's manual signature.
 
3. On an electronically transmitted prescription order containing the prescribing medical practitioner's electronic or digital signature that is reduced promptly to writing and filed by the pharmacist.
 
4. On a written prescription order generated from electronic media containing the prescribing medical practitioner's electronic or manual signature. A prescription order that contains only an electronic signature must be applied to paper that uses security features that will ensure the prescription order is not subject to any form of copying or alteration.
 
5. On an oral prescription order that is reduced promptly to writing and filed by the pharmacist.
 
6. By refilling any written, electronically transmitted or oral prescription order if a refill is authorized by the prescriber either in the original prescription order, by an electronically transmitted refill order that is documented promptly and filed by the pharmacist or by an oral refill or
 
7. On a prescription order that the prescribing medical practitioner or the prescribing medical practitioner's agent transmits by fax or electronic mail.
 
8. On a prescription order that the patient transmits by fax or by email if the patient presents a written prescription order bearing the prescribing medical practitioner's manual signature when the prescription-only drug is picked up at the pharmacy.


Section 4 Question 18 Answer And Explanation Are Updated.

False True [http://www.nabp.net/publications/assets/AZ072010.pdf]. 

Optometrists in Arizona holding a Pharmaceutical Agent (PA) certificate are authorized to prescribe, administer, or dispense topical diagnostic, topical therapeutic, and oral pharmaceutical agents or a Schedule III (NOT a schedule II) Schedule III and Schedule II Hydrocodone containing controlled substances used for examination, diagnosis, or treatment of conditions of the human eye and its adnexa.

Section 5 Question 30 Answer Explanation and Answer Are Updated.

I and II only, All [http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf].

6. OD (Optometrists): Schedule III controlled substances.

6. OD (Optometrists): Schedule III To V controlled substances and Schedule II Hydrocodone products only.



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July 20, 2016 North Carolina Pharmacy Law Updates/Corrections


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Section 1 Question 20 Answer Explanation Is Changed.

A pharmacist-manager must notify the Board within 30 days (NOT 60 days) of the date the pharmacy technician began employment.
 
A pharmacist-manager must notify the Board within 21 days (NOT 60 days) of the date the pharmacy technician began employment.
 
A pharmacist-manager may hire a certified pharmacy technician who has registered with the Board.  The certified pharmacy technician shall notify the Board within 10 days of beginning employment as a pharmacy technician.


Section 1 Question 30 Explanation Is Updated.

The pharmacist-manager shall develop written policies and procedures that:
 
(1). permit a Validating Technician to validate only the following functions of other registered pharmacy technicians in filling floor stock and unit dose distribution systems for inpatients in a Hospital:
 
(A). stocking of patient care unit medication inventories;
 
(B). stocking of ancillary drug cabinet inventories;
 
(C). stocking of automated dispensing or drug supply devices;
 
(D). stocking of emergency kits; and
 
(E). prepackaging of prescription drugs within the Hospital pharmacy;


Section 3 Question 6 Is Replaced With New Question.

How often shall the NADDI forward North Carolina transaction records in NPLEx to the State Bureau of Investigation?
 
a. Daily
b. Weekly
c. Monthly
d. Quarterly
 
Answer: Weekly, [NC  90-113.52A(a), (c)].
 
A retailer shall, before completing a sale of a product containing a pseudoephedrine product, electronically submit the required information to the National Precursor Log Exchange (NPLEx) administered by the National Association of Drug Diversion Investigators (NADDI), provided that the NPLEx system is available to retailers in the State without a charge for accessing the system and the retailer has Internet access.
 
The seller shall not complete the sale if the system generates a stop alert.
 
If a pharmacy selling a product containing a pseudoephedrine product experiences mechanical or electronic failure of the electronic sales tracking system and is unable to comply with the electronic sales tracking requirement, the pharmacy or retail establishment shall record that the sale was made without submission to the NPLEx system in the record of disposition required under G.S. 90-113.52.
 
The NADDI shall forward North Carolina transaction records in NPLEx to the State Bureau of Investigation weekly and provide real-time access to NPLEx information through the NPLEx online portal to law enforcement in the State as authorized by the SBI, provided that the SBI executes a memorandum of understanding with NADDI governing access.


Section 3 Question 18 Is Replaced With A New Question.

Each CPP shall register annually on or before:
 
a. March 31
b. December 31
c. July 31
d. June 30
 
Answer: December 31, [21 NCAC 46 .3101(c)].
 
