HB 412 IMPLEMENTATION FAQ
(Veterinary Pharmacies)
During the recent 2011 legislative session, the 96th Missouri General Assembly enacted House Bill 412 which requires a Missouri pharmacy permit for facilities or entities dispensing legend drugs for animal use by prescription/veterinarian order. This FAQ provides general information on complying with the new law which becomes effective on August 28, 2011. The Board’s goal is to educate the public regarding the new requirements and to assist in compliance.
FAQ
1)
Who needs a pharmacy license?
Effective August 28, 2011, any facility or entity selling or dispensing legend drugs for animal use by prescription/order must have a Missouri pharmacy permit. The new law does not apply to drugs that can be dispensed without a prescription/veterinarian order.
2)
Does HB 412 apply to all animal drugs?
No. The new law only applies to drugs that require a prescription/veterinarian order for animal use. Many veterinary antibiotics and vaccines can be dispensed over-the-counter without a prescription/order. The new law does not apply to over-the-counter products. Review the product label or check with your local veterinarian to determine if a prescription/veterinarian order is required for products in your inventory.
3)
What is a “legend drug”?
A “legend drug” is specifically defined in 21 USC §353 of federal law. As a general guide, the term applies to any drug that includes, or is required to include, one of the following cautionary statements on the label:
“Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian”
“Rx only”
“Caution: Federal law prohibits dispensing without a prescription”
Generally, products labeled “For Veterinary Use Only” do not require a prescription/veterinarian order. A pharmacy permit is not required to dispense or sell these products although other law/restrictions may apply.
4)
Does HB 412 apply to over-the-counter drugs?
No. HB 412 does not apply to over-the-counter products that can be sold without a prescription/order.
5)
What about antibiotics/vaccines?
Under federal law, many antibiotics and vaccines may be dispensed to animals without a prescription/order. HB 412 does not apply to antibiotics or vaccines that can be lawfully sold without a prescription/order. Review the product label or check with your local veterinarian to determine if a prescription/order is required.
6)
What about medicated animal feed?
Medicated animal feed does not fall under the definition of a legend drug. HB 412 does not apply to medicated animal feed.
7) What about animal devices?
HB 412 only requires a permit if you are providing legend drugs by prescription/order. The law does not
apply to the sale of devices.
8) How does the new law affect drugs dispensed by a veterinarian?
HB 412 does not restrict or apply to drugs dispensed by a veterinarian to his/her patients.
9) What type of pharmacy permit do I need?
Facilities may apply for a Class A (Community Ambulatory) pharmacy permit or a Class L (Veterinary
Pharmacy) permit. Class A pharmacies must have a Missouri licensed pharmacist present on site when
legend drugs are dispensed, sold or filled. Class L pharmacies will be authorized to operate and dispense
non-controlled drugs in the absence of a pharmacist as allowed by HB 412 and the Board’s rules.
However, Class L pharmacies may dispense legend drugs for animal use only and cannot dispense drugs for
human use.
10) If I have a Class A permit, do I need to add a Class L?
No. Class A pharmacies can dispense legend drugs for animal use under their current permit.
11) What are the requirements for a pharmacy permit?
To be licensed as a pharmacy, applicants must generally meet the following requirements:
The pharmacy’s equipment and facilities must be operated and maintained in a manner that will
not endanger the public health or safety;
The pharmacy must be equipped with proper reference materials and pharmaceutical and sanitary
appliances;
The pharmacy must be under the supervision of a registered pharmacist (designated as the
pharmacist-in-charge);
The pharmacy must be clean, sanitary and orderly. For Class L (Veterinary) permit applicants,
areas where legend drugs are stored or maintained must be clean and sanitary, and;
The pharmacy must be operated in compliance with all applicable laws, including, all pharmacy
and drug distribution laws and regulations.
For additional permit information/requirements, see the following statutes/rules: § 338.220, § 338.140, §
338.250, 20 CSR 2220-2.010 and 20 CSR 2220-2.020.
12) How do I apply for a pharmacy permit?
Pharmacy permit applications are available online at http://pr.mo.gov/pharmacists-forms.asp. Permit
applications may be filed now. The application fee is $ 300.
13) What about pharmacies located outside of Missouri?
Pursuant to 20 CSR 2220-2.025, non-resident pharmacies shall not ship, mail or deliver prescription drugs
into Missouri without first obtaining a Missouri pharmacy permit. This includes prescription drugs for
animal use. Non-resident permit applications/forms are available online at
http://pr.mo.gov/boards/pharmacy/375-0492.pdf.
14) Does a pharmacist have to be on site?
Class A Pharmacies: Under 20 CSR 2220-2.010(1)(B), Class A pharmacies must have a licensed
pharmacist present on site when any legend drug is compounded, dispensed or sold. Additionally
pharmacy technicians must be under the direct supervision of a Missouri licensed pharmacist.
Class L Pharmacies: Under HB 412, Class L pharmacies are not required to have a pharmacist on site if
a Missouri licensed pharmacist reviews the pharmacy’s activities and records, as authorized by HB 412
and the Board’s rules. As a result of the new law, pharmacy technicians in a Class L pharmacy may
only dispense or sell non-controlled medications without a pharmacist present if a Missouri licensed pharmacist performs the review required by the Board’s rules. At this time, the Board is in the process of promulgating rules. Note: A Missouri licensed pharmacist must be present on site of a Class L pharmacy whenever legend drugs are compounded for animal use or if the pharmacy sells or dispenses controlled substances.
15)
Will my staff need to be licensed/registered?
A Missouri pharmacy technician registration is required for any person who “assists in the practice of pharmacy.” Generally, technician registration will be required for:
Any person who routinely has independent access to prescription only drug products;
Any person who assists the pharmacist in the practice of pharmacy. This may include, but is not limited to, staff or personnel that may take prescription orders over the phone, and;
Any person that sells or dispenses prescription legend drugs.
For more on Missouri’s pharmacy technician requirements, see § 338.013 and 20 CSR 2220-2.700. For technician application requirements/forms, visit the Board’s website at http://pr.mo.gov/pharmacists-forms.asp.
16)
When will the Board promulgate rules for Class L pharmacies?
The Board is in the process of promulgating rules to implement HB 412. The Board anticipates filing the rules on or before September 1, 2011 (this date is tentative and subject to change). To receive future rule updates via e-mail, register for the Board’s e-alerts at http://pr.mo.gov/pharmacists-newsletter.asp. Rule updates will also be posted on the Board’s website.
17)
Who should I contact with questions?
You may e-mail the Board at pharmacy@pr.mo.gov or you may contact the Board office at (573) 526-6985. You may also contact the Board’s pharmacy inspector for your area. Inspector contact information is located on the Board’s website at http://pr.mo.gov/boards/pharmacy/territoryassignment.pdf.
Interested parties should review HB 412 as well as Chapter 338, RSMo, and the Board’s rules in their entirety to ensure compliance with Missouri law. The Board’s rules/statues are available online at http://pr.mo.gov/pharmacists.asp. The full text of HB 412 is available at http://www.house.mo.gov/billtracking/bills111/billpdf/truly/HB0412T.PDF
No comments:
Post a Comment