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
Saturday, June 23, 2012
Guidance Regarding Importation of API into the United States
A 2008 FDA seminar provided the following information regarding importation of API into the United States:
Pharmacy Compounding
a. Labeling (Must):
• “For Prescription Compounding”
• “Rx only”
b. Useful Information:
• API is a component of an FDA approved drug
• API meets official compendial requirements when applicable
Example: Certificate of Analysis
• Drug has not been withdrawn or removed from the U.S. market for public
health reasons (list in CPG 460.200)
• API product name and NDC #
• Name of API manufacturer and registration number
• A written commitment that the API will be sold and used solely for
pharmacy compounding by a state licensed pharmacy or federal facility
• A written commitment that the drug has not been withdrawn or removed
from the U.S. market for public health reasons
The remainder of the seminar outline can be found here.
HIPPA and Compounding Pharmacies
HIPPA requirements apply also to compounding pharmacies. To read an article regarding how HIPAA is being enforced, click the following: With Regulatory Enforcement of HIPAA on the Rise and Increased Penalties for Non-Compliance, Pharmacies Must Take Action.
Texas Pharmacy Association Conference
The Society of Veterinary Hospital Pharmacists Position on Compounding Drugs for Use in Animals
Below is the position of the Society of Veterinary Hospital Pharmacists with regarding to compounding drugs for use in animals.
The Society of Veterinary Hospital Pharmacists
Position Statement on Compounding of Drugs for Use in Animals
Purpose: The Society of Veterinary Hospital Pharmacists (SVHP) is an international professional organization of veterinary hospital pharmacists. Recognizing that compounding is essential to providing high quality pharmaceutical care for some animal
patients, SVHP, in keeping with our educational mission, seeks to identify concerns and offer guidance in compounding for veterinary patients. Therefore, SVHP endorses the following position statement on compounding for animals.
SVHP POSITION STATEMENT ON COMPOUNDING OF DRUGS FOR USE IN ANIMALS
1. Prescriptions for all compounded preparations shall be initiated by a veterinarian based on an individual patient’s need within the context of a valid veterinarian-client-patient relationship. Compounded medication may be dispensed to veterinarians for office use where applicable state/provincial law permits. Items compounded for office use may only be administered in the veterinarian’s office and not dispensed for use outside of the veterinarian’s office.
2. Compounding for veterinary patients shall comply with regulations promulgated by state/provincial boards of pharmacy, federal regulations, and legislative statutes.
3. SVHP supports food chain safety and discourages compounding for food animals. Food safety concerns preclude the use of compounded preparations unless information exists to assure avoidance of illegal residues in food. The extralabel use of specific drugs is banned in food-producing animals. Food animals are defined by “intended use” rather than species.
The Society of Veterinary Hospital Pharmacists
Position Statement on Compounding of Drugs for Use in Animals
Purpose: The Society of Veterinary Hospital Pharmacists (SVHP) is an international professional organization of veterinary hospital pharmacists. Recognizing that compounding is essential to providing high quality pharmaceutical care for some animal
patients, SVHP, in keeping with our educational mission, seeks to identify concerns and offer guidance in compounding for veterinary patients. Therefore, SVHP endorses the following position statement on compounding for animals.
SVHP POSITION STATEMENT ON COMPOUNDING OF DRUGS FOR USE IN ANIMALS
1. Prescriptions for all compounded preparations shall be initiated by a veterinarian based on an individual patient’s need within the context of a valid veterinarian-client-patient relationship. Compounded medication may be dispensed to veterinarians for office use where applicable state/provincial law permits. Items compounded for office use may only be administered in the veterinarian’s office and not dispensed for use outside of the veterinarian’s office.
2. Compounding for veterinary patients shall comply with regulations promulgated by state/provincial boards of pharmacy, federal regulations, and legislative statutes.
3. SVHP supports food chain safety and discourages compounding for food animals. Food safety concerns preclude the use of compounded preparations unless information exists to assure avoidance of illegal residues in food. The extralabel use of specific drugs is banned in food-producing animals. Food animals are defined by “intended use” rather than species.
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