Alabama Board of Pharmacy

Proposed Adoption of New Rule
Public Hearing Date 6/26/2018.

Proposed Amendment to an Existing Rule
Public Hearing Date 6/26/2018.


Standing Order of the State health Officer Naloxone Distribution For Overdose Prevention
- From the Alabama Department of Public Health.


The Board’s February 2016 Newsletter was the last printed issue. Going forward, all future Board newsletters will be provided as a downloadable PDF posted on the [Board’s website/NABP website]. Licensees can sign up for a free email alert to receive a reminder whenever a new issue of the Newsletter becomes available. To sign up for the email alert, visit the Board’s contact page in the Boards of Pharmacy section of the NABP website at www.nabp.pharmacy, and click the subscribe link. The Board is undertaking this effort to deliver updates as timely as possible and make the information more easily accessible.
- Newsletter Goes Electronic.

The compound Tamiflu suspension during the shortage.


Proclamation terminating the State of Emergency.


Please see the attached proclamation from Governor Ivey. The EMA will be activated on Friday 10/6/2017 7:00 AM.
This proclamation does extend the 72 hour emergency fills to 30 days (sections a-d) and allows pharmacies to use insurance claims,
medication bottles, etc to determine the prescription for those affected by the hurricane/ tropical storm. Waivers do not apply to controlled substances.


Governor's proclamation attached which ends the waivers at 11:59 tonight for hurricane evacuees
with the exception of limits to commercial motor carriers and drivers.


PROCLAMATION BY THE GOVERNOR – HURRICANE IRMA    


New Rule Submitted to Legislation!    


Oppositions can be directed to Wendy Passmore at the Alabama Board of Pharmacy from July 1, 2017 until August 4, 2017. Please present your views in writing, fax or email.

Wendy Passmore
Legal / Executive Assistant
111 Village Street
Birmingham, Al 35242
Phone 205-981-4764
Fax 205-803-6481
Email - wpassmore@albop.com

Amended Rule Submitted to Legislation!


Oppositions can be directed to Wendy Passmore at the Alabama Board of Pharmacy from July 1, 2017 until August 4, 2017. Please present your views in writing, fax or email.

Wendy Passmore
Legal / Executive Assistant
111 Village Street
Birmingham, Al 35242
Phone 205-981-4764
Fax 205-803-6481
Email - wpassmore@albop.com

30 DAY TO 90 DAY FILLING
ATTENTION ALL PHARMACISTS!

The Board issued a new policy statement regarding changing a 30-day supply to a 90-day supply. If a legend medication is written by a physician and it's given a 30- day supply with an appropriate number of refills, the pharmacist can fill that prescription as a 90-day supply with the commensurate number of refills without contacting the physician to obtain a new prescription. For example, if a prescription is written with 5 refills, you may fill it as two 90-day supply prescriptions. This will aid the public health in being able to give the patient a 90-day supply at a time and improving compliance.

ALBOP LEGISLATION PASSED:

PROVIDER STATUS FOR PHARMACISTS IS OFFICIAL!
ALBOP legislation, HB170, passed yesterday afternoon, which clarifies the definition of a pharmacist: "PHARMACIST. Any person licensed by the board to practice the profession of pharmacy AS A HEALTH CARE PROVIDER in the State of Alabama and whose license is in good standing."

This is a big step forward for pharmacy in Alabama, and we are so excited for the positive changes this new legislation will bring! Congratulations to all pharmacists in the state, and thank you for your constant support, unity, and drive to advocate for this profession.

Xanax Announcement   

ALABAMA STATE BOARD OF PHARMACY

111 Village Street, Hoover, AL 35242

NOVEMBER AGENDA  

RULE MAKING HEARING

680-x-2-.20 NUCLEAR PHARMACY.

2017 Meeting Schedule 

Elected by Alabama Pharmacists

Congratulations!

Ralph Sorrell, R.Ph.

Term of Service

January 1, 2016 to December 31, 2020

PLEASE NOTE: Effective January 1, 2011, ONLY ACPE programs or courses may be used to satisfy Continuing Education requirements. This includes programs for Pharmacists and Technicians. Consultant, Preceptor, and Parenteral Certification require training that has been approved by the Board prior to the event and may be submitted to obtain or renew the certificate whether ACPE approved or not. However, unless ACPE approves the program it cannot count toward mandatory CE hours.

Effective August 18, 2014

The US Drug Enforcement Administration today published its Final Rule in the Federal Register placing tramadol into Schedule IV effective August 18, 2014.

A number of states in the country including Arkansas, Mississippi and New York have already placed tramadol as a controlled substance.

