Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, September 11, 2012
DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS for VETERINARIANS
DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS for VETERINARIANS relating to dispensing drugs provide:
2813. MANAGEMENT AND USE OF DRUGS
2813.1 A veterinarian shall prescribe, administer, or dispense drugs only for use on animals within the course of the veterinarian's professional practice. A veterinarian shall not prescribe drugs for use by humans.
2813.2 A veterinarian shall prescribe drugs only by a written prescription or on oral prescription to a pharmacist as authorized by, and in compliance with, applicable with, applicable District and federal laws and regulations.
2813.3 A written prescription shall have the following:
(a) Be signed by the prescribing veterinarian;
(b) Be dated on the day issued;
(c) Contain the full name and street address of the owner of the animal, the species of animal for which the drug is prescribed; and
(d) Contain the full name and street address of the veterinarian and the veterinarians's Drug Enforcement Administration number.
2813.4 Drugs may be administered only by a veterinarian or a veterinary assistant properly trained by a veterinarian in the manner of such administration of drugs and under the immediate direction of a veterinarian.
2813.5 A veterinarian shall retain the records required by this section for three (3) years and shall keep them separate from other records.
2813.6 The director may exempt holders of a special permit issued pursuant to § 2816 from the requirement of having a veterinarian administer or supervise the use of sodium pentobarbital.
2813.7 All drugs shall be dispensed by a veterinarian, or by a veterinary assistant pursuant to a prescription of a veterinarian. A veterinarian shall thoroughly inspect the prepared prescription and verify its accuracy in all respects.
2813.8 All drugs dispensed by a veterinarian shall be labeled with the following information:
(a) The name, address, and telephone number of the animal facility;
(b) The name and strength of the drug;
(c) The name of the client and animal identification;
(d) The date dispensed;
(e) Directions for use;
(f) The expiration date of the drug, where applicable; and
(g) The name of the prescribing veterinarian.
2813.9 All drugs dispensed by a veterinarian shall be in air-tight and light-resistant containers. All drugs dispensed by any veterinarian shall he in approved safety closure containers, unless the owner of the animal expressly requests that the medication not be provided in such containers.
2813.10 A veterinarian shall keep an account of all drugs prescribed, administered, or dispensed in the client record.
2813.11 A veterinarian shall keep controlled substances records separate from the client's other records and shall maintain them in chronological order for the administration, dispensing, or application of all Schedule II, III, IV and V drugs listed as part of the District of Columbia Uniform Controlled suhstances Act of 1981, D.C. Law 4-29, D.C. Code §§ 33-501 to 33-567. This record shall include the following:
(a) The date of transaction;
(b) The name of the drug and the amount dispensed or administered;
(c) The name of the client and animal identification; and
(d) The name of person administering, dispensing, or selling the drug.
2813.12 A veterinarian shall maintain invoices for all Schedule II, III, IV, and V drugs received on the premises where the stock of drugs is held, and shall keep invoices for schedule II drugs separate from other records. All records shall be maintained for a period of three (3) years from the date of a transaction.
2814. STORAGE AND INVENTORY OF DRUGS
2814.1 Drugs shall be stored in the following manner:
(a) Under conditions specified on the label of the original container, or as specified in the official veterinary medicine compendium;
(b) In accordance with applicable District and federal laws and regulations; and
(c) Under secure conditions so as to prevent theft or diversion.
2814.2 Drug storage areas shall he secure and temperature controlled and shall be kept clean and orderly.
2814.3 The stock of drugs and biologicals shall he reviewed at reasonable intervals so that working stock, at the time of expiration, are removed.
2814.4 A veterinarian shall take an inventory of all Schedule II, III, IV, and V drugs under the veterinarian's control every two (2) years and shall date and sign the inventory. The inventory shall indicate if it was made at the opening or closing of business and shall be kept on the premises where the drugs are stocked for three (3) years from the date of the inventory.
2814.5 A veterinarian shall keep Schedule II controlled substances in a locked area. Only a veterinarian shall have access to such drugs.
2814.6 A veterinarian shall immediately report the theft or unusual loss of Schedule II, III, IV or V controlled substances to the Department and the United States Drug Enforcement Administration. The Director shall make such forms available without charge to all veterinarians.
DISTRICT OF COLUMBIA MUNICIPAL REGULATIONS for VETERINARIANS is located here.
Monday, September 10, 2012
Delaware Laws Regarding the Practice of Veterinary Medicine
The statutes in Delaware provide as follow with regard to the practice of veterinary medicine:
Title 24 Professional Regulation of the Delaware Statutes
2.0 Unprofessional Conduct for
Veterinarians (24
Del.C. §3313(a)(1))
2.1 Unprofessional
conduct in the practice of veterinary medicine shall include, but not be limited
to, the following;
***
2.1.11 Improper labeling of prescription drugs. The package or label must contain
the following information, either typed or in legible
handwriting:
2.1.11.1 Name and
address of the prescribing veterinarian;
2.1.11.2 Patient's
first name and owner's last name;
2.1.11.3 Name,
strength and quantity of the drug, and date dispensed;
2.1.11.4 Specific
usage directions, describing the exact method by which the drug must be
administered. A prescription without specific directions, or a prescription
bearing the notation "as directed" without specific directions, may not be
prepared or dispensed.
2.1.12 Failure to
make childproof packaging available for prescription drugs upon the request of a
client.
***
2.1.15 Prescribing
medication without examining the animal(s) within a period of one
year.
Colorado Veterinary Statutes, Regulations and Policies Relating to Dispensing and Prescribing Drugs
Colorado Statutes 12-64-111. Discipline of licensees provide that:
(1) Upon receipt of a signed complaint by a complainant or upon its own motion, the board may proceed to a hearing in conformity with section 12-64-112. After a hearing, and by a concurrence of a majority of members, the board may deny a license to an applicant or revoke or suspend the license of, place on probation, or otherwise discipline or fine, a licensed veterinarian for any of the following reasons:
Colorado Regulations:
8. Prescription Drugs
Veterinarians may only prescribe medication when they have a VCPR with the patient. Under federal and state law, veterinarians may not sell, distribute, dispense or participate in or arrange for the sale of prescription medicines in any fashion except through a VCPR or in compliance with Rule V. Veterinarians are charged with knowledge of the pharmacy practice act provisions that apply to their practice, as well as the laws and regulations of the federal food and drug administration. When a client requests a copy of a prescription for their animal under current treatment, the veterinarian must provide it to the client.
RULE V. WAIVER OF VETERINARIAN-CLIENT-PATIENT RELATIONSHIP FOR ADMINISTERING, DISTRIBUTING, DISPENSING, OR PRESCRIBING IN AN EMERGENCY SITUATION ONLY
(Adopted November 3, 2011, Effective December 30, 2011)
A. If a licensed veterinarian who has an established veterinarian-client-patient relationship (VCPR) with a patient prescribes a prescription drug that the licensed veterinarian does not have in stock and is not available at a local pharmacy, then in an emergency situation ONLY another licensed veterinarian who does not have a VCPR with that same patient may administer, distribute, or dispense a prescription drug to that patient based on the examining veterinarian’s expertise and established VCPR with the patient as long as the following requirements are met:
1. The examining veterinarian with the VCPR must document the emergency and the immediate need for the prescription drug;
2. The examining veterinarian with the VCPR must document his or her efforts to obtain the prescription drug from a local pharmacy, including documentation of contact with at least 1 pharmacy in the general proximity of the examination location that does not have the prescription drug immediately available;
3. The examining veterinarian must provide a written prescription;
4. The examining veterinarian must have direct communication with the dispensing veterinarian; and
5. The licensed veterinarian who administers, distributes, or dispenses the prescription drug on behalf of the examining veterinarian must document the date the prescription is administered, distributed, or dispensed.
B. "Emergency" as defined in Rule I.C is limited in application to this rule
The regulations provide the following fines for the failure to provide a written prescription:
3. Failure to Provide a Written Prescription
a. $250 for the 1st violation
b. $500 for the 2nd violation
c. Up to $1,000 for the 3rd or subsequent violation
Colorado State Board of Veterinary Medicine
Policies & Guidelines Effective: June 2011
Page 8
Board Guideline Regarding Prescription Medications
The Colorado State Board of Veterinary Medicine believes that the appropriate prescribing, dispensing, and administration of prescription and other medications is a crucial element in the treatment of animal patients. Veterinarians should only prescribe medications for animals with which they have a veterinary-client-patient relationship. Veterinarians may dispense medications for the animals under their care. Should a client ask for a written prescription for an animal being seen by a veterinarian, the veterinarian should supply that written prescription, as it is a part of the animal’s medical record, and the owner has a right to that record pursuant to C.R.S. 12-64-120 (2003). However, at any time, if supplying the prescription would compromise or risk the animal’s health, the veterinarian should decline to provide it and inform the owner what is required in order to address the animal’s health concerns. Internet pharmacy sale of prescription medications is legal if the veterinarian involved has a valid client patient relationship with the animal for which he is supplying the medications. In addition, he must have prescribed an appropriate medication for that animal, which is always the case whether by internet or other means. Veterinarians are authorized providers under the law and may procure, store, and dispense whatever medications they prescribe for their patients. Whether or not internet business constitutes a “pharmacy” under state law is an issue for the Colorado State Board of Pharmacy to determine. The sale of nonprescription drugs in Colorado is largely unregulated. Internet pharmacy sale of such medications is legal, as is sales of these medications in any animal supply store.
