Showing posts with label Office Use. Show all posts
Showing posts with label Office Use. Show all posts

Saturday, February 22, 2014

Bill introduced into Colorado to allow prescription drug outlet to distribute compounded drugs for office use to hospitals

SB14-095 Pharmacies Compounding Drugs For Hospitals 
Amendments:
Date Introduced:2014-01-22
Status:02/11/2014 Introduced In House - Assigned to Health, Insurance, & Environment
Summary:Under current law, a prescription drug outlet may only distribute compounded drugs for office use to practitioners who are authorized to prescribe drugs. The bill allows a prescription drug outlet to also distribute compounded drugs to a hospital located in Colorado.
Calendar Notification: Tuesday, March 4 2014
Health, Insurance & Environment
Upon Adjournment Room 0107
(1) in house calendar.
Sponsors:KEFALAS / MCCANN

Sunday, June 2, 2013

Question of the Day June 2, 2013 With So Many States Addressing Office Use or Prescriber's Use Wouldn't It Make More Sense to Have One Standard Rule or Regulation Whether Through the States or the Federal Government Stating the Terms of Office or Prescriber's Use (Which IS ESSENTIAL TO Doctors, Dentists and Veterinarians)


Louisiana Board of Pharmacy Status of Compounding for Prescriber's Use limited to 10 Percent --Notice of Emergency Rule has been Published and Distributed

2013-1.2 ~ Compounding for Prescriber's Use  [Source: Regulatory Proposal 2013-E]
               01-29-2013     Board issued Declaration of Emergency & Emergency Rule, to become effective on 01-31-2013.
               01-30-2013     Distributed required Notice of Emergency to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.
               01-30-2013     Distributed electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.
               05-29-2013     Board re-issued Declaration of Emergency & Emergency Rule, effective immediately.
               05-30-2013     Distributed required Notice of Emergency Rule to Offices of the Governor, Attorney General, President of the Senate, Speaker of the House of Representatives, and Director of the Louisiana Register.
               06-01-2013     Distributed electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.


letter, notice, and proposed rule can be viewed here

Saturday, June 1, 2013

Tennessee New Statute Regarding Office Use


Statute Amended Regarding Compounding
As stated in Public Chapter 266, TCA 63-10-204(4), the definition
of “compounding” includes the following new language:
(D) For use in a licensed prescribing practitioner’s office for
administration to the prescribing practitioner’s patient or
patients when the product is not commercially available
upon receipt of an order from the prescriber;
(E) For use in a health care facility for administration to
a patient or patients receiving treatment or services
provided by the facility when the product is not commercially
available upon receipt of an order from an
authorized licensed medical practitioner of the facility;
(F) For use by emergency medical services for administration
to a patient or patients receiving services from them
under authorized medical control when the product is
not commercially available upon receipt of an order
from a licensed prescriber authorized to provide medical
control; or
(G) For use by a licensed veterinarian for administration
to their non-human patient or patients or for dispensing
to non-human patients in the course of the practice
of veterinary medicine upon receipt of an order from
a veterinarian when the product is not commercially
available.
In TCA 63-10-204(12), the definition of “dispense” now reads
as follows:
. . . “Dispense” means preparing, packaging, compounding
or labeling for delivery and actual delivery of a prescription
drug, nonprescription drug or device in the course of
professional practice to a patient or the patient’s agent, to
include a licensed health care practitioner or a health
care facility providing services or treatment to the patient
or patients, by or pursuant to the lawful order of a
prescriber . . .
TCA 63-10-216 adds this section as follows:
(a) Prior to initial licensure in this state as a compounding
pharmacy, a pharmacy located outside of this state

