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July 10, 2016 Minnesota Pharmacy Law Updates/Corrections


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Section1 Question 10 - Questions And Answers Are Updated.

In Minnesota, the inventory of controlled substances should be done every:

a. Year
b. Two years
c. Three years
d. Four years
 
Answer: Year, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4400 Subpart 3 and Sec.6800.4600].
 
In Minnesota, the inventory of controlled substances should be done annually. Also, each pharmacy located in this state shall maintain a perpetual inventory system for Schedule II controlled substances.
 
The system shall be established in a manner that will provide total accountability in all aspects of Schedule II drug distribution.
 
The inventory shall be reconciled with the actual inventory monthly and the reconciliations shall be documented. Reconciliation documentation shall be retained for at least two years.



Which of the following information regarding Schedule II controlled substances inventory in Minnesota is/are TRUE?
 
I. Each pharmacy located in this state shall maintain a perpetual inventory system for Schedule II controlled substances.
 
II. The system shall be established in a manner that will provide total accountability in all aspects of Schedule II drug distribution.
 
III. The inventory shall be reconciled with the actual inventory monthly and the reconciliations shall be documented.
a. I only
b. I and II only
c. II and III only
d. All
 
All, [Minnesota Administrative Rules Chapter 6800 Sec.6800.4400 Subpart 3 and Sec.6800.4600].
 
Each pharmacy located in this state shall maintain a perpetual inventory system for Schedule II controlled substances.
 
The system shall be established in a manner that will provide total accountability in all aspects of Schedule II drug distribution.
 
The inventory shall be reconciled with the actual inventory monthly and the reconciliations shall be documented.
 
Reconciliation documentation shall be retained for at least two years.
 
Additionally,
 
A person who engages in research, teaching, or educational projects involving the use, study, or testing of controlled substances shall annually, on or before June 1 of each year, apply for registration by the board. An inventory must be done annually (only by Registration Of Controlled Substance Researchers) to document control of each stocked controlled substance.




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June 30, 2016 North Carolina and Texas Sign Legislation to Make Naloxone More Accessible to Patients


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New legislation in North Carolina and Texas make naloxone, the opioid overdose reversal drug, more accessible to patients. North Carolina Governor Pat McCrory signed Senate Bill (SB) 734 into law on June 20, 2016, which authorizes the state health director to prescribe an opioid antagonist using a statewide standing order.

Under the former law, only a practitioner was authorized to prescribe an opioid antagonist pursuant to a standing order. SB 734 became effective the same day, according to the North Carolina Health and Human Services press release.
 
Beginning August 1, 2016, pharmacists in Texas will be authorized to dispense naloxone to patients under a standing order. The legislation will require pharmacists to complete a one-hour course accredited by the Accreditation Council for Pharmacy Education and in coordination with the Texas Pharmacy Association, according to a press release.

SB 1462 states an authorized prescriber may prescribe an opioid antagonist through a standing order. Medical doctors have unlimited, independent prescribing authority in every state. NABP’s 2016 Survey of Pharmacy Law states that pharmacists in Texas may perform specific acts relating to drug therapy management under written protocol from a practitioner including implementing or modifying therapy.


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June 23, 2016 Tennessee Pharmacy Law Updates/Corrections


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Section 1 Question 1 Question, Answer and Explanation Are Changed.

When an institutional pharmacy practice site is closed, access to prescription drugs shall be by locked cabinet(s), automated dispensing machines or other enclosure(s) constructed and located outside of the pharmacy practice site, to which only personnel authorized by the pharmacist in charge may obtain access.

The pharmacist in charge shall develop an inventory listing of those drugs to be included in such after hours storage, and shall ensure that such prescription drugs are prepackaged in amounts not to exceed a 7-day supply; unless available in a commercially prepared package dictating multiple dose therapy (e.g., ophthalmic products, topical products, otic products).

True or False

Answer: False, [Tennessee Pharmacy Practice Act of 1996 1140-4-.14(1)(b)].