(1) Upon receipt of a signed complaint by a complainant or upon its own motion, the board may proceed to a hearing in conformity with section 12-64-112. After a hearing, and by a concurrence of a majority of members, the board may deny a license to an applicant or revoke or suspend the license of, place on probation, or otherwise discipline or fine, a licensed veterinarian for any of the following reasons:
***
(aa) Administering, dispensing, distributing, or prescribing any prescription drug other than in the course of a veterinarian-client-patient relationship, except in accordance with section 12-64-104(2)(b);Colorado Regulations:
8. Prescription Drugs
Veterinarians may only prescribe medication when they have a VCPR with the patient. Under federal and state law, veterinarians may not sell, distribute, dispense or participate in or arrange for the sale of prescription medicines in any fashion except through a VCPR or in compliance with Rule V. Veterinarians are charged with knowledge of the pharmacy practice act provisions that apply to their practice, as well as the laws and regulations of the federal food and drug administration. When a client requests a copy of a prescription for their animal under current treatment, the veterinarian must provide it to the client.
RULE V. WAIVER OF VETERINARIAN-CLIENT-PATIENT RELATIONSHIP FOR ADMINISTERING, DISTRIBUTING, DISPENSING, OR PRESCRIBING IN AN EMERGENCY SITUATION ONLY
(Adopted November 3, 2011, Effective December 30, 2011)
A. If a licensed veterinarian who has an established veterinarian-client-patient relationship (VCPR) with a patient prescribes a prescription drug that the licensed veterinarian does not have in stock and is not available at a local pharmacy, then in an emergency situation ONLY another licensed veterinarian who does not have a VCPR with that same patient may administer, distribute, or dispense a prescription drug to that patient based on the examining veterinarian’s expertise and established VCPR with the patient as long as the following requirements are met:
1. The examining veterinarian with the VCPR must document the emergency and the immediate need for the prescription drug;
2. The examining veterinarian with the VCPR must document his or her efforts to obtain the prescription drug from a local pharmacy, including documentation of contact with at least 1 pharmacy in the general proximity of the examination location that does not have the prescription drug immediately available;
3. The examining veterinarian must provide a written prescription;
4. The examining veterinarian must have direct communication with the dispensing veterinarian; and
5. The licensed veterinarian who administers, distributes, or dispenses the prescription drug on behalf of the examining veterinarian must document the date the prescription is administered, distributed, or dispensed.
B. "Emergency" as defined in Rule I.C is limited in application to this rule
The regulations provide the following fines for the failure to provide a written prescription:
3. Failure to Provide a Written Prescription
a. $250 for the 1st violation
b. $500 for the 2nd violation
c. Up to $1,000 for the 3rd or subsequent violation
Colorado State Board of Veterinary Medicine
Policies & Guidelines Effective: June 2011
Page 8
Board Guideline Regarding Prescription Medications
The Colorado State Board of Veterinary Medicine believes that the appropriate prescribing, dispensing, and administration of prescription and other medications is a crucial element in the treatment of animal patients. Veterinarians should only prescribe medications for animals with which they have a veterinary-client-patient relationship. Veterinarians may dispense medications for the animals under their care. Should a client ask for a written prescription for an animal being seen by a veterinarian, the veterinarian should supply that written prescription, as it is a part of the animal’s medical record, and the owner has a right to that record pursuant to C.R.S. 12-64-120 (2003). However, at any time, if supplying the prescription would compromise or risk the animal’s health, the veterinarian should decline to provide it and inform the owner what is required in order to address the animal’s health concerns. Internet pharmacy sale of prescription medications is legal if the veterinarian involved has a valid client patient relationship with the animal for which he is supplying the medications. In addition, he must have prescribed an appropriate medication for that animal, which is always the case whether by internet or other means. Veterinarians are authorized providers under the law and may procure, store, and dispense whatever medications they prescribe for their patients. Whether or not internet business constitutes a “pharmacy” under state law is an issue for the Colorado State Board of Pharmacy to determine. The sale of nonprescription drugs in Colorado is largely unregulated. Internet pharmacy sale of such medications is legal, as is sales of these medications in any animal supply store.
Arkansas Board of Veterinary Medical Examiners Regulations Relating to Prescription Drugs and Controlled Substances
These regulations cover both prescription drugs and controlled substances. Regulation 10 provides:
All prescription drugs shall be stored, maintained, administered dispensed, sold or prescribed in compliance with federal and state laws. Veterinarians who dispense pharmaceuticals must comply with the following minimum standards for drug procedures:
A. Except for labeled manufactured drugs with proper instructions, all drugs dispensed shall be labeled with:
(1) Name, address and telephone number of the facility,
(2) Name of client,
(3) Animal Identification,
(4) Date dispensed,
(5) Directions for use,
(6) Name and Strength of Drug
(7) Quantity dispensed
(8) Name of the prescribing veterinarian, and
(9) The statement "For Veterinary Use Only",
B. A lay employee may count, fill and label a prescription under the direct order of the veterinarian according to specific instructions.
C. A record of all drugs administered or dispensed shall be kept in the records of the individual animal if the animal is a companion animal, or in the client's record if the animal is an economic animal.
D. Prescription drugs may not be purchased, advertised, displayed, sold or bartered by veterinarians except in the course of their professional practice. The fact that the individual is a veterinarian does not provide any exception which is not also available to non-veterinarians. Veterinarians who are in the employ of drug manufacturers or distributors and veterinarians who operate their own drug distributorship or sales outlets cannot legally sell prescription drugs or issue prescriptions for them outside the scope of a professional practice.
E. Practicing veterinarians and their employees cannot legally sell prescription drugs to walk-in customers unless a valid veterinarian/client/patient relationship exists. Prescription drugs may only be sold through a retail outlet, by mail order, a route salesman or other sales method on the written order (prescription) of a licenced veterinarian who has established a valid veterinarian/client/patient relationship and that written order (prescription is filled by a veterinarian or pharmacist currently licensed by the state of Arkansas.
Regulation 11 dealing with Controlled Substances provides:
All controlled substances shall be stored, maintained, administered, dispensed and prescrived in compliance with federal and state law.
A. Where dispensing or use of controlled substances takes place, an inventory must be conducted every two (20 years and kept as a separate part of your permanent record,
B. The form for keeping records of controlled substances shall contain the following information in addition to the name of the drug:
(1) Date of acquisition,
(2) Quantity purchased,
(3) Date administered, dispensed or prescribed,
(4) Quantity administered, dispensed or prescribed,
(5) Name and address of client and patient receiving the drug(s)
(6) Species of the animal,
(7) Name or initials of individual who dispensed or administered the drug, and
(8) Balance on hand.
C. Records for Schedule II substances must be kept separate from Schedule III, IV and V substances.
D. Inventories and records of narcotic drugs listed in Schedule I, II, III, IV and V shall be maintained separately from all other records or in such form that the information required is readily retrievable from ordinary business records or patient's records.
E. Every veterinarian who is permitted to dispense, distribute, administers or conduct research with respect to controlled substances in the course of professional practice or research in Arkansas shall obtain a registration from the Federal Drug Enforcement Administration, unless exempt by Law.
F. A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are maintained, manufactured, distributed, or dispensed.
G. All veterinarians shall provide effective controls and procedures to guard against theft and diversion of controlled substances. Controlled substances listed in Schedule I, II, III, IV and V shall be stored under double lock security in a vault or locking cabinet in a room with limited access.
H. Each veterinarian shall notify the Division of Pharmacy Services and Drug Control, Arkansas Department of Health, immediately upon discovery of any suspected loss, theft and/or diversion of any controlled substance.