must have an inspection by the regulatory or licensing
agency of the state in which the pharmacy practice site
is physically located. Out-of-state pharmacy practice
sites must provide a copy of the most recent inspection
by the regulatory or licensing agency of the state in
which the pharmacy practice site is physically located,
which must have been within the previous twelve (12)
months. Prior to renewal of its license in this state, an
out-of-state pharmacy practice site must provide the
most recent inspection by the regulatory or licensing
agency of the state in which the pharmacy practice site
is physically located or equivalent regulatory entity,
and which must have been within the previous twelve
(12) months. The board of pharmacy shall have the
right to require additional information before issuing or
renewing a pharmacy license to insure compliance with
applicable laws of this state and any rules and policies
of the board.
(b) Any compounding pharmacy having an active Tennessee
license shall notify the board within fourteen (14)
business days of receipt of any order or decision by a
regulatory agency, other than the Tennessee board of
pharmacy, imposing any disciplinary action, including
any warning, on the pharmacy.
(c) Any pharmacies engaged in sterile compounding must
comply with relevant United States Pharmacopeia (USP)
guidelines as adopted by the board by rule or policy.
(d) Any pharmacies engaging in sterile compounding, except
hospital pharmacies compounding for inpatients of
a hospital, shall report on a quarterly basis to the board
the quantity of sterile compounded products dispensed
in a defined time period in accordance with policies
adopted by the board; provided, however, the executive
director of the board may request this information from
a hospital pharmacy for cause and the hospital pharmacy
shall be required to respond in a timely manner as defined
by the executive director of the board.
The Board plans to discuss rules and policies for additional clarification
to the statute in the near future.
In regard to federal compounding regulations, be advised to
continually monitor United States Code 21 353. The current
regulation may be found at the following Web link: www
.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
PharmacyCompounding/ucm155666.htm.

Quoted from Tennessee Board of Pharmacy June 2013 Newsletter

West Virginia Board of Pharmacy Discusses Compounding v. Manufacturing --Compounding for Office Use--Limited Office Use is Permitted --Invoice


Compounding Versus Manufacturing:
Compounding for Office Use
Last quarter, the Board discussed compounding pursuant to
a prescriber’s order (prescription) versus manufacturing. That
article concluded, in part, “ . . . unless it is for a research, teaching
or other similar situation which is not for sale or dispensing,
pharmacies may compound only for individual prescriptions,
or in anticipation of their regular and routine prescriptiondispensing
needs.” However, during the legislative session,
representatives of ophthalmologists expressed concern about
being able to get certain eye drops prepared for their office
use with their patients during certain routine procedures. They
indicated that the solutions are not available on the market and
must be compounded, and that the current law would require
them to write or call in prescriptions for the patient to pick up
and bring with them to appointments. They suggested that this
would be inconvenient and unnecessarily costly for the patients,
often requiring patients to make a second visit because the doctor
would not know until during the initial examination that the
drops would be needed, requiring the exam to be postponed
until the drops could be prescribed, prepared, and picked up
by the patient. As a result, the Board discussed at the March
Board meeting whether to permit limited compounding done
“for office use,” or whether a prescription is always required.
After some discussion, the Board determined that it is in
the best interest of the patient to permit limited compounding
for office use in West Virginia. Therefore, the Board decided
that it would exercise discretion in enforcement with regard
to compounding for that purpose. The motion passed by the
Board stated that this would extend only to minimal amounts of
compounding necessary to fill an order placed by a prescriber

for use in his or her office in the immediate future. No bulk
compounding is permitted under this exception. Further, in no
event, whether for compounded drugs supplied for office use
or any other transfer of prescription drug stock for office use,
may this be documented as a prescription order. Because the
transfer of the compounded product would be done for a prescriber
to have in supply for general office use, the transaction
must be properly documented by invoice the same as any other
wholesale transaction. Finally, this very limited exception does
not in any way change the analysis that all other compounding
must be done for a prescription, or for a research, teaching,
or other similar situation that is not for sale or dispensing, as
required by law.

quoted from West Virginia Board of Pharmacy June 2013 Newsletter

Thursday, April 4, 2013

TN Senate drops drug rule Bill would allow compounding with no prescription for a specific patient


The Tennessee Senate on Thursday overwhelmingly approved a measure that would allow pharmacists to compound drugs without having a prescription for a specific patient, a key safeguard that exists under current law.
The measure was approved on a 29-1 vote, without a word of dissent, after a presentation by Sen. Ferrell Haile, R-Gallatin, who is a pharmacist. Sen. Todd Gardenhire, R-Chattanooga, cast the only vote against the bill.
A House version of the bill, sponsored by Rep David Shepard, a Dickson Democrat, has cleared the House Health Committee and is awaiting a House floor vote. Shepard, like Haile, is a pharmacist.
The Tennessee Pharmacists Association pushed for adoption of the bill, which would create a loophole for hospitals and other health care providers to obtain compound drugs without having to identify a patient. It would do so by permitting compounders to ship drugs without having received a patient-specific prescription in cases when a product “is not commercially available.
Continue reading here 

Sunday, March 24, 2013

West Virginia Board of Pharmacy Agenda for Meeting March 24, 2013--Discussion Included Compounding for Office Use and Whether allowed


AGENDA

Morgantown, West Virginia
Sunday, March 24, 2013
5:00 P.M. Marriott Residence Inn, Conference room.
1. Approval of December 16-17, 2012, Board Minutes.