Acknowledging that changes such as these take time to implement, the DEA extended the usual effective date for this type of change from 30 to 45 days to provide what it considers to be "reasonable time for registrants to comply with handling requirements for a schedule IV" drug, such as moving tramadol products into a warehouse cage or adjusting suspicious monitoring systems to include tramadol orders.

Effective August 18, 2014 all manufacturers will be required to print the designation C-IV on every bottle and it is unlawful for commercial containers of tramadol to be distributed without that designation. In addition, all DEA registrants will be required to take an inventory of all tramadol stock in compliance with 21 C.F.R. § 1304.11(d).

Click here for Final Rule

REQUIREMENTS FOR E-PRESCRIBING OF CONTROLLED SUBSTANCES

Click here for Final Rule

In response to the shortage of saline solutions, the FDA has approved the import of saline from Baxters facility in Spain and from Fresenius Kabi in Norway. Please see the FDA statements following:

[03/28/2014] Due to the shortage of 0.9% sodium chloride injection7 (normal saline) Fresenius Kabi USA, LLC8 of Lake Zurich, Ill., will temporarily distribute normal saline in the United States from its Norway manufacturing facility. FDA is temporarily exercising enforcement discretion for the distribution of Fresenius Kabi USAs normal saline product while it is needed to address this critical shortage that directly impacts patients. Please contact the Fresenius Kabi USA directly to obtain the product.

[04/28/2014] In response to the ongoing shortage of 0.9% sodium chloride injection1 (normal saline),Baxter Healthcare Corp.2 of Deerfield, Ill., will temporarily distribute normal saline in the United States from its Spain manufacturing facility.

In addition to these sources of normal saline, U.S.based manufacturers Baxter Healthcare Corp. 3, B.Braun Medical Inc.4, and Hospira Inc.5, are currently producing and releasing normal saline.

Medisca, Inc, has initiated a voluntarily recall of several lots of L-citrulline products after testing confirmed they did not contain the active ingredient; subsequently, FDA also confirmed the presence of N-acetyl-leucine. Medisca urges health care providers to examine their stocks and to immediately discontinue dispensing any products from the following lots:

• 95482/A, 95482/B, 95482/C, 95482/D
• 96453/A, 96453/B, 96453/C, 96453/D

Instructions for returning the products are available in a Medisca press release (PDF). Health care providers, patients, and caregivers are encouraged to report any adverse events or quality problems associated with L-citrulline to FDA’s MedWatch Safety Information and Adverse Event Reporting Program

A Food and Drug Administration (FDA) decree has prohibited Ranbaxy Laboratories, Ltd, from manufacturing and distributing active pharmaceutical ingredients (APIs) from the company’s facility in Toansa, India, for use in FDA-regulated drug products. An inspection of the facility on January 11, 2014, identified significant current good manufacturing practice violations, including retesting of raw materials, intermediate drug products, and finished APIs in order to produce acceptable findings after items failed analytical testing and specifications. According to an FDA press release, the facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.

Under the decree, FDA has issued an order prohibiting Ranbaxy from:

• Distributing drugs manufactured using APIs from Toansa in the United States, including drugs made by Ranbaxy’s Ohm laboratories in New Jersey;
• Manufacturing APIs at its Toansa facility for FDA-regulated drug products;
• Exporting APIs from Toansa to the US for any purpose; and
• Providing APIs from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.

If FDA determines that a medically necessary drug is in shortage or at risk of shortage as a result of this action, the agency may modify this order in order to preserve patient access to the drugs manufactured under controls that are sufficient to assure quality, safety, and effectiveness, indicates the press release.

FROM THE FDA:

We have received a number of questions about the use of codeine products. In 2010, the FDA required four manufacturers of codeine products to withdraw their products from the market because the products had not been approved by the FDA. It appears that this action is a follow-up to remove any unapproved codeine products from the market. It also appears that approved codeine products will remain on the market and available. Below we have listed those products which we found on the FDA website showing active drugs. We have also attached the FDA notice from February and provided the website for an additional from January. We are sorry for the confusion about removal of all codeine products as indicated by our first notice of removals.

Link here to the complete article.

NOTIFICATION TO ALL LICENSEES

Re : Notice to Licensees About Fraudulent Documents

12/5/2013: FDA and Baxter International Inc, have issued a voluntary recall of one lot of nitroglycerin in 5% dextrose injection due to the presence of particulate matter found in one vial. According to a press release released by the company, particulate matter, if infused, could lead to potential venous and/or arterial thromboembolism, inflammation (particularly in the lungs),and irritation of blood vessels. To date, there have been no adverse events associated with the use of the recalled products.