I. All controlled substances that are no longer stable because of deterioration or expired dating or are unwanted, must be delivered in person or by registered mail or other means of shipment with return receipt to Division of Pharmacy Services & Drug Control, Arkansas Department of Health, and accompanied by all completed compiles of Report of Drugs Surrendered (Form PhA DC-1) furnished by the Health Department or may be destroyed only by authorized agents of the Arkansas State Board of Pharmacy or the Arkansas Department of Health on site.
J. The only drugs approved by this Board for pre-euthanasia of animals by a certified animal euthanasia technician in a facility approved by the AR Department of Health/Pharmacy Services and Drug Control shall be Acepromazine and Xylazine.
Regulations found here
All prescription drugs shall be stored, maintained, administered dispensed, sold or prescribed in compliance with federal and state laws. Veterinarians who dispense pharmaceuticals must comply with the following minimum standards for drug procedures:
A. Except for labeled manufactured drugs with proper instructions, all drugs dispensed shall be labeled with:
(1) Name, address and telephone number of the facility,
(2) Name of client,
(3) Animal Identification,
(4) Date dispensed,
(5) Directions for use,
(6) Name and Strength of Drug
(7) Quantity dispensed
(8) Name of the prescribing veterinarian, and
(9) The statement "For Veterinary Use Only",
B. A lay employee may count, fill and label a prescription under the direct order of the veterinarian according to specific instructions.
C. A record of all drugs administered or dispensed shall be kept in the records of the individual animal if the animal is a companion animal, or in the client's record if the animal is an economic animal.
D. Prescription drugs may not be purchased, advertised, displayed, sold or bartered by veterinarians except in the course of their professional practice. The fact that the individual is a veterinarian does not provide any exception which is not also available to non-veterinarians. Veterinarians who are in the employ of drug manufacturers or distributors and veterinarians who operate their own drug distributorship or sales outlets cannot legally sell prescription drugs or issue prescriptions for them outside the scope of a professional practice.
E. Practicing veterinarians and their employees cannot legally sell prescription drugs to walk-in customers unless a valid veterinarian/client/patient relationship exists. Prescription drugs may only be sold through a retail outlet, by mail order, a route salesman or other sales method on the written order (prescription) of a licenced veterinarian who has established a valid veterinarian/client/patient relationship and that written order (prescription is filled by a veterinarian or pharmacist currently licensed by the state of Arkansas.
Regulation 11 dealing with Controlled Substances provides:
All controlled substances shall be stored, maintained, administered, dispensed and prescrived in compliance with federal and state law.
A. Where dispensing or use of controlled substances takes place, an inventory must be conducted every two (20 years and kept as a separate part of your permanent record,
B. The form for keeping records of controlled substances shall contain the following information in addition to the name of the drug:
(1) Date of acquisition,
(2) Quantity purchased,
(3) Date administered, dispensed or prescribed,
(4) Quantity administered, dispensed or prescribed,
(5) Name and address of client and patient receiving the drug(s)
(6) Species of the animal,
(7) Name or initials of individual who dispensed or administered the drug, and
(8) Balance on hand.
C. Records for Schedule II substances must be kept separate from Schedule III, IV and V substances.
D. Inventories and records of narcotic drugs listed in Schedule I, II, III, IV and V shall be maintained separately from all other records or in such form that the information required is readily retrievable from ordinary business records or patient's records.
E. Every veterinarian who is permitted to dispense, distribute, administers or conduct research with respect to controlled substances in the course of professional practice or research in Arkansas shall obtain a registration from the Federal Drug Enforcement Administration, unless exempt by Law.
F. A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are maintained, manufactured, distributed, or dispensed.
G. All veterinarians shall provide effective controls and procedures to guard against theft and diversion of controlled substances. Controlled substances listed in Schedule I, II, III, IV and V shall be stored under double lock security in a vault or locking cabinet in a room with limited access.
H. Each veterinarian shall notify the Division of Pharmacy Services and Drug Control, Arkansas Department of Health, immediately upon discovery of any suspected loss, theft and/or diversion of any controlled substance.
I. All controlled substances that are no longer stable because of deterioration or expired dating or are unwanted, must be delivered in person or by registered mail or other means of shipment with return receipt to Division of Pharmacy Services & Drug Control, Arkansas Department of Health, and accompanied by all completed compiles of Report of Drugs Surrendered (Form PhA DC-1) furnished by the Health Department or may be destroyed only by authorized agents of the Arkansas State Board of Pharmacy or the Arkansas Department of Health on site.
J. The only drugs approved by this Board for pre-euthanasia of animals by a certified animal euthanasia technician in a facility approved by the AR Department of Health/Pharmacy Services and Drug Control shall be Acepromazine and Xylazine.
Regulations found here
Sun Pharma
Sun Pharma Says Things Are Improving, But…
1 Comment
By Ed Silverman // September 10th, 2012 // 10:54
am
Late last month, Sun Pharma happily declared that its Caraco
unit was finally in compliance with good manufacturing practices after receiving
notice from the FDA. This meant that two manufacturing and packaging facilities
in Michigan were able to resume limited operations after various inspections and
so-called 483 reports had been issued by the agency. Specifically, Caraco can
now resume production of just two products – Carvedilol USP and Paramomycin USP
“Manufacturing of other products from these sites, including those pending approval with the USFDA, will be subject to similar rigorous approval procedure. As a result, the increase in production at these sites and resultant revenue contribution is expected to be gradual,” the Indian drugmaker, whose unit had been operating under a 2009 consent decree, said in a statement. Regular inspections will, otherwise, continue for an extended period.
To read rest of this article click here
“Manufacturing of other products from these sites, including those pending approval with the USFDA, will be subject to similar rigorous approval procedure. As a result, the increase in production at these sites and resultant revenue contribution is expected to be gradual,” the Indian drugmaker, whose unit had been operating under a 2009 consent decree, said in a statement. Regular inspections will, otherwise, continue for an extended period.
To read rest of this article click here
FDA Office of Generic Drugs Is Being Elevated
For Those Of You Who Follow FDA Doings…
3
By Ed Silverman // September 10th, 2012 // 9:04
am
Watching the FDA may seem like so much ‘inside baseball’ to
the vast majority of people, but organizational changes can often have a
significant impact on how decisions are made, of course. So with this in mind,
we thought we would let you know about a few shifts inside the FDA’s Center for
Drug Evaluation and Research, which were announced late last week and are in the
process of being implemented.
Specifically, the Office of Generic Drugs is being elevated to a so-called ‘super office,’ which means the OGD will become an umbrella for other offices and report directly to CDER director Janet Woodcock. Other examples of ‘super offices’ include the Office of New Drugs and the Office of Surveillance and Epidemiology. OGD director Greg Geba will continue to head the office, according to the FDA announcement.
To read the rest of Ed Silverman's blog click here
Specifically, the Office of Generic Drugs is being elevated to a so-called ‘super office,’ which means the OGD will become an umbrella for other offices and report directly to CDER director Janet Woodcock. Other examples of ‘super offices’ include the Office of New Drugs and the Office of Surveillance and Epidemiology. OGD director Greg Geba will continue to head the office, according to the FDA announcement.
To read the rest of Ed Silverman's blog click here
Arkansas Veterinary Medical Examining Board Practice Act Relating to Prescription Drugs
ARKANSAS VETERINARY MEDICAL EXAMINING BOARD PRACTICE ACT
§17-101-305(a)(14) deals with the discipline of veterinarians in Arkansas who use, prescribe or sale veterinary prescription drugs without a valid veterinarian-client-patient relationship. That section provides as follows:
VETERINARIANS - DENIAL, SUSPENSION OR REVOCATION OF LICENSE
(a) Upon written complaint by any person or on the Board‟s own motion and after notice and hearing as prescribed in the Administrative Procedure Act (25-15-201 et. Seq.), the Board may deny, suspend for a definite period or revoke the license of any veterinarian and/or impose a civil penalty for:
***
(14) The use, prescription or sale of any veterinary prescription drug, or the prescription of an extra-label use of any over-the-counter drug in the absence of a valid veterinarian-client-patient relationship;
The Practice Act is found here.
The Practice Act is found here.
Sunday, September 9, 2012
Arizona Veterinary Board Compounding Answers
The Arizona Veterinary Medical Examining Board Scratching Post Newsletter dated February 2012 contained the following questions and answers regarding compounding:
This was submitted by an attorney that presented this Information to the Board at their December 21, 2011
meeting. The Board
has not adopted policies to
address or enforce these
interpretations.
This was submitted by an attorney that presented this Information to the Board at their December 21, 2011
Q: Why are some
pharmacies willing to sell
bulk compounds for
veterinary hospital dispensing and
others are
not?
A: The pharmacists
may not be aware that the
clinic is dispensing the
medications for clients to take
home, or the pharmacy may be
unfamiliar with the laws
governing this practice.