Each CPP shall register annually on or before December 31 by:
 
(A). verifying that the CPP holds a current Pharmacist license;
 
(B). submitting the renewal fee as specified in Subparagraph (j)(2) of this Rule;
 
(C). completing the Pharmacy Board's renewal form; and
 
(D). reporting continuing education credits as required by Paragraph (d) of this Rule.
 
(2). If the CPP has not renewed the CPP's annual registration pursuant to Subparagraph (c)(1) of this Rule within 60 days of December 31, the approval to practice as a CPP shall lapse.


Section 4 Question 2 Is Replaced With A New Question.

Schedule II controlled drugs are expired after 30 days from their issued date.
 
Answer: False, [http://www.ncbop.org/about/Student%20Projects/CSpocketcardRevNov2013.pdf].
 
North Carolina state law (that went into effect on October 1, 2013) provides that “No Schedule II substance shall be dispensed pursuant to a written prescription more than six months after the date it was prescribed.” The new six-month limitation applies to all prescriptions issued on or after October 1, 2013.


Section 4 Question 13 Is Replaced With A New Question.

Immediately prior to dispensing a Schedule II controlled substance, each pharmacy holding a valid permit shall require the person seeking the dispensation to present one of the following valid, unexpired forms of government-issued photographic identification. These may include:
 
I. a driver’s license
II. a military identification card
III.  a special identification card issued under G.S. 20-37.7
 
a. I only
b. I and II only
c. II and III only
d. All
Answer: All, [NC Controlled Substances Act 90-106.1].
 
(a). Immediately prior to dispensing a Schedule II controlled substance, or any of the Schedule III controlled substances listed in subdivisions 1. through 8. of G.S. 90-91(d), each pharmacy holding a valid permit pursuant to G.S. 90-85.21 shall require the person seeking the dispensation to present one of the following valid, unexpired forms of government-issued photographic identification:
 
(i). a driver’s license,
 
(ii). a special identification card issued under G.S. 20-37.7,
 
(iii). a military identification card, or
 
(iv). a passport.
 
Upon presentation of the required photographic identification, the pharmacy shall document the name of the person seeking the dispensation, the type of photographic identification presented by the person seeking the dispensation, and the photographic identification number.
 
The pharmacy shall retain this identifying information on the premises or at a central location apart from the premises as part of its business records for a period of three years following dispensation.
 
(b). The pharmacy shall make the identifying information available to any person authorized under G.S. 90-113.74 to receive prescription information data in the controlled substances reporting system within 72 hours after a request for the identifying information. A pharmacy that submits the identifying information required under this section to the controlled substances reporting system established and maintained pursuant to G.S. 90-113.73 is deemed in compliance with this subsection.


Section 4 Question 16 Explanation IS Updated.

For the State of North Carolina, only following mid-level practitioners can either prescribe or administer or both, schedule controlled substances.
 
1. AS (Animal Shelters): Can prescribe Schedule II to III controlled substances.
 
2. NP (Nurse Practitioner): Can prescribe and/or administer but CANNOT ORDER Schedule II to V controlled substances.
 
3. PA (Physician assistants): Can prescribe ONLY Schedule II to V controlled substances. Also, 30-day supply restriction when prescribing schedule II and III controlled substances.
 
4. AMB (Ambulance Service): Can prescribe Schedule II to V controlled substances (Line 2 requires physician's name)
 
5. NH (Nursing Homes): Can prescribe Schedule II to V controlled substances.
 
6. OD (Optometrists): Can prescribe Schedule II to V controlled substances.
 
7. RPH (Registered Pharmacists): Can prescribe, procure and dispense Schedule II to V controlled substances.
 
For the State of North Carolina, only following mid-level practitioners can either prescribe or administer or both, schedule controlled substances.
 
1. AS (Animal Shelters): Can administer and procure Schedule II to III controlled substances.
 
2. NP (Nurse Practitioner): Can prescribe, dispense and procure Schedule II to V controlled substances. Also, 30-day supply restriction when prescribing schedule II and III controlled substances.
 
3. PA (Physician assistants): Can prescribe Schedule II to V controlled substances. Also, 30-day supply restriction when prescribing schedule II and III controlled substances.
 