The affected medications were distributed in the United States between January 17, 2013 and October 10, 2013, and are packaged in 250 mL glass containers, with 12 containers per carton. The affected product code is 1A0694, and the affected lot number is G105197. Consumers and health care providers should immediately stop using any products affected by the recall. Those affected may contact Baxter Healthcare Center for Service at 888/229-0001 between 7 am and 6 pm, Central Time to arrange for return and replacement.

FDA recommends health care professionals discontinue prescribing and dispensing prescription combination drug products with more than 325 mg of acetaminophen to protect consumers.

Click here for PDF file

On December 2, 2013, the Federal Drug Enforcement Administration placed Perampanel into Schedule III of the Federal Controlled Substances List, to be effective January 2, 2014.

Click here for PDF file

NEW ALABAMA LEGISLATION

GIVES CONTROL DRUG PRESCRIBING AUTHORITY

TO CERTIFIED NURSE PRACTITIONERS AND MIDWIVES

Click here for PDF file

EFFECTIVE JUNE 9, 2014

680-X-2-.07 MAIL ORDER PRESCRIPTIONS  

Every Pharmacy shall take a new inventory of all stocks of controlled substances on hand January 15th or the alternative fixed date approved by the Board of each year following the date the initial inventory was taken.

680-X-3-.08 ANNUAL INVENTORY OF CONTROLLED SUBSTANCES 

CHAPTER 540-X-18

QUALIFIED ALABAMA CONTROLLED SUBSTANCES REGISTRATION CERTIFICATE (QACSC)

FOR CERTIFIED REGISTERED NURSE PRACTITIONERS (CRNP) AND CERTIFIED NURSE MIDWIVES (CNM)

Update on QACSCs for CRNPs and CNMs Click here for PDF file

HOW TO HANDLE VACCINES SAFELY: Rules about Prefilling and Storing Vaccines

Click here for PDF file

The US Drug Enforcement Administration (DEA) on October 19, 2011 issued clarification in the Federal Register stating that pharmacy software that receives prescriptions for controlled substance electronically must meet required components of the law, particularly that concerning security. DEA currently requires that these computer applications must be tested by an approved company to ensure that it conforms to all applicable requirements in law (21 CFR 1311). Additionally, the notice reminds individuals that DEA has an approved certification process for controlled substances (EPCS) software on its Web site. DEA also provided resources to consult when questions arise concerning a particular EPCS prescriber or pharmacy application as well as for interpretation of DEA's EPCS regulations as applied to specific software.

Utilizing Controlled Substances for Weight Reduction- New Rule

Updated September 15, 2014

Link to the Rule: www.albme.org/Documents/Rules/540-X-17.pdf

Frequently Asked Questions:

1. May a physician prescribe a Schedule II controlled substance for patients for the purpose of weight reduction? NO

2. May a physician or agent of a physician call in orders for controlled substances for patients for the purpose of weight reduction? NO

3. May anyone other than a licensed MD or DO prescribe controlled substances for weight reduction? NO Examples of weight loss drugs covered by this policy:

Belviq -- Lorcaserin
Qsymia -- Phentermine - topiramate
Fastin; Adipex; Suprenza - Phentermine
Tenuate -- Diethylpropion
Bontril -- Phendimetrazine
Ionamin -- Phentermine resin
Didrex -- Benzphetamine

Note: These are instructions to physicians on what they are supposed to do

Standard Operating Procedures Manual

Documentation is on file for EACH person who compounds sterile products that they are adequately skilled, educated, instructed and trained to correctly perform and document the following activities:

1. Perform aseptic hand cleansing

2. Perform disinfection of compounding surfaces

3. Select and appropriately don protective garb

4. Maintain or achieve sterility of CSPs

5. Protect personnel and compounding environment from contamination by hazardous drugs if applicable

6. Identify, weigh and measure ingredients

7. Manipulate sterile products aseptically

8. Sterilize high-risk CSPs if applicable

9. Label and quality inspect CSPs

Prescription Drug Monitoring Program

PHARMACISTS

To register as a user of the Prescription Drug Monitoring Program database, go to www.adph.org/PDMP and click on the Practitioner Access link or the Pharmacist Access link and follow the instructions.

ALABAMA ADMINISTRATIVE CODE

Have you seen the FDA & ISMP's medication safety videos?

Watch them here!

The Latest Board Statistics & Board Facts

Pharmacy Permits
Diane Decker

Technician Registration
License Verification
Rhonda Coker

Subpoenas and Hearing Dates
General and Legal Questions
Mitzi Ellenburg

Pharmacist Licensure
Intern/Extern Hour Status
Lynn Martin

Complaints or Investigative Issues
Eddie Braden

Sterile Products
Susan Alverson

Board Attorney
Jim Ward

Technician/Information Technology
Terry Lawrence

Law / Legislative Affairs
Call Office - 981-2280