2. Complaint Committee disciplinary recommendations. (Executive Session: Complaint Committee to address).

3. Building Renovation Update (Bid Process) (Executive Session: No Handout).

Recess.
Continue meeting on 3/25/13 at 8:00 a.m., at WVU School of Pharmacy, Room 1131 Conference Room.

Re-Adjourn
Morgantown, West Virginia
Monday, March 25, 2013
8:00 A.M. WVU School of Pharmacy, Rm 1131
Continued from 3/25/12

4. Consider Petition from Rite Aid for Declaratory Ruling and supporting proffer of evidence, seeking similar ruling as Kroger and Walgreen’s received concerning application of WV Code § 30-5-12b and generic substitution pricing language to cash transactions versus dispensings covered in whole or in part by insurance.

5. Request of Amy Crabtree to accept University of Kentucky College of Pharmacy Immunizations Training for pharmacist immunizations in lieu of APHA training.

6. Request of Dr. Clinton Sloan, DO, for Board to consider language in future rulemaking to state “ONLY IF NEEDED” on labeling rather than “prn” or “as needed”.

7. Request of applicant Steven Christopher Green for reciprocity for pharmacist license from Ohio, with prior discipline in Ohio to be considered.

8. Request of Medical Arts Pharmacy about the legality of using labeled multi-dose bubble packs and other containers for dispensing to ambulatory patients, with request for consideration of Rule 15-1-24 regarding use of specialized dispensing systems in health
institutions. Definition of “dispensing”, labeling requirements and other issues applying to the situation to be considered as well.

9. Request from Pharmacy Technician University to approve their Pharmacy Technician training course for use by any pharmacy to train their technician trainees.

10. Recommendations of the CPE Committee for changes to CPE rules in 15-3-1, et seq., for required continuing pharmacy education related to SB 437 (2012) for “drug diversion training and best practice prescribing of controlled substances training” and other clean-up.

11. Attendees and Delegate Selection at upcoming NABP Annual Meeting, May 18-21, 2013, St. Louis, MO.

12. Compounding for office use: permitted or disallowed in West Virginia?

13. Review of pending legislation of interest to the Board introduced during the Regular 2013 Legislative Session, including, but not limited to,
-HB 2577, the Pharmacy Practice Act;
-SB 11, changes to the controlled substances schedules (including whether hydrocodone in all forms and combinations should be a schedule II, or remain in Schedule III with or without further restrictions);
- SB 27, naloxone in emergency situations;
- HB 2729, epinephrine in emergency situations in schools, (SB 23 general use);
- SB 201, expedited partner therapy when encountering STD diagnoses;
- HB 2584, removing account sweeps language from Chapter 30, Article 1; and
- Board Rules and other legislation impacting directly on the practice of pharmacy or operation of the Board.

14. Any other business.

15. Schedule of next Board Meeting.

Adjourn.

Washington State Board of Pharmacy Compounding State of Feb. 25, 2013 Re: Office Use and Patient Specific


Compounding Statement of February 25, 2013
Washington State Board of Pharmacy
Chris Humberson, R.Ph.
Executive Director



The Washington State Board of Pharmacy recently discussed pharmacy compounding and specifically WAC 246-878-020(4) at their Feb 21, 2013 meeting.  The board has always read (4) in conjunction with other subsections which specifically require a prescription for a compounded drug.  However, they agreed that (4), read independently, could allow a pharmacy to provide compounded products for a practitioner to administer to individual patients without a prescription for a specific patient.  Because this has clearly been the belief of some compounding pharmacies in Washington, the board decided it will honor this interpretation of the rule

The Board will continue the rule making process on compounding practices as voted on during their January 10, 2013 meeting to make sure pharmacy compounding is done under the appropriate standards to protect the health and safety of the people of Washington. They will involve all stakeholders in this process.

________________
Doreen E. Beebe
Program Manager
Washington State Board of Pharmacy
PO Box 47852
Olympia WA  98504-7852                                                           
Phone 360/236-4834
Fax 360/236-2901
Public Health – Always Working for a Safer and Healthier Washington.