When an institutional pharmacy practice site is closed, access to prescription drugs shall be by locked cabinet(s), automated dispensing machines or other enclosure(s) constructed and located outside of the pharmacy practice site, to which only personnel authorized by the pharmacist in charge may obtain access.

Access should be sufficiently secured to deny entry to unauthorized persons by force or otherwise. Those practice sites utilizing automated dispensing devices for after hours drug provision shall meet the requirements of rule 1140-4-.15. The pharmacist in charge shall develop an inventory listing of those drugs to be included in such after hours storage, and shall ensure that:

1. such prescription drugs are available therein, properly labeled;

2. such prescription drugs are prepackaged in amounts not to exceed a seventy-two (72) hour medication period; unless available in a commercially prepared package dictating multiple dose therapy (e.g., ophthalmic products, topical products, otic products);

3. all prescription drugs therein are inventoried at least once a month;

4. a record shall be made at the after hours storage location including the following elements:

(i) the date and time of removal of a drug;

(ii) the patient’s name and location;

(iii) the name, strength, dosage form, and quantity of the prescription drug; and

(iv) the identification of the authorized personnel removing the drug.

5. the prescription order shall be verified by a pharmacist or designee in a timely manner.

6. the above record shall be used by authorized pharmacy personnel to replenish the after hours storage location, and this record shall be kept at the institutional pharmacy practice site so as to be readily retrievable for at least two (2) years;

7. policies and procedures shall be established to implement the requirements of this section.

Section 1 Question 21 Explanation Is Changed.

(a). The pharmacy technician to pharmacist ratio shall not exceed 2:1; however the ratio may be increased up to a maximum of 4:1 by the pharmacist in charge based upon public safety considerations but only if the additional pharmacy technicians are certified pharmacy technicians.

If no certified technicians are in the pharmacy, the technician to pharmacist ratio is 2:1 (two technicians to one pharmacist). If one certified technician is in the pharmacy, the ratio increases to 3:1. If two technicians are in the pharmacy and certified, the ratio increases to 4:1 (four total technicians to one pharmacist). Remember that all technicians, certified or not, must be registered with the Tennessee Board of Pharmacy.

The pharmacist in charge may request a modification of the ratio from the Board in writing which addresses:

1. the pharmacy technician’s experience, skill, knowledge and training; and

2. the workload at the practice site; and

3. detailed information regarding the numbers of pharmacy technicians and the specific duties and responsibilities of each of the pharmacy technicians; and

4. justification that patient safety and quality of pharmacy services and care can be maintained at the pharmacy.

(b). Requested modifications of the established ratios may not be implemented until the written request is considered and approved by the Board.

Section 2 Question 24 Question, Answer and Explanation Are Changed.

A prescriber who treats a patient with more than sixteen milligrams (16 mg) per day of buprenorphine or its therapeutic equivalent for more than thirty (30) consecutive days for treatment of opioid dependence shall clearly document in the patient’s medical record why the patient needs the higher dosage amounts of buprenorphine.

True or False

True, [https://www.nabp.net/system/rich/rich_files/rich_files/000/001/199/original/tn122015.pdf, Tennessee News Letter December 2015 Page 4].

A prescriber who treats a patient with more than sixteen milligrams (16 mg) per day of buprenorphine or its therapeutic equivalent for more than thirty (30) consecutive days for treatment of opioid dependence shall clearly document in the patient’s medical record why the patient needs the higher dosage amounts of buprenorphine.

A prescriber who does not meet the requirements established in the manner described in subdivision (d)(2) and treats a patient with more than twenty milligrams (20 mg) per day of buprenorphine or its therapeutic equivalent for more than thirty (30) consecutive days for treatment of opioid dependence shall, to the extent possible, either consult with an addiction specialist meeting the requirements established in the manner described in subdivision (d)(2) or refer the patient to the addiction specialist for management of the patient’s treatment plan.

If a prescribing physician cannot make the required consultation or referral as outlined in this subsection (d), the reasons shall be set out in the medical record.

Therefore, if a prescription is received in a Tennessee registered pharmacy, the Board advises pharmacists to contact the prescribing practitioner, document the reasons for the increased dosage amount, and use professional judgement as to whether to fill or deny to dispense the prescription as he or she would with any medication.