Q: What If I am not
reselling the compounded
medication, rather I am
providing the take-home portion of
a compounded medication
that was obtained from a
pharmacy free of charge?
A: Both reselling
and dispensing at no-fee
are restricted to the practice
of pharmacy in Arizona.
Q: Does this mean
that veterinarians must
write a prescription for
100% of the compounded
medications
used to treat
animals outside of the clinic?
A: Yes
Q: Does this mean
that veterinarians are
restricted from sending a small
quantity of compounded
medications home with the
patient to cover the period of
time between the patient’s visit
and the
pharmacy’s filling
of the prescription?
A: Yes
Q: What if my
practice works exclusively
with rescued animals that
are under foster care, can a
pharmacy
provide my practice
with pro-made compounded
medications to send to the
foster homes?
A: No. Even fostered
animals cared for
outside of the clinic or hospital
require the veterinarian to
arrange for a pharmacy to fill the
prescription.
Q: What If there is
an acute need for a
compounded medication and the
animal cannot wait?
A: Most specialty
pharmacies that provide
compounding services
understand these challenges and
provide emergency services. The
specialty pharmacies can also
arrange for delivery of
medications to rural areas, usually
within 24 hours. Collaborating
with a trained veterinary
pharmacy specialist can often
provide
the veterinarian
with several options during
emergency situations to
accommodate acute needs.
Q: Can the State of
Arizona update the
veterinary practice act to address this
issue?
A: The legislature
does a have process and the
power to expand the
veterinary practice to show
veterinarians more options as they
pertain to compounding
services.
COMPOUNDED
MEDICATIONS
FREQUENTLY ASKED
QUESTIONS
Arizona's Veterinary Administrative Rules Regarding Drug Dispensing
Arizona's Veterinary Administrative Rules, which should be read in conjunction with the statutes discussed in the previous blog, relating to drug dispensing have a requiring that the veterinarian notify the animal owner that some prescription-only drugs and controlled substances may be available at a pharmacy.
ARTICLE 8. DRUG DISPENSING
R3-11-801. Notification that Prescription-only Drugs or Controlled Substances May Be
Available at a Pharmacy
A. A dispensing veterinarian shall notify an animal owner that some prescription-only drugs and
controlled substances may be available at a pharmacy by:
1. Stating the availability at or before the time of dispensing;
2. Posting a written statement that is visible to the animal owner; or
3. Providing the animal owner with written notification.
B. A dispensing veterinarian may provide a written prescription to the animal owner if requested by
an animal owner.
R3-11-802. Labeling Requirements
A veterinarian shall dispense a prescription-only drug or a controlled substance in a container
bearing a legible label that sets forth all of the information in A.R.S. § 32-2281(A)(1), and the name
and telephone number of the veterinary medical premises from which the prescription-only drug or
controlled substance is dispensed.
R3-11-803. Packaging Requirements
A. A veterinarian shall dispense four ounces or less of a prescription-only drug in a childproof
container unless the animal owner waives this requirement.
B. A veterinarian shall dispense a controlled substance in a childproof container.
C. A veterinarian may dispense more than four ounces of a bulk prescription-only drug in a nonchildproof container.
D. A veterinarian may dispense a prescription-only drug in the manufacturer's original dispensing
package without repackaging the prescription-only drug in a childproof container.
R3-11-804. Reserved 28
R3-11-805. Storage
A. A dispensing veterinarian shall store controlled substances under lock and key except for
controlled substances that are authorized by a responsible veterinarian to be administered by
personnel.
B. A dispensing veterinarian shall store prescription-only drugs in an area to which members of the
public are not allowed access unless accompanied by a veterinarian or a member of the
veterinarian's staff.
C. A dispensing veterinarian shall store prescription-only drugs and prescription-only devices in
compliance with state and federal laws and in compliance with the manufacturer's requirements.
R3-11-806. Reserved
R3-11-807. Dispensing a Controlled Substance or Prescription-only Drug
A. When dispensing a controlled substance:
1. A dispensing veterinarian or personnel who are not veterinarians but who
are authorized by a veterinarian may:
a. Select the controlled substance,
b. Count the quantity of the controlled substance, and
c. Place the controlled substance in a prescription container.
2. Licensed or unlicensed personnel may:
a. Prepare labels,
b. Prepare drug containers for controlled substances, or
c. Record information required by state and federal laws.
3. A dispensing veterinarian shall review the label of a repackaged controlled substance and
the patient's medical record and ensure that the label complies with R3-11-502 and state and
federal laws before the controlled substance is dispensed.
B. When dispensing a prescription-only drug:
1. A dispensing veterinarian or personnel who are not veterinarians but who are
authorized by a veterinarian may:
a. Repackage prescription-only drugs,
b. Prepare labels,
c. Prepare containers for prescription-only drugs, or
d. Record information required by state or federal laws.
2. The dispensing veterinarian authorizing the dispensing shall ensure that records are
maintained according to R3-11-502(K) and R3-11-502(L) and all state and federal laws are
followed.
These statutes can be found here.
ARTICLE 8. DRUG DISPENSING
R3-11-801. Notification that Prescription-only Drugs or Controlled Substances May Be
Available at a Pharmacy
A. A dispensing veterinarian shall notify an animal owner that some prescription-only drugs and
controlled substances may be available at a pharmacy by:
1. Stating the availability at or before the time of dispensing;
2. Posting a written statement that is visible to the animal owner; or
3. Providing the animal owner with written notification.
B. A dispensing veterinarian may provide a written prescription to the animal owner if requested by
an animal owner.
R3-11-802. Labeling Requirements
A veterinarian shall dispense a prescription-only drug or a controlled substance in a container
bearing a legible label that sets forth all of the information in A.R.S. § 32-2281(A)(1), and the name
and telephone number of the veterinary medical premises from which the prescription-only drug or
controlled substance is dispensed.
R3-11-803. Packaging Requirements
A. A veterinarian shall dispense four ounces or less of a prescription-only drug in a childproof
container unless the animal owner waives this requirement.
B. A veterinarian shall dispense a controlled substance in a childproof container.
C. A veterinarian may dispense more than four ounces of a bulk prescription-only drug in a nonchildproof container.
D. A veterinarian may dispense a prescription-only drug in the manufacturer's original dispensing
package without repackaging the prescription-only drug in a childproof container.
R3-11-804. Reserved 28
R3-11-805. Storage
A. A dispensing veterinarian shall store controlled substances under lock and key except for
controlled substances that are authorized by a responsible veterinarian to be administered by
personnel.
B. A dispensing veterinarian shall store prescription-only drugs in an area to which members of the
public are not allowed access unless accompanied by a veterinarian or a member of the
veterinarian's staff.
C. A dispensing veterinarian shall store prescription-only drugs and prescription-only devices in
compliance with state and federal laws and in compliance with the manufacturer's requirements.
R3-11-806. Reserved
R3-11-807. Dispensing a Controlled Substance or Prescription-only Drug
A. When dispensing a controlled substance:
1. A dispensing veterinarian or personnel who are not veterinarians but who
are authorized by a veterinarian may:
a. Select the controlled substance,
b. Count the quantity of the controlled substance, and
c. Place the controlled substance in a prescription container.
2. Licensed or unlicensed personnel may:
a. Prepare labels,
b. Prepare drug containers for controlled substances, or
c. Record information required by state and federal laws.
3. A dispensing veterinarian shall review the label of a repackaged controlled substance and
the patient's medical record and ensure that the label complies with R3-11-502 and state and
federal laws before the controlled substance is dispensed.
B. When dispensing a prescription-only drug:
1. A dispensing veterinarian or personnel who are not veterinarians but who are
authorized by a veterinarian may:
a. Repackage prescription-only drugs,
b. Prepare labels,
c. Prepare containers for prescription-only drugs, or
d. Record information required by state or federal laws.
2. The dispensing veterinarian authorizing the dispensing shall ensure that records are
maintained according to R3-11-502(K) and R3-11-502(L) and all state and federal laws are
followed.
These statutes can be found here.
Arizona's Veterinary Medical Examining Board Statute Regarding Dispensing of Drugs and Devices
Arizona's veterinary statute regarding dispensing of drugs and devices provides:
Article 7 Dispensing of drugs and devices
32-2281. Dispensing of drugs and devices; conditions; definition
A. A veterinarian may dispense drugs and devices kept by the veterinarian if:
1. All prescription-only drugs are dispensed in packages labeled with the following
information:
(a) The dispensing veterinarian's name, address and telephone number.
(b) The date the drug is dispensed.
(c) The animal owner's name and the animal's or herd's identification.