New Mexico Board of Pharmacy Agenda of April Meeting Posted--Considering Removing Office Use

http://www.rld.state.nm.us/boards/Pharmacy_Members_and_Meetings.aspx


d. 16.19.30 NMAC Compounding of Non-Sterile Pharmaceuticals
Remove section on compounding for practitioner’s office use
Proposed changes/additions are underlined. Proposed deletions are struck through. Public and professional comments are welcome. Please submit comments to the board through written correspondence within 15 days before the board meeting, fax number 505-222-9845, email Larry.Loring@state.nm.us or mail to 5200 Oakland Ave. NE Suite A, Albuquerque, NM 87113.
Interested persons may testify in person at the rule hearing. Please bring at least 15 copies of any handout you wish to distribute to the board.

To view complete April agenda click here

Monday, March 18, 2013

Reminder: New Office USe Rules Adopted in Florida--Effective Date March 31, 2013


64816-27.700 Definition of Compounding.
"Compounding" is the professional act by a pharmacist or other practitioner authorized by law, employing the science or art of any
branch of the profession of pharmacy, incorporating ingredients to create a finished product for dispensing to a patient or for
administration by a practitioner or the practitioner's agent; and shall specifically include the professional act of preparing a unique
fmished product containing any ingredient or device defined by Sections 465.003(7) and (8), F.S. The term also includes the
preparation of nuclear pharmaceuticals and diagnostic kits incident to use of such nuclear pharmaceuticals. The term "commercially
available products," as used in this section, means any medicinal product as defined by Sections 465.003(7) and (8), F.S., that are
legally distributed in the State of Florida by a drug manufacturer or wholesaler.
(1) through (2) No change.
(3) Office use compoundin&; "Office use" means the provision and administration of a compounded drug to a patient by a
practitioner in the practitioner's office or by the practitioner in a health care facil ity or treatment setting, including a hospital,
ambulatory surgical center, or pharmacy. A pharmacist may dispense and deliver a quantity of a compounded drug to a practitioner
for office use by the practitioner in accordance with this section provided:
(a) through (c) No change.
(d) The pharmacy and the practitioner enter into a written agreement. The acreement shall specifically provide:
l. That the compounded drug mav only be administered to the patient and may not be dispensed to the patient or sold to
any other person or entitv:
2. That the practitioner shall include on the patient's chart, medication order, or medication administration record the Jot
number and the bevond-use-date of any compounded drug administered to the patient that was provided by the pharmacy;
3. That the practitioner will provide notification to the patient for the reporting of any adverse reaction or complaint in
order to facilitate anv recall of batches of compounded drugs.
(e) The pharmacy shall maintain readily retrievable records of all compounded drugs ordered by practitioners for office use.
The records must be maintained for a minimum of two (4) years and shall include:
l. The name, address and phone number of the practitioner ordering the compounded drug for office use and the date of the
2. The name, strength. and quantity of the compounded drug provided, including the number of containers and quantity in
3. The date the drug was compounded;
4. The date the compounded drug was provided to the practitioner:
5. The Jot number and bevond use date.
(f) The pharmacy shall affix a label to any compounded drug that is provided for office use. The label shall include:
1. The name, address. and phone number of the compounding pharmacy:
2. The name and strength of the preparation of a list of active ingredients and strengths;
3. The phannacy's Jot nwnber and beyond-use-date;
4. The quantitv or amount in the container:
5. The appropriate ancillarv instructions such as storage instructions. cautionary statements. or hazardous drug warning
labels were appropriate; and
6. The statement "For Institutional or Office Use Only - Not for Resale." or if the drug is provided to a veterinarian the
statement "Compounded Drug."
Rulemaking ~Authority 465.005 FS. Law Implemented 465.003(12), 465.0155, 465.0265 FS. History-New 10-1-92, Formerly 21S-27.700,
6 1F J0-27.700, 59X-27.700, Amended 11-2-03, 10-7-08,__ ___ _

For complete PDJ with letter re: adoption click here

Tuesday, February 26, 2013

Reminder: Louisiana Board Meeting Tomorrow Feb. 27 to Discuss Patient-Specific or Office Use Prescriptions

2013-E ~ Amends the section of rules that allows pharmacies to prepare practitioner-administered compounds without a patient-specific prescription; specifically authorizes preparation of copies of commercial products when such products are unavailable; limits the amount of products that may be prepared by a pharmacy without a patient-specific prescription to ten percent of total products dispensed and distributed on an annual basis.
               01-23-2013 - Regulation Revision Committee approved Draft #1 (corrected).
               01-29-2013 - Draft #1 amended further.  Board adopted Declaration of Emergency and Emergency Rule with a stipulated effective date of January 31, 2013.
               01-30-2013 - Incorporated as Regulatory Project 2013-1.2.
 