Section 3 Question 18 Question, Answer and Explanation Are Changed.

Which of the following is/are TRUE about pharmacy internship requirements?

I. An applicant for an initial pharmacist license by examination must show, on affidavit forms prescribed by the board, that the applicant has acquired a minimum of 1700 hours of pharmacy internship (practical pharmacy experience) under the instruction of a pharmacist.

II. Foreign pharmacy graduates shall complete 500 hours of pharmacy internship in Tennessee within a period of 6 consecutive months.

III. 400 hours of these 1700 hours may be acquired in non-traditional pharmacy internship programs which have received prior approval of the board.

a. I only
b. I and II only
c. II and III only
d. All

I and II only, [Rules of the Tennessee Board of Pharmacy 1140-01-.04].

An applicant for an initial pharmacist license by examination must show, on affidavit forms prescribed by the board, that the applicant has acquired a minimum of one thousand seven hundred (1,700) hours of pharmacy internship (practical pharmacy experience) under the instruction of a pharmacist in good standing, subject to all of the following conditions.

(a). The one thousand seven hundred (1,700) hours must be acquired after enrollment in a recognized college or school of pharmacy; one thousand seven hundred (1,700) of these hours must be acquired in pharmacy programs or demonstration projects structured by the college or school of pharmacy.

(b). Pharmacy internship may be acquired in another state, provided that the preceptor’s qualifications are certified by the appropriate authorities of such state.

(c). Foreign pharmacy graduates shall complete five hundred (500) hours of pharmacy internship in Tennessee within a period of six (6) consecutive months.

Section 4 Question 5 Question, Answer and Explanation Are Changed.

Which of the following is/are TRUE regarding schedule II or III controlled substances under Tennessee Pharmacy Act?

I. A controlled substance included in Schedule V shall not be distributed or dispensed other than for a medical purpose.

II. No prescription for a Schedule II substance may be refilled.

III. No prescription for any opioids or benzodiazepines may be dispensed in quantities greater than a thirty-day supply.

a. I only
b. I and II only
c. II and III only
d. All

All, [Tennessee Code Annotated, Section 53-11-308(d)(e) and Bill HB1264].

(a). Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, no controlled substance in Schedule II may be dispensed without the written prescription of a practitioner.

(b). In emergency situations, Schedule II drugs may be dispensed upon oral prescription of a practitioner, reduced promptly to writing and filed by the pharmacy. Prescriptions shall be retained in conformity with the requirements of § 53-11-305. No prescription for a Schedule II substance may be refilled.

(c). Except when dispensed directly by a practitioner other than a pharmacy to an ultimate user, a controlled substance included in Schedule III or IV that is a prescription drug shall not be dispensed without a written or oral prescription of a practitioner. The prescription shall not be filled or refilled more than six (6) months after the date of the written or oral prescription or be refilled more than five (5) times, unless renewed by the practitioner.

(d). A controlled substance included in Schedule V shall not be distributed or dispensed other than for a medical purpose.

(e). No prescription for any opioids or benzodiazepines may be dispensed in quantities greater than a thirty-day supply.

(f). If a prescriber dispenses any opioids, benzodiazepines, barbiturates, or carisoprodol, then the prescriber shall submit the transaction to the controlled substances monitoring database operated under chapter 10, part 3 of this title.

(g). Any prescribers of opioids, benzodiazepines, barbiturates or carisoprodol, either alone, concurrently, or sequentially with any other opioids, benzodiazepines, barbiturates, or carisoprodol to patients who are in chronic, long-term drug therapy for ninety (90) days or longer shall consider mandatory urine drug testing.

This subsection (g) shall not supercede any rules promulgated by the commissioner for urine drug testing by registered pain management clinics.

Section 4 Question 6 Question, Answer and Explanation Are Changed.

Oxygen is a drug and therefore requires prescribing in all but emergency situations.

True or False

True. Oxygen is a drug and therefore requires prescribing in all but emergency situations. In the emergency situation oxygen prescription is not required.