(d) The name, strength and quantity of the drug, directions for its use and any
cautionary statements.
2. The dispensing veterinarian enters into the medical record the name, strength and
quantity of the drug dispensed, the date the drug is dispensed and the therapeutic
reason.
B. The Board shall adopt rules providing that the animal's owner or the person responsible
for the animal shall be notified that some prescription-only drugs may be available at a
pharmacy and a written prescription may be provided to the animal's owner or the person
responsible for the animal if requested.
C. A veterinarian shall dispense only to the animal's owner or person responsible for the
animal he is treating and only for conditions being treated by that veterinarian. The
veterinarian shall supervise the dispensing process. In this subsection, "supervision" means
that a veterinarian makes the determination as to the legitimacy or the advisability of the drugs
or devices to be dispensed.
D. This section shall be enforced by the Board which shall establish rules regarding access
to, labeling, record keeping, storage and packaging of drugs that are consistent with the
requirements of chapter 18 of this title. The Board may conduct periodic inspections of
dispensing practices to assure compliance with this section and applicable rules.
E. For the purposes of this section, "dispense" means the delivery by a veterinarian of a
prescription-only drug or device to an animal, an animal's owner or the person responsible for
an animal and includes the prescribing, administering, packaging, labeling and security
necessary to prepare and safeguard the drug or device for delivery.
The statute can be found here.
Article 7 Dispensing of drugs and devices
32-2281. Dispensing of drugs and devices; conditions; definition
A. A veterinarian may dispense drugs and devices kept by the veterinarian if:
1. All prescription-only drugs are dispensed in packages labeled with the following
information:
(a) The dispensing veterinarian's name, address and telephone number.
(b) The date the drug is dispensed.
(c) The animal owner's name and the animal's or herd's identification.
(d) The name, strength and quantity of the drug, directions for its use and any
cautionary statements.
2. The dispensing veterinarian enters into the medical record the name, strength and
quantity of the drug dispensed, the date the drug is dispensed and the therapeutic
reason.
B. The Board shall adopt rules providing that the animal's owner or the person responsible
for the animal shall be notified that some prescription-only drugs may be available at a
pharmacy and a written prescription may be provided to the animal's owner or the person
responsible for the animal if requested.
C. A veterinarian shall dispense only to the animal's owner or person responsible for the
animal he is treating and only for conditions being treated by that veterinarian. The
veterinarian shall supervise the dispensing process. In this subsection, "supervision" means
that a veterinarian makes the determination as to the legitimacy or the advisability of the drugs
or devices to be dispensed.
D. This section shall be enforced by the Board which shall establish rules regarding access
to, labeling, record keeping, storage and packaging of drugs that are consistent with the
requirements of chapter 18 of this title. The Board may conduct periodic inspections of
dispensing practices to assure compliance with this section and applicable rules.
E. For the purposes of this section, "dispense" means the delivery by a veterinarian of a
prescription-only drug or device to an animal, an animal's owner or the person responsible for
an animal and includes the prescribing, administering, packaging, labeling and security
necessary to prepare and safeguard the drug or device for delivery.
The statute can be found here.
Alaska's VeterinaryMedical Examining Board Statute Regarding Prescription Labeling
Alaska's veterinary statute provides the following with regard to labeling:
12 AAC 68.900. PRESCRIPTION LABELING. (a) All drugs prescribed and dispensed by a veterinarian for patient treatment must be labeled at the time of dispensing.
(b) The prescription label, or unit dosage package, must contain
(1) name of the owner of the patient;
(2) name of the prescribing veterinarian;
(3) name of the drug;
(4) strength and quantity of the drug;
(5) date dispensed;
(6) name and address of the veterinary facility dispensing the drug; and
(7) directions for the owner administering the drug to the patient.
12 AAC 68.900. PRESCRIPTION LABELING. (a) All drugs prescribed and dispensed by a veterinarian for patient treatment must be labeled at the time of dispensing.
(b) The prescription label, or unit dosage package, must contain
(1) name of the owner of the patient;
(2) name of the prescribing veterinarian;
(3) name of the drug;
(4) strength and quantity of the drug;
(5) date dispensed;
(6) name and address of the veterinary facility dispensing the drug; and
(7) directions for the owner administering the drug to the patient.
Alabama Veterinary Rules Regarding Prescribing and Dispensing Drugs
On the blog we will start taking a look at specific state laws and regulations regarding the prescribing and dispensing of animal drugs. First we will look at Alabama's laws. They currently have proposed changes that can be found here. A hearing is scheduled for October 10, 2012. The rules related to prescribing and dispensing drugs with changes red lined are below:
patient-veterinarian veterinary-client-patient relationship, or as defined by
the United States Food and Drug Administration.
(5) To protect children from serious personal injury or serious illness resulting from handling, using, or
ingesting controlled substances, legend drugs and other potentially harmful medicinal agents dispensed for animal use that is in a dosage form intended for oral administration shall be dispensed in childproof containers by all practitioners of veterinary medicine. The containers are to be designed and constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein.
Veterinary-client-patient relationship as used in this rule shall be defined as a relationship created by actual examination by the veterinarian of the annual or a representative segment of a consignment or herd.
RULE NUMBER: 930-X-1-.10
TITLE OF RULE: RULES OF PROFESSIONAL CONDUCT / GROUNDS OF DISCIPLINE
(20) Upon complaint and within its discretion, the Board may revoke or suspend the license of or otherwise discipline any licensed veterinarian under this rule. Grounds for disciplinary action shall include, but not be limited to, the following:
(ii) Providing veterinary drugs and medicines for resale to veterinary practitioners and other
veterinary wholesalers without a Wholesale Veterinary Drug Distributor’s permit issued by the
Alabama Board of Pharmacy.
RULE NUMBER: 930-X-1-.11
TITLE OF RULE: PRESCRIBING AND DISPENSING DRUGS.
(1) A licensed
veterinarian shall not prescribe or dispense, deliver or ordered delivered:
(a) Any drug or medicinal agent carrying the
legend “Federal (USFDA) law restricts this drug to the use by or on the order
of a licensed veterinarian” to be administered to animals with which he or she
has not established a
(b) Any controlled substance as defined by the
U.S. Food and Drug Administration without first having established a
patient-veterinarian veterinary-client-patient relationship
(2) Patient-veterinarian veterinary-client-patient
relationship by having personally established the individual animal,
herd or representative segment or consignment lot thereof and determined that
such controlled substance
is therapeutically indicated following said examination.
(3) Any veterinarian who violates this rule shall be guilty of unprofessional conduct within the meaning of this section.
(4) Veterinarians retiring from or otherwise discontinuing the practice of veterinary medicine shall voluntarily surrender their Alabama State Controlled Substance Registration Number immediately and shall notify the Federal Drug Enforcement Agency of license status change, retirement or discontinuance of practice for instructions regarding their federal DEA Registration.
(5) To protect children from serious personal injury or serious illness resulting from handling, using, or
ingesting controlled substances, legend drugs and other potentially harmful medicinal agents dispensed for animal use that is in a dosage form intended for oral administration shall be dispensed in childproof containers by all practitioners of veterinary medicine. The containers are to be designed and constructed to be significantly difficult for children under 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein.
(6) All
veterinarians must comply with Prescription Drug Monitoring Program (PDMP)
requirements.
(7) All
veterinarians providing veterinary drugs and medicines for resale to veterinary
practitioners and other
veterinary
wholesalers must obtain an Alabama Board of Pharmacy’s Wholesale Veterinary
Drug Distributor’s Permit. Veterinary-client-patient relationship as used in this rule shall be defined as a relationship created by actual examination by the veterinarian of the annual or a representative segment of a consignment or herd.
Author: Alabama State Board of Veterinary Medical
Examiners
Statutory Authority:
Code of Alabama 1975, §34-29-69RULE NUMBER: 930-X-1-.10
TITLE OF RULE: RULES OF PROFESSIONAL CONDUCT / GROUNDS OF DISCIPLINE
***
(20) Upon complaint and within its discretion, the Board may revoke or suspend the license of or otherwise discipline any licensed veterinarian under this rule. Grounds for disciplinary action shall include, but not be limited to, the following:
***
(ii) Providing veterinary drugs and medicines for resale to veterinary practitioners and other
veterinary wholesalers without a Wholesale Veterinary Drug Distributor’s permit issued by the
Alabama Board of Pharmacy.