2013-D ~ Repeals the sections of the rules that allow pharmacies to prepare practitioner-administered compounds without a patient-specific prescription.
               12-13-2012 - Board adopted Emergency Rule, with an immediate effective date.
               12-14-2012 - Incorporated as Regulatory Project 2013-1.1.
               01-18-2013 - Louisiana Senate Committee on Health and Welfare rejected the Emergency Rule.  The effect of that decision voided the Emergency Rule effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule reflecting a different balance of risk vs benefit within two weeks.
 
Source found here

Agenda
Louisiana Board of Pharmacy
3388 Brentwood Drive
Baton Rouge, Louisiana 70809-1700
www.pharmacy.la.gov
NOTICE IS HEREBY GIVEN that a Public Hearing has been ordered and called for
9:00 a.m. on Wednesday, February 27, 2013 at the Board office, for the purpose to wit:
A G E N D A
1. Call to Order
2. Appearances
3. Notice of Intent re Regulatory Project 2013-1 ~ Compounding for Prescriber’s Use
4. Notice of Intent re Regulatory Project 2013-2 ~ Satellite Pharmacies
5. Opportunity for Public Comment
6. Adjourn
 

Friday, February 8, 2013

South Dakota Board of Pharmacy's Position Regarding Office Use

MEDICATION REQUESTS FOR “OFFICE USE”
The board receives frequent advice from pharmacists related to prescription the pharmacy may receive from a prescriber indicating the “for office use” on the prescription. SDCL 36-11-2 (22) defines this. “Prescription drug order,” a written or oral order of a practitioner for a drug or drug device for a specific patient. Therefore, a prescription that is not patient specific is not valid. If a practitioner requests medication from a pharmacy, this transaction is considered a wholesale distribution. For non-controlled substances, the invoice must contain the name, strength, and dosage form of the medication, date of the transaction, name and address of the seller and the purchaser. For controlled substances, the record must contain all the information stated above, as well as the DEA numbers of the both the seller and the purchaser. If the medication is a CII controlled substance, the purchaser must execute a DEA Form 222 to the seller prior to the transaction. Records for controlled substance transaction must be maintained in a readily retrievable manner for a minimum of 2 years.  

Wednesday, February 6, 2013

Reminder of Public Hearing on Issue of Compounding for Prescriber's Use (Office Use) in Louisiana on Feb. 27, 2013

2013-1.1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D]
               12-13-2012     Board issued Declaration of Emgergency & Emergency Rule, effective immediately.
               12-16-2012     Distributed electronic Notice of Emergency Rule to all pharmacies, all pharmacists, and List of Interested Parties.
               12-17-2012     Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
               01-18-2013     Louisiana Senate Committee on Health and Welfare rejected the emergency rule.  The effect of that decision was to void the December 13, 2012 emergency rule, effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
               01-18-2013     Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to all pharmacies, all pharmacists, and List of Interested Parties.


2013-1 ~ Compounding for Prescriber's Use [Source: Regulatory Proposal 2013-D]
               01-20-2013     1st Report: Notice of Intent
               02-27-2013     Public Hearing

Wednesday, January 30, 2013

Update on Office Use in Louisiana: Review 1st Report and Note Public Hearing Scheduled