Before oxygen therapy is prescribed there are guidelines or criteria that must be met. These criteria involve a blood test. (These blood test criteria must also be met for Medicare and other insurers to pay for the oxygen costs.)

Medical experts produced the criteria. They establish what the levels of oxygen in the blood must be for oxygen therapy to be needed.

These guidelines describe three conditions that require the use of oxygen therapy:

1. PaO2 is less than or equal to 55 mmHg. Or hemoglobin oxygen saturation (SaO2) measured by pulse oximeter is less than or equal to 88 percent when breathing room air at rest.

2. PaO2 of 56-59 mmHg. Or if the hemoglobin oxygen saturation (SaO2) is equal to or greater than 89 percent when linked to specific conditions. These may include Cor Pulmonale, congestive heart failure or erythrocytosis. (With a hematocrit of greater than 56 percent.)

(Erythrocytosis means there are more red cells in the blood than normal. Hematocrit measures the percentage of cells in a sample of blood.)

3. Some individuals do not qualify for oxygen therapy while at rest. But they may require oxygen while walking, exercising or during sleep. Oxygen therapy is needed in these cases when the hemoglobin oxygen saturation (SaO2) falls to less than or equal to 88 percent.

Also, for the costs of oxygen to be covered by insurance there must be proof that the oxygen therapy used during exercise or sleep improves the individual's hypoxemia.

A physician must write a prescription for oxygen therapy prior to delivery. The prescription will indicate the flow rate, how much oxygen you need per minute -- referred to as liters per minute (LPM) -- and when a patient needs to use oxygen.

Also necessary is Diagnosis, portability (if needed), and length of need. Some people use oxygen therapy only while sleeping, others only while exercising, and still others need oxygen continuously.

The physician will order a blood test or oximetry test that will indicate what the patient's oxygen level is and help determine what his/her needs are. A written prescription is required prior to delivery.

Certain insurance polices may pay for all your oxygen, but payment is based on laboratory results, diagnosis, and other information. The information listed below will help to determine insurance coverage.

Medicare – In addition to a prescription, Medicare requires a Certificate of Medical Necessity (CMN) to be filled out by your physician. CMN Oxygen requirements are as follows:

1. Length of need
2. Diagnosis, a respiratory ailment showing the need for oxygen
3. Oxygen Blood Gas to be 56-59 or below, or Oxygen Saturation level to be 89 or below
4. How the test was taken, room air, during exercise, or while sleeping
5. The testing facility where blood gasses or oximetry was performed
6. Portability if needed
7. Liter flow prescribed
8. Physicians Signature
9. Date

Section 5 Question 6 Question, Answer and Explanation Are Changed.

Under Tennessee Prescription Safety Act of 2012, each dispenser shall, regarding each controlled substance dispensed, submit to the committee all required information at least once every 15 days.

True or False

False, [Tennessee Pharmacy Practice Act of 1996 53-10-305(a),(b), Effective January 1, 2016].

(a). All prescribers with DEA numbers who prescribe controlled substances and dispensers in practice providing direct care to patients in Tennessee for more than fifteen (15) calendar days per year shall be registered in the controlled substance database.

New licensees shall have up to thirty (30) calendar days after notification of licensure to register in the database. Licensed veterinarians who never prescribe a controlled substance in an amount intended to treat a non-human patient for more than forty-eight (48) hours shall not be required to register in the database.

(b). (1). Each dispenser or dispenser's agent shall, regarding each controlled substance dispensed, submit to the database all of the following information:

(A). Prescriber identifier;

(B). Dispensing date of controlled substance;

(C). Patient identifier;

(D). Controlled substance dispensed identifier;

(E). Quantity of controlled substance dispensed;

(F). Strength of controlled substance dispensed;

(G). Estimated days supply;

(H). Dispenser identifier;

(I). Date the prescription was issued by the prescriber;

(J). Whether the prescription was new or a refill;

(K). Source of payment; and

(L). Other relevant information as required by rule.