FDA's Position on Compounding of Animal Drugs
Although this has been posted on the blog before, it is always worth reposting for new readers:
Compounding of Animal Drugs
In general, compounding an animal drug from an active pharmaceutical ingredient (bulk drug) is not permitted by the Act unless covered by an approved new animal drug application. This is true even if the compounder is a veterinarian or a pharmacist. However, CVM acknowledges the medical need for compounding may exist within certain areas of veterinary practice. The contemporary practice of veterinary medicine requires products to treat hundreds of conditions and diseases in dozens of species. Consequently, veterinarians continue to require products to treat diseases or conditions in animals for which no FDA-approved product is available. Generally, FDA will defer to state authorities regarding the day-to-day regulation of compounding by veterinarians and pharmacists of animal drugs. In limited circumstances, the agency may not object to compounding from specific bulk drugs under specific conditions. However, FDA will consider enforcement action when the activities of veterinarians and pharmacists are clearly outside the bounds of traditional pharmacy practice and are instead more akin to those of a drug manufacturer. Additional information on the FDA policy regarding animal drug compounding can be found in Compliance Policy Guide, Section 608.400, “Compounding of Drugs for Use in Animals."
Animal drugs may be legally compounded from FDA-approved animal drugs and FDA-approved human drugs if the compounding practices are in conformance with the provisions of the regulation on the Extra-label Use of FDA-approved drugs.
Quoted from FDA website found here.
The FDA's Position on Dispensing Veterinary Prescription Drugs and Labeling and Script Requirements
Dispensing Veterinary Prescription Drugs
Since adequate directions for safe and effective lay use cannot be written for animal prescription drug products, such products can only be sold on the prescription or other order of a licensed veterinarian (Section 503(f)). Prior to being sold or dispensed, they must remain in the possession of a person or firm regularly and lawfully engaged in the manufacture, transportation, storage, or wholesale or retail distribution of animal prescription drug products. The drug products may be distributed only by persons or firms authorized by State and local laws.
Sale (dispensing, shipping, or otherwise making available for use in animals) of an animal prescription drug product to the layperson may be made only by or on the bona fide prescription or other order of a licensed veterinarian. Sale of a animal prescription drug product to a layperson, except on a prescription or on order of a licensed practitioner, causes the product to be misbranded and subjects the seller to civil and/or criminal provisions of the Act.
A licensed veterinarian may legally use or dispense an animal prescription drug product only within the course of his/her professional practice where a valid veterinarian-client-patient relationship exists. Veterinarians employed by drug manufacturers or distributors may not legally dispense prescription drug products to laypersons unless they meet the above criteria. Similarly, practicing veterinarians or their employees may not legally sell animal prescription drug products to walk-in customers unless the same criteria are met. Federal regulations require that drug manufacturers provide at least the following information on the label of the finished package form of animal prescription drug products:
What information needs to be on the package label of animal Rx drugs?
- the statement, "Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian;"
- recommended or usual dosage;
- route of administration, if it is not for oral use;
- quantity or proportion of each active ingredient as well as the information required by section 502(e) of the Act;
- names of inactive ingredients if it is for other than oral use;
- an identifying lot or control number from which it is possible to determine the complete manufacturing history of the drug.
What needs to be included in the veterinarian’s prescription and included on the label of the dispensed product?
- name and address of the dispenser;
- serial number and date of the order or its filling;
- name and address of the veterinarian who prescribed or ordered the drug product;
- directions for use; and
- any necessary warning and precautionary statements including withdrawal times.
Any additional requirements of State or local laws for dispensed animal drug products must also be followed.
To protect themselves and their clients, veterinarians should make efforts to ensure their instructions are followed, especially when they prescribe or recommend drugs for food-producing animals that require a withdrawal period.
AAEP's 58th Annual Convention
The AAEP's 58th Annual Convention, See It All: Deeper Insights Into Equine Medicine will be held December 1-5, 2012 in Anaheim, California. There are a number of topics during this convention, but listed below are a few:
Ethics, Scope of Practice, and Racing
Moderator: Reynolds Cowles, Jr.
Sponsored by Merial, maker of GASTROGARD® (omeprazole).
Ethics, Scope of Practice, and Racing
Moderator: Reynolds Cowles, Jr.
Sponsored by Merial, maker of GASTROGARD® (omeprazole).
| 1:30 | Regulation of Veterinary Medicine – Stephen S. Galloway |
| 1:55 | Decisions That Matter: The Complementary Roles of Law, Morals, and Ethics in Equine Practice – F. Richard Lesser |
| 2:20 | Addressing the Ethical Challenges of Veterinary Practice in a Pari-Mutuel Environment – Scott E. Palmer |
| 2:40 | Ethical Issues for the Racetrack Practitioner: A Daily Requirement – Jeff A. Blea |
| 3:00 | VCPR: Racing – Jeff A. Blea; Sport Horse/Surgery/Ambulatory – Karen A. Nyrop; Pleasure/Broodmare – F. Richard Lesser;VCPR Overview - Harry W. Werner |
| 3:20 | Panel for Case-Based Discussion Moderator: Reynolds Cowles, Jr. Panelists: Jeff A. Blea, Stephen S. Galloway, F. Richard Lesser, Karen A. Nyrop, Scott E. Palmer, and Kim Volle For more information and to view registration, click here. |
Saturday, September 8, 2012
Compliance with USP Standards for Media-fill testing is required in Virginia
Compliance with USP Standards for
Compounding
Media-fill testing is required when performing low, medium,
and high-risk level compounding of compounded sterile preparations
(CSPs). USP35-NF30 states:
Media-Fill Test Procedure – This test or an equivalent
test is performed at least annually by each person
authorized to compound in a low-risk level environment
under conditions that closely simulate the most
challenging or stressful conditions encountered during
compounding of low-risk level CSPs. Once begun,
this test is completed without interruption. Quality
assurance procedures for medium-risk level CSPs
include all those for low-risk level CSPs, as well as
a more challenging media-fill test passed annually
or more frequently. In addition, a media-fill test that
represents high-risk level compounding is performed
semiannually by each person authorized to compound
high-risk level CSPs.
On June 12, 2012, the Board approved changes to Guidance
Document 110-36. The terms “annually” and “semiannually”
as used in United States Pharmacopeia (USP) Chapters 795 and
797 are defined to mean every 12 months and every six months,
respectively. Records associated with annual and semiannual
requirements shall be maintained for two years from the date
performed. Such records may be maintained in off-site storage
or as an electronic image that provides an exact image of the
document that is clearly legible provided such off-site or electronic
storage is retrievable and made available for inspection or
audit within 48 hours of a request by the Board or an authorized
agent. Board of Pharmacy guidance documents are available at
www.dhp.virginia.gov/Pharmacy/pharmacy_guidelines.htm.
Compounding
Media-fill testing is required when performing low, medium,
and high-risk level compounding of compounded sterile preparations
(CSPs). USP35-NF30 states:
Media-Fill Test Procedure – This test or an equivalent
test is performed at least annually by each person
authorized to compound in a low-risk level environment
under conditions that closely simulate the most
challenging or stressful conditions encountered during
compounding of low-risk level CSPs. Once begun,
this test is completed without interruption. Quality
assurance procedures for medium-risk level CSPs
include all those for low-risk level CSPs, as well as
a more challenging media-fill test passed annually
or more frequently. In addition, a media-fill test that
represents high-risk level compounding is performed
semiannually by each person authorized to compound
high-risk level CSPs.
On June 12, 2012, the Board approved changes to Guidance
Document 110-36. The terms “annually” and “semiannually”
as used in United States Pharmacopeia (USP) Chapters 795 and
797 are defined to mean every 12 months and every six months,
respectively. Records associated with annual and semiannual
requirements shall be maintained for two years from the date
performed. Such records may be maintained in off-site storage
or as an electronic image that provides an exact image of the
document that is clearly legible provided such off-site or electronic
storage is retrievable and made available for inspection or
audit within 48 hours of a request by the Board or an authorized
agent. Board of Pharmacy guidance documents are available at
www.dhp.virginia.gov/Pharmacy/pharmacy_guidelines.htm.
New Compounding Rules Will Be Effective in January 2015 in North Dakota
Pharmacy Inspections
It is the time of the year for pharmacy inspections to occur. By the time this Newsletter gets to you, inspections for most pharmacies will be complete. For those of you still waiting, as a reminder, the emphasis of the inspections this year will include:
♦ Use and compliance of Prescription Drug Monitoring Program
♦ Counseling or offer to counsel on all prescriptions by the pharmacist
♦ CII controlled substance audit: one done before the inspector arrives
and one during inspection
♦ Information on new hospital first dose review rule effective June
2015
♦ Information on new compounding rules effective January 2015
Taken from the September 2012 Newsletter found here.
These are the rules that must be complied with by 2015 here.