2013-1 ~ Compounding for Prescriber's Use (aka compounding for office use)               12-13-2012     Board issued Declaration of Emergency & Emergency Rule, effective immediately.
               12-16-2012     Distributed electronic Notice of Emergency Rule to List of Interested Parties, all pharmacies, and all pharmacists.
               12-17-2012     Distributed required Notice of Emergency to Office of the Governor, Office of the Attorney General, Office of the President of the Senate, Office of the Speaker of the House of Representatives, and Office of the Director of the Louisiana Register.
               01-18-2013     Louisiana Senate Committee on Health and Welfare rejected the Emergency Rule.  The effect of that decision was to void the December 13, 2012 Emergency Rule, effective immediately.  However, in recognition of the continuing potential risk, the legislative committee directed the Board to develop a replacement emergency rule with a different balance of risk vs benefit within two weeks.
               01-18-2013     Provided notice of legislative decision by distributing electronic Notice of Rulemaking Activity to List of Interested Parties, all pharmacies, and all pharmacists.
               01-20-2013     1st Report: Notice of Intent
               02-27-2013     Public Hearing


source found here

Tuesday, January 29, 2013

Repost: Are States That Are Doing Away With Office Use Having a Knew Jerk Reaction and Not Really Understanding Benefits and Need for Office Use

Office use is absolutely essential in a veterinary practice.  Ask any vet. Each state, that has a specific rule dealing with office use, has its own interpretation regarding what office use allows. Louisiana  passed an emergency order regarding office use.  A lot of states are amending their office use regulations and statutes in light of the meningitis outbreak.  However, is office use in the veterinary world really the problem?  Is it even the problem in the human side?  Aren't these states' overreacting and creating more confusion and possibly less compliance than pre-NECC outbreak.  Is this another example of where pharmacy is not pharmacy and there should be one set of pharmacy rules relating to compounds used to treat animals and one set for compounds used to treat humans?   Before states begin making changes or more specifically taking away office use shouldn't they contact and hear from those who understand the benefits and importance of office use?  What is the alternative if office use is not allowed ?  Is the alternative practical?  Pharmacists, the ones making, these decisions, about the rules, are not the ones who may know what is best in this area?  Being proactive does not mean having a knee-jerk reaction and doing something that is unworkable, unnecessary and does nothing to solve the problem that is the ultimate issue.

Saturday, January 19, 2013

Are States that Are Changing the Rules with Regard to Office Use of Compounds Having a Knee Jerk Reaction and Not Really Understanding the Benefits and Importance of Office Use?

Office use is absolutely essential in a veterinary practice.  Ask any vet. Each state, that has a specific rule dealing with office use, has its own interpretation regarding what office use allows. Louisiana  passed an emergency order regarding office use.  A lot of states are amending their office use regulations and statutes in light of the meningitis outbreak.  However, is office use in the veterinary world really the problem?  Is it even the problem in the human side?  Aren't these states' overreacting and creating more confusion and possibly less compliance than pre-NECC outbreak.  Is this another example of where pharmacy is not pharmacy and there should be one set of pharmacy rules relating to compounds used to treat animals and one set for compounds used to treat humans?   Before states begin making changes or more specifically taking away office use shouldn't they contact and hear from those who understand the benefits and importance of office use?  What is the alternative if office use is not allowed ?  Is the alternative practical?  Pharmacists, the ones making, these decisions, about the rules, are not the ones who may know what is best in this area?  Being proactive does not mean having a knee-jerk reaction and doing something that is unworkable, unnecessary and does nothing to solve the problem that is the ultimate issue.

Tuesday, December 4, 2012

Office Use in Kansas


Office Use Prescriptions
The Board has been asked on occasion whether
an “office use” prescription is valid. The answer is
no. Medications prescribed must be dispensed to a
patient. When medication is sent from a pharmacy to a
practitioner for administration, the transfer is considered
a distribution.
The transfer of a prescription medication is permitted
from one pharmacy to another pharmacy or practitioner.
The transfer must be documented with an invoice record.
The invoice record must have the name, strength, form of
the medication, the name and address of both the seller
and the purchaser, and the date of the sale. This record
should be maintained for five years with your pharmacy
records.
If the transfer is a controlled substance, the invoice
must also include the DEA number of both the seller
and the purchaser. If the medication is a Schedule II
medication, the purchaser must provide a DEA Form 222
to the seller before the transfer is completed.
A retail pharmacy may transfer prescription drugs to
another retail pharmacy to alleviate a temporary shortage,
except that the gross dollar value of these transfers
shall not exceed 5% of the total prescription-only drug
sales revenue of either the transferor or the transferee
pharmacy during any period of 12 consecutive months.
If a pharmacy is selling more than 5% they should be
registered as a wholesale distributor
Source found here

Saturday, November 17, 2012

No Office Use Allowed in Vermont


The November Newsletter of the Vermont Board of Pharmacy provides the following discussion:

‘Office Use’ Prescriptions
A recent question to the Board office asked whether
an “office use” prescription is valid. The answer is no.
Medications prescribed must be dispensed to a patient.
When medication is sent from a pharmacy to a practitioner
for administration, the transfer is actually a distribution.