(2). The information in the database, as required by subdivision (b)(1), shall be submitted by a procedure and in a format established by the committee, for each business day but no later than the close of business on the following business day (NOT every 15 days); provided, that a veterinarian shall submit information at least once every seven (7) days and shall not be required to use a computerized system in order to submit required information pursuant to this section.

(c) The committee shall have the authority to shorten the length of time dispensers are required to submit to the database through the promulgation of rules pursuant to the Uniform Administrative Procedures Act, compiled in title 4, chapter 5.

When the committee shortens the length of time dispensers are required to submit to the database, the department shall provide notice to all dispensers who are registered in the database at least sixty (60) days prior to the date in which the rule goes into effect.

If the committee shortens the length of time which dispensers must submit information to the database, a dispenser may provide to the committee a written statement indicating why it creates a hardship for that dispenser to submit information within that time period, and the committee may grant an extension up to seven (7) days within which that dispenser must submit the information to the database.

Such a hardship extension shall be valid for two (2) years and may be renewed by the committee upon request of the dispenser.


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June 23, 2016 Delaware Law Requires ID to Buy Certain Cough Medicines


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A new Delaware law restricts the sale of over-the-counter (OTC) medicines containing dextromethorphan (DXM) to those aged 18 and older.

Intended to reduce abuse of the cough suppressant among teens, the law requires an ID to be presented at the point of purchase.

Delaware is the 12th state to impose a DXM restriction, reports Drug Store News.


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June 23, 2016 New Hampshire Pharmacies May Establish Drug Take-Back Programs Under New Law


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Retail pharmacies in New Hampshire are authorized to establish pharmaceutical drug take-back programs if their program meets certain federal requirements.

House Bill (HB) 1490 was signed into law by Governor Maggie Hassan and is effective August 6, 2016. Under HB 1490, a registered pharmacy may establish a drug take-back program to collect controlled and non-controlled pharmaceutical drugs.

New Hampshire RSA 318-E:1 defines “pharmaceutical drug” as a prescription or OTC drug, including controlled drugs.


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June 16, 2016 Alaska Regulates Sale of Dextromethorphan Products to Adults, Requires Prescription for Persons Under 18 Years of Age.


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The sale of products containing dextromethorphan in Alaska is restricted to individuals 18 years of age or older under a new law. House Bill 125 states products containing dextromethorphan may be sold if the person is under 18 years of age and has a prescription for the product from a licensed practitioner.

Alaska is the 11th state to restrict the sale of products containing dextromethorphan to adults and to require a prescription from a practitioner for individuals younger than 18 years, reports the American Pharmacists Association.


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June 13, 2016 New York Pharmacy Law Updates/Corrections


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Section 1 Question 27 Question Is Updated

Which of the following is/are CLASSIFIED as Schedule IV controlled drug(s)?

I. Oxazepam
II. Zaleplon
III. Butorphanol

a. I only
b. I and II only
c. All
d. None of the above

Answer: None of the above.


Which of the following is/are TREATED AS Schedule II controlled drug(s) under the New York State Pharmacy Law?

I. Oxazepam
II. Zaleplon
III. Estazolam

a. I only
b. I and II only
c. All
d. None of the above

Answer: All.


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June 9, 2016 Arizona Pharmacists Now Able to Substitute Prescriptions for Interchangeable Biological Products.


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Beginning December 31, 2016, pharmacists in Arizona will be allowed to substitute an interchangeable biological product for a prescribed biological product if certain conditions are met, including if the prescribing physician does not indicate an intent to prevent substitution with such product on the prescription.
 
Under the new law, a pharmacist may make the substitution if US Food and Drug Administration (FDA) has determined the substituted product is an interchangeable biological product. In addition, the pharmacy is required to inform the patient of the substitution. The pharmacist (or pharmacist’s designee) is also required to make an entry of the specific product dispensed to the patient in an interoperable electronic medical records system that is accessible to the prescriber within five business days after dispensing a biological product.

The pharmacist may communicate to the prescriber which biological product was dispensed using fax, telephone, or other means. The communication must include the name of the product and the manufacturer. The pharmacist is also required to place on the container the name of the biological product dispensed followed by the words “interchangeable biological product for” followed by the brand or trade name of the product that is being replaced by the interchangeable biological product.
 