It is the time of the year for pharmacy inspections to occur. By the time this Newsletter gets to you, inspections for most pharmacies will be complete. For those of you still waiting, as a reminder, the emphasis of the inspections this year will include:
♦ Use and compliance of Prescription Drug Monitoring Program
♦ Counseling or offer to counsel on all prescriptions by the pharmacist
♦ CII controlled substance audit: one done before the inspector arrives
and one during inspection
♦ Information on new hospital first dose review rule effective June
2015
♦ Information on new compounding rules effective January 2015
Taken from the September 2012 Newsletter found here.
These are the rules that must be complied with by 2015 here.
New Mexico Board of Pharmacy is Considering Amendment to Dangerous Veterinary Drugs-Retail Distribution
New Jersey Board of Pharmacy Takes AVMA Letter as Informational Only
The July 2012 New Jersey Board of Pharmacy meeting minutes contain the following entry:
American Veterinary Medical Association - Consulting Veterinarians on appropriate prescription choices for their animal patients. The Board reviewed and discussed the letter. Since there were no specific accusations, the Board accepted this as informational only.
New Hampshire Board of Pharmacy Takes Letter From AVMA Letter Under Advisement
During August 15, 2012, New Hampshire Board of Pharmacy meeting, the board took under advisement the American Veterinary Medical Association (AVMA) Letter to Board President
Manoukian. See agenda here. It appears that these letters from the AVMA went out to a number if not all the state boards of pharmacy.
Manoukian. See agenda here. It appears that these letters from the AVMA went out to a number if not all the state boards of pharmacy.
NPI Number and Veterinarians in Nevada
From the Nevada Board of Pharmacy Newsletter found here.
NPI Number and Veterinarians
It has been reported to the Nevada State Board of Pharmacy that some pharmacies are refusing to fill prescriptions written by a veterinarian simply because the veterinarian has no National Provider Identifier (NPI) number. Please be aware that a veterinarian is not required to obtain an NPI number. The NPI number applies only to health care providers covered under Health Insurance
Portability and Accountability Act who bill Medicare. Obviously, veterinarians are not billing Medicare!
NPI Number and Veterinarians
It has been reported to the Nevada State Board of Pharmacy that some pharmacies are refusing to fill prescriptions written by a veterinarian simply because the veterinarian has no National Provider Identifier (NPI) number. Please be aware that a veterinarian is not required to obtain an NPI number. The NPI number applies only to health care providers covered under Health Insurance
Portability and Accountability Act who bill Medicare. Obviously, veterinarians are not billing Medicare!
Maine Board of Pharmacy Agrees to Work On Role of Pharmacists in The Dispensing of Pet Medication
The Maine Board of Pharmacy during its August 2, 2012 meeting agreed the pharmacy board would collaborate with the American Veterinary Medical Association regarding the roles of pharmacists in the dispensing of pet medication. This was based on a letter dated June 29, 2012, from Rene Carlson of the American Veterinary Medical Association. The minutes from this meeting can be viewed here
Kansas Board of Pharmacy to Discuss Dispensing of Animal Prescriptions
The Kansas Board of Pharmacy is scheduled to discuss the dispensing of animal prescriptions during its September 13-14, 2012 board meeting. This topic is currently on the agenda to be discussed on September 13th at 2:20. The agenda can be found here.
Kansas Board of Pharmacy Disciplinary Records
Kansas Board of Pharmacy disciplinary records for both pharmacies and pharmacists can be viewed here.
Deleware Board of Pharmacy Disciplinary Records
The Deleware Board of Pharmacy disciplinary records can be found here.
Colorado Board of Pharmacy Disciplinary Action
The Colorado Board of Pharmacy Disciplinary Action can be viewed here. The actions are arranged by month and year.
Arizona Board of Pharmacist Disciplinary Action
The Arizona Board of Pharmacy has its disciplinary actions located here. The website is easy to use if you know the name of the pharmacist who was disciplined or the case number of the action.
FDA Issues Warning Letter to Eli Lilly and Company Regarding Imaging Compound Amyvid
On Sept. 6, 2012, the FDA issued a letter sent to Eli Lilly and Company regarding a web page for PET imaging compound Amyvid. The letter reads:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration Silver Spring, MD 20993
Josephine Secnik, MS, MBA Director, Global Regulatory Affairs– U.S. Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285
RE: NDA #202008
Amyvid™ (Florbetapir F 18 Injection) for intravenous use
MA #9
Dear Ms. Secnik:
As part of its routine monitoring and surveillance program, the Office of Prescription Drug Promotion (OPDP), Division of Professional Drug Promotion (DPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a webpage (AM77988) for Amyvid™ (Florbetapir F 18 Injection) (Amyvid), submitted by Eli Lilly and Company’s (Eli Lilly) under cover of Form FDA-2253. This webpage includes a misleading multi-colored image of the brain. Additionally, OPDP has been made aware that these misleading images appeared in the commercial exhibit hall of the American Academy of Neurology annual meeting held in New Orleans, Louisiana on April 23-26, 2012. OPDP has determined that the materials misbrand Amyvid in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(a) & (n). See 21 CFR 202.1(e)(6)(xviii).
Background
Below are the indication and summary of the most serious and common risks associated with the use of Amyvid.1 According to the INDICATIONS AND USAGE section of the FDA-approved product labeling (PI):
Amyvid is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scanresult reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.
1 This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional piece cited in this letter.
Limitations of Use:
• A positive Amyvid scan does not establish a diagnosis of AD or other cognitive
disorder.
• Safety and effectiveness of Amyvid have not been established for:
o Predicting development of dementia or other neurologiccondition;
o Monitoring responses to therapies.
The PI for Amyvid contains Warnings and Precautions regarding the risk of image
misinterpretation and other errors as well as the risk of radiation exposure. In addition,
according to the ADVERSE REACTIONS section of the PI, the most commonly reported
adverse reactions include headache, musculoskeletal pain, fatigue, and nausea.
Misleading Presentation
The Amyvid webpage features a multi-colored brain image. This presentation misleadingly
suggests that Amyvid PET images can be displayed, and therefore interpreted, in color in
patients with cognitive impairment who are being evaluated for Alzheimer’s Disease and
other causes of cognitive decline, when this is not the case. According to the DOSAGE AND
ADMINISTRATION section of the PI, Amyvid PET scans should be displayed and reviewed
“using a black-white scale with the maximum intensity of the scale set to the maximum
intensity of all the brain pixels.” The PI further includes several examples of black and white
scans to illustrate proper image interpretation.
While many PET images are displayed and reviewed in color, Amyvid scans, as described
above, must be displayed and reviewed using a black and white scale. Additionally, the PI
does not provide instructions for estimating β-amyloid neuritic plaque density using a color
scale with Amyvid. Therefore, use of the color PET scan image of a brain in Amyvid
promotional materials is misleading, particularly considering the warning regarding the risk for
image misinterpretation and other errors.
Conclusion and Requested Action
For the reasons discussed above, this webpage misbrands Amyvid in violation of the FD&C
Act, 21 U.S.C. 352(a) & (n). See 21 CFR 202.1(e)(6)(xviii).
(b) (4)
Please direct your response to the undersigned at the Food and Drug Administration,
Center for Drug Evaluation and Research, Office of Prescription Drug Promotion,
Division of Professional Drug Promotion, 5901-B Ammendale Road, Beltsville,
Reference ID: 3173022
Josephine Secnik Page 3 Eli Lilly and Company NDA 202008/MA #9
Maryland 20705-1266 or by facsimile at (301) 847-8444. Please note that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has been reorganized and elevated to the Office of Prescription Drug Promotion (OPDP). OPDP consists of the Immediate Office, the Division of Professional Drug Promotion (DPDP) and the Division of Consumer Drug Promotion (DCDP). To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. In addition, OPDP recently migrated to a different tracking system. Therefore, OPDP letters will now refer to MA numbers instead of MACMIS numbers. Please refer to MA # 9 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Amyvid comply with each applicable requirement of the FD&C Act and FDA implementing regulations.