4. AMB (Ambulance Service): Can administer, dispense or procure Schedule II to V controlled substances (Line 2 requires physician's name)
 
5. NH (Nursing Homes): Can administer, dispense or procure Schedule II to V controlled substances.
 
6. OD (Optometrists): Can prescribe, administer and dispense Schedule II to V controlled substances.
 
7. RPH (Registered Pharmacists): Can prescribe Schedule II to V controlled substances.


Section 5 Question 1 Explanation IS Updated.

Added Following:
 
(6). Opioid antagonists prescribed pursuant to G.S. 90-106.2; and
 
(7). Epinephrine auto-injectors prescribed pursuant to G.S. 115C-375.2A



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July 15, 2016 South Carolina Pharmacy Law Updates/Corrections


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Section 3 Question 13 Question, Explanation And Answer Are Changed.

II. The transferring pharmacist shall reduce any remaining refills by one and so mark the face of the prescription retained by the transferring pharmacist or record information electronically.
 
III. The pharmacist receiving the transferred prescription shall dispense only one refill. The transferring pharmacist shall retain the original prescription and shall continue to dispense refills up to the amount for the period authorized less one refill allocated to the receiving pharmacist.

II. The transferring pharmacist shall void any remaining refills and so mark the face of the prescription retained by the transferring pharmacist or record information electronically.
 
III. The transferring pharmacist shall record the name and address of the pharmacy to which the prescription was transferred and the name of the pharmacist receiving the prescription information on the reverse side of the transferred prescription or record information electronically.

All, [South Carolina Pharmacy Practice Act, SECTION 40-43-86(G)].

The one-time transfer of original prescription information for the purpose of dispensing one refill is permissible between pharmacies in this State subject to these requirements:

(I). The transfer must be communicated directly between two pharmacists.

(II). The transferring pharmacist shall reduce any remaining refills by one and so mark the face of the prescription retained by the transferring pharmacist or record information electronically.

(III). The transferring pharmacist shall record the name and address of the pharmacy to which the prescription was transferred and the name of the pharmacist receiving the prescription information on the reverse side of the transferred prescription or record information electronically.

(IV). The pharmacist receiving the transferred prescription shall dispense only one refill.

The transferring pharmacist shall retain the original prescription and shall continue to dispense refills up to the amount for the period authorized less one refill allocated to the receiving pharmacist.

(V). Both the original and transferred prescription drug order must be maintained for a period of two years from the date of last refill.





All, [South Carolina Pharmacy Practice Act, SECTION 40-43-86(G)].
 
The transfer of original prescription information for the purpose of dispensing refills is permissible between licensed or permitted pharmacies subject to these requirements:
 
(a). The transfer must be communicated directly between two pharmacists and not by one pharmacist accessing an information file containing data for several locations, unless all locations accessed are under common ownership or accessed pursuant to contractual agreement of the pharmacies.
 
(b). The transferring pharmacist shall void any remaining refills and so mark the face of the prescription retained by the transferring pharmacist or record information electronically.
 
(c). The transferring pharmacist shall record the name and address of the pharmacy to which the prescription was transferred and the name of the pharmacist receiving the prescription information on the reverse side of the transferred prescription or record information electronically.
 
(2). The transferring pharmacist shall record in writing the date of the transfer and the name of the pharmacist transferring the information or record information electronically.
 
(3). Both the original and transferred prescription drug order must be maintained for a period of two years from the date of last refill.


Section 3 Question 25 Answer Choice Is Updated.

a. Vicodin

a. Ambien

Section 2 Question 13 Explanation Is Updated.

The Board of Medical Examiners shall issue a written protocol for the administration of influenza vaccines by pharmacists without an order of a practitioner. The administration of influenza vaccines as authorized in this section must not be to persons under the age of 18 years (Not 16 years).

The administration of vaccines as authorized in this section must not be to a person under the age of eighteen years; provided, however, that:
 
(a) the influenza vaccine may be administered to a person twelve years of age or older pursuant to protocol issued by the Board of Medical Examiners; and
 
(b) a pharmacist who has completed the training described in subsection (B)(1) may administer a vaccine approved by the Centers for Disease Control to a person of any age pursuant to a written order or prescription of a practitioner for a specific patient of that practitioner.

All records required by this section must be maintained in the pharmacy for a period of at least six years.

All records required by this section must be maintained in the pharmacy for a period of at least ten years from the date of the last vaccination for adults and at least thirteen years from the date of the last vaccination for minors.
 