The law also states that the Arizona State Board of Pharmacy is required to maintain a link on its website to the current list of each biological product determined by FDA to be an interchangeable biological product. House Bill 2310 was signed into law by Governor Doug Ducey on May 17, 2016, and is effective beginning on December 31, 2016.


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June 6, 2016 Kentucky Pharmacy Law Updates And Corrections.


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Section 4 Question 21 Answer Explanation Is Updated

The data shall be transmitted within seven (7) days (NOT 15 days) of the date of dispensing unless the cabinet grants an extension.

Effective July 1, 2013, the data shall be transmitted no later than close of business on the business day immediately following the dispensing unless the cabinet grants an extension.

Section 5 Question 30 Answer Choices, Answer and Explanation are Updated

According to Kentucky State Pharmacy Law, which of the following mid-level practitioners may prescribe and/or dispense a Schedule II controlled substances in the course of their professional practices?

I. Nurse practitioner
II. Optometrists
III. Physicians assistant

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

OD (Optometrists): Can prescribe or administer or both Schedule III, IV and V controlled substances. Prescribe Only Schedule II Hydrocodone containing products.


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June 5, 2016 Hawaii Pharmacy Law Updates And Corrections.


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Section 1 Question 3 Explanation And Answer Are Changed

All I and II only
Submits evidence that the applicant has practiced for at least two thousand hours fifteen hundred hours as a licensed pharmacist within the five years preceding the date of application.

Section 1 Question 7 Question Is Changed

All licensees and permit holders shall complete and submit a renewal application together with the required fees on or before December 31 of the odd-numbered year.

True or False

True, [Hawaii Administrative Code Subchapter 9 Section 16-95-70].

All licensees and permit holders shall complete and submit a renewal application together with the required fees on or before December 31 of the odd-numbered year.

A completed renewal application with the required fees sent by the United States mail shall be considered timely filed if the envelope bears a postmark no later than December 31 of the odd-numbered year or if filed on-line with the department by that date.

Section 2 Question 7

Pharmacist assistance should be replaced with Pharmacy-Intern

Section 2 Question 8 Question and Explanation Are Changed.

According to Hawaii State Pharmacy Law, drugs present in a night cabinet shall be inventoried no less than once per week.

According to Hawaii State Pharmacy Law, a night cabinet is a cabinet, room, or any other enclosure not located within the prescription area.

Answer: True, [Hawaii Administrative Rules (HAR) Title 16 Chapter 95 Section 16-95-80(c)(1),(2)].

A pharmacist in an institutional pharmacy shall ensure that written policies and procedures have been established by the institutional facility for provision of drugs to the medical staff and other authorized personnel of the institutional facility by use of night cabinets, and access to the institutional pharmacy and emergency kits when the pharmacist is not in the area.

A night cabinet is a cabinet, room, or any other enclosure not located within the prescription area. The development of an inventory listing of all drugs included in the cabinet and the requirements of the pharmacist ensures at a minimum that:

(A). Drugs available therein are properly labeled;

(B). Only prepackaged drugs are available therein in amounts sufficient for immediate therapeutic requirements;

(C). An appropriate practitioner's prescription regarding the dispensing of drugs exists.

(D). All drugs therein are inventoried no less than once per calendar quarter (NOT WEEKLY); and

(E). A complete audit of all activity concerning such cabinet is conducted no less than once per month.


Section 2 Question 18 Explanation Is Changed.

(a). The purpose of the collaborative agreement is to permit emergency contraception drug therapy within one hundred and twenty hours of the patient having unprotected sexual contact and to ensure that the patient receives appropriate information from the licensed pharmacist regarding the drug therapy.

Each arrangement between a licensed pharmacist and a licensed physician relating to the distribution to a patient of emergency contraception drugs shall be documented in a signed collaborative agreement in accordance with the form attached as Exhibit “A.”

The agreement shall be delivered to the department by the licensed pharmacist within seven days ten days of the execution of the agreement by the pharmacist and the physician.


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