The transfer of prescription medication is permitted
from one registrant (pharmacy) to another registrant
(pharmacy) or licensee (practitioner). Such transfer
must be documented by use of an invoice record. The
invoice record should have the name, strength, form of
the medication, the name and address of both the seller
and purchaser, and the date of sale. This invoice record
should be kept with other invoice records.
If the medication being transferred is a controlled substance
 (CS), there are additional invoice requirements.
The invoice record must also include the Drug Enforcement Administration
 (DEA) numbers of both the seller
and the purchaser.
If the medication is a Schedule II CS, the purchaser
must provide a DEA Form 222 to the seller before the
transfer is completed.
Sales of both non-CS and CS to other registrants and
practitioners should not exceed 5% of total sales during
any consecutive 12-month period.

Source found here

Saturday, November 3, 2012

IACP Law Library-Compounding for Office Use Available for Purchase


As part of our ongoing development of tools, programs and materials that help our members improve their professional and business practice, IACP is launching its IACP Law Library. As conceived, this law library will provide pharmacists with a comprehensive analysis of state pharmacy law and regulation that affect many day-to-day decisions.

Our first installment in the new IACP Law Library—Compounding for Office-Use is now available for purchase! Click here for purchase information.

Overview of Results
The majority of the states (42) allows pharmacies to sell any non-controlled prescription drug and compounded drugs to practitioners for office use. Six states specifically prohibit that activity, and two states appear to be silent. Silent means the statutes and regulations do not specifically say whether it’s allowed. As our phone calls to the states Boards revealed, silent does not necessarily mean it is not allowed. Many of the states Boards confirmed that although the statutes or regulations don't say office use is specifically permitted, the Boards allow by broad interpretation, board policy, or by common practice covered by a pharmacy’s license the provision of office-use prescriptions.
For the most part, those states that do specifically prohibit office-use prescriptions provide for a “sales” process instead and require that in lieu of a prescription, orders from practitioners must be placed via an invoice. Several of these states limit the amount of product that a pharmacy can sell to a practitioner for office use to either 5% of the total annual sales or 5% of the total dosages in a consecutive 12-month period. This five percent figure appears in many of the states controlled substances laws and is being applied by the Boards to sales for office use in general.
The percentage limitation is from the federal DEA Controlled Substances Act and rules. The five percent language was placed into some of the states PDMA laws – which deal with wholesaler licensure -- where the allowing of sales for office use also is found in an exemption provided in the definition of wholesale drug distribution. In these states, sales to practitioners are not wholesale drug distribution and do not require a wholesaler license. Many of the states providing the exemption limit the sales to 5%. If sales exceed 5%, then a pharmacy would be required to obtain a wholesale drug distributor license.
Unanswered Questions
Even the best research has limitations. Three states did not respond to our numerous phone calls and emails for clarifications and additional information. They are: Georgia, Illinois, and New Jersey.
  • Based on our review of the statutes and regulations, Georgia allows the sale to practitioners for legend drugs but is not clear as to whether such is allowed for compounded products.
  • Illinois and New Jersey allow the sale of compounded products for office use but appear to be silent as to whether legend drugs may be sold to a practitioner for office use.
IACP members doing business in those states should confer with the Board of Pharmacy if they have any questions.

To read entire IACP statement click here


Monday, September 24, 2012

Vermont Office Use Compounding


During the August 22, 2012, Vermont State Board of Pharmacy Meeting, the board discussed an email question regarding office use compounding.  Although the specific question was not provided in the minutes, here is the answer given:

h.  Istvan Nadas E-mail – Questions about Vermont office use compounding:

Question 1.  See rule  8.19, the cap cannot exceed 5% of total annual sales.  The alternative
would be for the veterinarian to write a script that can be filled at a pharmacy.  Also, see the
FDA’s good manufacturing rules.  Aprille will respond.

Question 2.  They have to be licensed in Vermont as an out of state pharmacy and abide by
Vermont Statutes and rules.  Aprille will respond.

Question 3.  See answer to number one.  Aprille will respond.

To see the entire board minutes click here.