A pharmacy intern may administer vaccinations under the direct supervision, of a pharmacist who has completed vaccination training as required by law if the pharmacy intern:
 
(a). is certified through a basic life support or CPR provider-level course that is jointly approved by the Board of Medical Examiners and the Board of Pharmacy; and
 
(b). completes the course of training described in law.



Section 5 Question 30 Answer and Explanations Are Updated.

I only. I and II only.  

OD (Optometrists):  Schedule III to V controlled substances.

OD (Optometrists):  Schedule III to V controlled substances. Schedule II Hydrocodone containing products only.



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July 11, 2016 New Jersey Pharmacy Law Updates/Corrections


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Section 2 Question 19 Question, Question, Answer and Explanation Are Changed.

After dispensing an emergency Schedule II drug, the pharmacist has to contact which of the following upon not receiving a written prescription from the prescriber within 3 7 days?
 
I. The DEA Office
II. The Drug Control Unit
III. The State Board of Pharmacy
 
a. I only
b. I and II only
c. II and III only
d. All
 
I and II only, [New Jersey Controlled Dangerous Substances Act 13:45H-7.8(d)(1-to-4).
 
Within 72 hours 7 days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed (not to exceed the amount for a 72 hour period) to be delivered to the dispensing pharmacist.
 
In addition to conforming to the requirements of N.J.A.C. 13:45H-7.4, the prescription shall have written on its face “Authorization for Emergency Dispensing," and the date of the oral order.
 
The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the 72 hours 7 days.
 
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 Drug Control Unit and the nearest office of the DEA in his district if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense with a written prescription of a prescribing individual practitioner.


Section 2 Question 21 Question, Explanation Is Changed.

True, [New Jersey Pharmacy Administrative Code 13:39-4.7(a)].
 
a). When a pharmacy permit holder intends to change the physical location and address of the permitted premises, the permit holder shall apply to the Board, at least 30 days prior to such change, for a new pharmacy permit. If the change in location and address will result in the temporary closing of the pharmacy, the permit holder shall comply with all requirements set forth at N.J.A.C. 13:39-4.10(c) and (d).
 
The permit holder shall submit a new permit application pursuant to N.J.A.C. 13:39-4.1 and the new permit application fee set forth in N.J.A.C. 13:39-1.3.
 
The Board shall issue an amended pharmacy permit reflecting the new location and address of the pharmacy. Before an amended permit may be issued to the permit holder for the new location, the Board shall inspect and approve the premises, fixtures, equipment and inventory of the new location to ensure compliance with this subchapter and all relevant statutes, regulations and ordinances.
 
The permit holder shall ensure that the prescription and profile records from the pharmacy's previous location and address are maintained pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the location and address change.
 
b). Whenever there is a change in a pharmacy's address but no change in the physical location of the licensed premises, the permit holder shall, within 10 business days of the change in address, submit an affidavit to the Board explaining such change.


Section 3 Question 4 Answer and Explanation Are Changed.

I and II only All, [New Jersey Controlled Dangerous Substances Act 13:45H-7.8(d)(1)(2)(3)].
 
The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period not to exceed 72 hours.
 
The prescription shall be immediately reduced to writing by the attending pharmacist and contained all the information required by the law.
 
The authorized prescriber shall deliver the written prescription for the emergency quantity prescribed to the dispensing pharmacy within  3 days (72 hours) 7 days after authorizing an emergency oral prescription.


Section 4 Question 29 Answer and Explanation Are Changed.

False True, [New Jersey Controlled Dangerous Substances Act 13:45H-7.14(e)(3)]. The hard-copy printout of each day’s controlled substance prescription order refill data shall be verified, dated, and signed by the individual pharmacist who refilled such a prescription order.
 
The individual pharmacist must verify that the data indicated is correct and then sign this document in the same manner as he would sign a check or legal document (e.g., J.H. Smith, or John H. Smith).
 
This document shall be maintained at that pharmacy for a period of two years five years from the dispensing date. This printout of the day’s controlled substance prescription order refill data must be provided to each pharmacy using such a computerized system within 48 hours 72 hours of the date on which the refill was dispensed.
 
It must be verified and signed by each pharmacist who is involved with such dispensing.
 
In lieu of such a printout, the pharmacy shall maintain a bound log book, or separate file, in which each individual pharmacist involved in such dispensing shall sign a statement (in the manner previously described) each day, attesting to the fact that the refill information entered into the computer that day has been reviewed by him and is correct as shown.
 