Sincerely,
{See appended electronic signature page}
James S. Dvorsky, PharmD Regulatory Review Officer Division of Professional Drug Promotion Office of Prescription Drug Promotion
{See appended electronic signature page}
Andrew S.T. Haffer, PharmD Acting Director Division of Professional Drug Promotion Office of Prescription Drug Promotion
Reference ID: 3173022
---------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------
----------------------------------------------------
This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
/s/
JAMES S DVORSKY 08/10/2012
ANDREW S HAFFER 08/10/2012
Reference ID: 3173022
Promotional Material
Posted: September 2012
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration Silver Spring, MD 20993
Josephine Secnik, MS, MBA Director, Global Regulatory Affairs– U.S. Eli Lilly and Company Lilly Corporate Center Indianapolis, Indiana 46285
RE: NDA #202008
Amyvid™ (Florbetapir F 18 Injection) for intravenous use
MA #9
Dear Ms. Secnik:
As part of its routine monitoring and surveillance program, the Office of Prescription Drug Promotion (OPDP), Division of Professional Drug Promotion (DPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a webpage (AM77988) for Amyvid™ (Florbetapir F 18 Injection) (Amyvid), submitted by Eli Lilly and Company’s (Eli Lilly) under cover of Form FDA-2253. This webpage includes a misleading multi-colored image of the brain. Additionally, OPDP has been made aware that these misleading images appeared in the commercial exhibit hall of the American Academy of Neurology annual meeting held in New Orleans, Louisiana on April 23-26, 2012. OPDP has determined that the materials misbrand Amyvid in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 352(a) & (n). See 21 CFR 202.1(e)(6)(xviii).
Background
Below are the indication and summary of the most serious and common risks associated with the use of Amyvid.1 According to the INDICATIONS AND USAGE section of the FDA-approved product labeling (PI):
Amyvid is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD) and other causes of cognitive decline. A negative Amyvid scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scanresult reduces the likelihood that a patient’s cognitive impairment is due to AD. A positive Amyvid scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Amyvid is an adjunct to other diagnostic evaluations.
1 This information is for background purposes only and does not necessarily represent the risk information that should be included in the promotional piece cited in this letter.
Limitations of Use:
• A positive Amyvid scan does not establish a diagnosis of AD or other cognitive
disorder.
• Safety and effectiveness of Amyvid have not been established for:
o Predicting development of dementia or other neurologiccondition;
o Monitoring responses to therapies.
The PI for Amyvid contains Warnings and Precautions regarding the risk of image
misinterpretation and other errors as well as the risk of radiation exposure. In addition,
according to the ADVERSE REACTIONS section of the PI, the most commonly reported
adverse reactions include headache, musculoskeletal pain, fatigue, and nausea.
Misleading Presentation
The Amyvid webpage features a multi-colored brain image. This presentation misleadingly
suggests that Amyvid PET images can be displayed, and therefore interpreted, in color in
patients with cognitive impairment who are being evaluated for Alzheimer’s Disease and
other causes of cognitive decline, when this is not the case. According to the DOSAGE AND
ADMINISTRATION section of the PI, Amyvid PET scans should be displayed and reviewed
“using a black-white scale with the maximum intensity of the scale set to the maximum
intensity of all the brain pixels.” The PI further includes several examples of black and white
scans to illustrate proper image interpretation.
While many PET images are displayed and reviewed in color, Amyvid scans, as described
above, must be displayed and reviewed using a black and white scale. Additionally, the PI
does not provide instructions for estimating β-amyloid neuritic plaque density using a color
scale with Amyvid. Therefore, use of the color PET scan image of a brain in Amyvid
promotional materials is misleading, particularly considering the warning regarding the risk for
image misinterpretation and other errors.
Conclusion and Requested Action
For the reasons discussed above, this webpage misbrands Amyvid in violation of the FD&C
Act, 21 U.S.C. 352(a) & (n). See 21 CFR 202.1(e)(6)(xviii).
(b) (4)
Please direct your response to the undersigned at the Food and Drug Administration,
Center for Drug Evaluation and Research, Office of Prescription Drug Promotion,
Division of Professional Drug Promotion, 5901-B Ammendale Road, Beltsville,
Reference ID: 3173022
Josephine Secnik Page 3 Eli Lilly and Company NDA 202008/MA #9
Maryland 20705-1266 or by facsimile at (301) 847-8444. Please note that the Division of Drug Marketing, Advertising, and Communications (DDMAC) has been reorganized and elevated to the Office of Prescription Drug Promotion (OPDP). OPDP consists of the Immediate Office, the Division of Professional Drug Promotion (DPDP) and the Division of Consumer Drug Promotion (DCDP). To ensure timely delivery of your submissions, please use the full address above and include a prominent directional notation (e.g. a sticker) to indicate that the submission is intended for OPDP. In addition, OPDP recently migrated to a different tracking system. Therefore, OPDP letters will now refer to MA numbers instead of MACMIS numbers. Please refer to MA # 9 in addition to the NDA number in all future correspondence relating to this particular matter. OPDP reminds you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Amyvid comply with each applicable requirement of the FD&C Act and FDA implementing regulations.
Sincerely,
{See appended electronic signature page}
James S. Dvorsky, PharmD Regulatory Review Officer Division of Professional Drug Promotion Office of Prescription Drug Promotion
{See appended electronic signature page}
Andrew S.T. Haffer, PharmD Acting Director Division of Professional Drug Promotion Office of Prescription Drug Promotion
Reference ID: 3173022
---------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------
----------------------------------------------------
This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.
/s/
JAMES S DVORSKY 08/10/2012
ANDREW S HAFFER 08/10/2012
Reference ID: 3173022
Promotional Material
Posted: September 2012
Basic Veterinary Compounding Course Offered By
The overall goal of this practice based course is to introduce the pharmacist and pharmacy technician to veterinary pharmacy compounding. This program provides the fundamental techniques for compounding medications for animals, as well as establishing and marketing a veterinary pharmacy practice.
Upon completion of this program, the participant will be able to:
- Demonstrate knowledge of regulatory requirements and professional standards that affect veterinary compounding
- Demonstrate the ability to perform calculations necessary to compound veterinary preparations
- Demonstrate the ability to compound a variety of veterinary preparations
- Demonstrate knowledge of animal diseases where a compounding pharmacist and/or technician can impact animal medication compliance.
When
Thursday September 27, 2012 at 8:00 AM CDT-to-
Friday September 28, 2012 at 5:00 PM CDT
Where
ACA National Training Laboratory2830 Summer Oaks Drive
Bartlett, TN 38134
For more information click here.
Friday, September 7, 2012
Strategic Agreement Launches Novel Drug Development Model
Professional Compounding Centers of America (PCCA) Invests $4 Million In San Diego-based Imprimis Pharmaceuticals; Agrees to Share Topical Drug-Delivery Knowledge and Technology to Bring New Medicines to Market
SOLANA BEACH, Calif., Sept. 7, 2012 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (IMMY: OTCQB) today announced a strategic development and investment agreement with Houston-based Professional Compounding Centers of America, Inc. (PCCA). The agreement will allow the companies to develop and share drug-formulation technology, with the goal of creating a new generation of treatments for muscle and joint pain, neuropathic pain and other conditions. PCCA also made a $4 million equity investment in Imprimis in a private transaction.
The agreement will give Imprimis exclusive non-PCCA-member access to PCCA's topical technologies and formulation know-how for delivering drugs directly through the skin. The arrangement is intended to identify development opportunities for new topical medications for new therapeutic applications.
Imprimis' lead drug candidate, Impracor™, a topical non-steroidal anti-inflammatory cream, is expected to enter Phase 3 clinical trials early in 2013. When approved for sale, Impracor would be applied to the site of muscle or joint pain, delivering a clinical dose of medication to the affected area without potential side effects such as stomach irritation or liver problems that have been associated with ingestible, non-steroidal, anti-inflammatory drugs.
The company has also developed Accudel™, a patented topical-delivery platform that can serve as a delivery vehicle for other medications.
To read the remainder of the article, click here.
Thursday, September 6, 2012
Dangers aside, drugmakers can't live without Chinese APIs
September 3, 2012 | By Eric Palmer
Read more: Dangers aside, drugmakers can't live without Chinese APIs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/dangers-aside-drugmakers-cant-live-without-chinese-apis/2012-09-03#ixzz25iHugod3
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When it comes Chinese-made APIs, Western drugmakers are between a rock and a hard place. They know Chinese oversight of bulk APIs is insufficient to snuff out substandard producers, but since China produces more APIs than any other country, they can't live without them.
"If China for some reason decided to stop exporting APIs, within three months all our pharmacies would be empty," Guy Villax, CEO of Hovione, tells Reuters. The Portuguese API supplier has factories in China, as well as the U.S. and Ireland.
After 80 U.S. patient deaths were tied to tainted Chinese heparin in 2008, Chinese authorities pledged to crack down on API suppliers. But a Reuters investigation finds that while China is doing more, the fact that many Chinese APIs are substandard or counterfeit is an open secret. "Illegal ingredients in bulk are a big problem, but nobody talks about it," Villax says.
Read more: Dangers aside, drugmakers can't live without Chinese APIs - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/dangers-aside-drugmakers-cant-live-without-chinese-apis/2012-09-03#ixzz25iHugod3
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