Such a book or file must be maintained at the pharmacy employing such a system for a period of two years five years after the date of dispensing the appropriately authorized refill.


Section 5 Question 15 Answer and Explanation Are Changed.

False, [New Jersey Controlled Dangerous Substances Act 13:45H-8.7(a,b)].
 
A registrant shall notify the Drug Control Unit in writing no less than 14 days (NOT 15 days) prior to the discontinuance or transfer of business activities with respect to controlled substances as set forth in (a) above, unless the Drug Control Unit waives this time limitation in individual instances, and shall return for cancellation to the Drug Control Unit, within 10 days of the discontinuance or transfer of business activities, the State Certification of Registration.
 
Such notification shall include but not be limited to:
 
1). Name, address, State CDS and Federal DEA registration numbers of the registrant discontinuing or transferring his controlled substances activities;
 
2). Name, address, State CDS and Federal DEA registration numbers of the registrant, or proof of application for same, of registrant to whom the controlled substances are to be transferred;
 
3). Name, address, State CDS and Federal DEA registration numbers, or proof of application for same of the registrant receiving the records, which include prescription files, or patient orders of practitioners of the discontinued business;
 
4). Name, and address of the person or firm who will maintain records, such as invoices, purchase records and executed order forms of the discontinued or transferred business for a period of not less than two years; and
 
5). The date on which the discontinuance or transfer of the business activity will take place.


Section 5 Question 11 Question and Explanation Are Changed.

What changes may a pharmacist make to a prescription written for a controlled substance in schedule II after verbally consulting with a practitioner?
 
I. Patient’s name
II. Controlled substance prescribed
III. Prescriber’s signature
 
None of the above, [http://njpublicsafety.com/ca/pharm/Board%20of%20Pharmacy%20Schedule%20II%20Guidance.pdf].
 
The Board has received many inquiries from pharmacists asking what types of changes, if any, can be made to hardcopy prescriptions written for Schedule II medications. The Board has compiled the below list of changes, with appropriate protocols to be followed, in order to provide direction for pharmacists when confronted with the following scenarios.
 
It should be noted that this document has been reviewed and approved, to be released as guidance, by the New Jersey Board of Pharmacy, the New Jersey Drug Control Unit, and the Director’s office of the Division of Consumer Affairs. The Drug Enforcement Administration has had an opportunity to review this Guidance Document, however the Board has not received any formal comment from that agency.
 
1). The following items may be changed upon consultation with the prescriber:
 
a. Patient’s address
b. Drug strength
c. Drug quantity (both numeric and alpha representations)
d. Drug dosage form
e. Directions for use
f. Date issued
g. DEA number (if omitted)
 
2). The following items may be added without consultation with the prescriber:
a. Patient’s address
b. Date of birth
c. A notation to correct a misspelled name
 
3). The following items are NEVER permitted to be changed:
 
a. Patient’s name (other than as noted above)
b. Controlled substance prescribed (except to substitute a generic)
c. Prescriber’s signature


Section 5 Question 30 Answer and Explanation Are Changed.

All, [http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf].
 
OD (Optometrists): Can prescribe (only) Schedule III to V controlled substances and Schedule II Hydrocodone products.



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July 10, 2016 Arkansas Pharmacy Law Updates/Corrections


  View Updates/Corrections

Section 1 Question 2 Explanation Is Updated.

The data processing system shall have the capacity to produce a daily hard-copy printout of all original prescriptions dispensed and refilled. The daily hard-copy printout shall be produced within 72 hours of the date on which the prescription drug orders were dispensed and shall be maintained in a separate file at the pharmacy.

Section 2 Question 22 Explanation Is Updated.

(A). The number of pharmacy technicians utilized in a hospital pharmacy or ambulatory care facility shall not exceed a ratio of two pharmacy technicians a ratio of three pharmacy technicians to each pharmacist on duty.


Section 4 Question 16 Answer and Explanation Are Changed.

All, [http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf].
 
1. AS (Animal Shelters): Can prescribe schedule II and III controlled substances.
 
2. PA (Physician Assistants): Can prescribe, order and administer Schedule III to V controlled substances AND schedule II hydrocodone containing products.
 
3. OD (Optometrists): Can prescribe Schedule III to V controlled substances AND schedule II hydrocodone containing products.
 
4. NP (Nurse Practitioners): Can prescribe, order and administer Schedule III to V controlled substances AND schedule II hydrocodone containing products.


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