PTCE: Federal Requirements

- Knowledge Area 2.1: Federal requirements for handling and disposal of non-hazardous, hazardous, and pharmaceutical substances and waste
- Knowledge Area 2.2: Federal requirements for controlled substance prescriptions (i.e., new, refill, transfer) and DEA controlled substance schedules
- Knowledge Area 2.3: Federal requirements (e.g., DEA, FDA) for controlled substances (i.e., receiving, storing, ordering, labeling, dispensing, reverse distribution, take-back programs, and loss or theft of)
- Knowledge Area 2.4: Federal requirements for restricted drug programs and related medication processing (e.g., pseudoephedrine, Risk Evaluation and Mitigation Strategies [REMS])
- Knowledge Area 2.5: FDA recall requirements (e.g., medications, devices, supplies, supplements, classifications)

Skills You Need To Know:
- Identify federal laws and regulations that affect pharmacy practice.
- Describe labeling requirements for both prescription and over-the-counter substances.
- Explain procedures that relate to the ordering, receiving, and documentation of non-controlled medications.
- Be familiar with federal guidelines for restricted drug programs and related medication processing.
- Describe restrictions placed on the sales of products containing pseudoephedrine.
- Understand federal guidelines that govern controlled prescriptions, including refill restrictions, prescription filling, DEA numbers, and transfers.
- Understand federal guidelines that surround the receipt, storage, ordering, disposal, removal, and transfer of controlled prescriptions.

Pharmacy Law
The PTCE follows federal guidelines and regulations. Federal laws take precedence unless the state law is stricter, in which case the state law governs. Pharmacy technicians should check with their State Board of Pharmacy for additional laws that may apply.
Federal laws and regulations have impacted pharmacy practice by protecting patients’ well-being and maintaining efforts to ensure the safety and health of all patients. Many of these laws originated from crisis events, which brought attention to the issues of safety and security. These crisis events led to the creation of legislation that would not only provide these safety measures but would also shape reform in pharmacy practice.

Pure Food and Drug Act of 1906
- This act prohibited interstate commerce of misbranded and adulterated drugs, foods, and drinks.
- The focus was on purity, not safety.
- This act did not protect false therapeutic claims.
- Legislation did not require manufacturer labels to list active ingredients, directions for use or warnings, and safety concerns.

Federal Food, Drug, and Cosmetic Act (FFDCA) of 1938
- This act was produced in response to shortfalls of the Pure Food and Drug Act of 1906.
- Enactment of this legislation was hastened in 1937 due to the deaths of over 100 individuals who had consumed a sulfa-based elixir that contained diethylene glycol, a chemical similar to ethylene glycol used in antifreeze.
- This act required drug labeling to include directions for use, warnings, and safety concerns.
- It provided mandates for premarketing approval of all drugs.
- This act ensured that the FDA oversees all provisions and classifies offenses as either misbranded or adulterated. A product may be labeled misbranded if it meets any of the following criteria:

1.The product is misrepresented, which is often seen in labeling (e.g., the omission of important information on the label).
2.The product does not comply with color additive provisions as established by the FFDCA.
3.The product is dangerous when used “in the dosage or manner or with the frequency or duration prescribed, recommended, or suggested in the labeling” as per the U.S. Food and Drug Administration, 2017.
4.The label fails to include the “name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count” as per the U.S. Food and Drug Administration, 2017.
5.“Any required wording is not prominently displayed as compared with other wording on the device or is not clearly stated” as per the U.S. Food and Drug Administration, 2017.

A product may be labeled adulterated if the drug “fails to conform to compendial standards of quality, strength, or purity” as per the U.S. Food and Drug Administration, 1992.

The tables below list the current drug labeling requirements for prescription and over-the-counter (OTC) drugs, respectively. Figure 5-1 shows an example of an over-the-counter label.

Prescription Drug Labeling Requirements
- Highlights
- Limitations statement
- Product name and initial FDA approval date
- Boxed warning
- Recent major changes
- Indications and usage
- Dosage and administration
- Dosage form and strength
- Contraindications
- Warnings and precautions
- Adverse reactions
- Drug interactions
- Use in specialized populations
- Patient counseling information
As per the U.S. Food and Drug Administration, 2021




Over-the-counter (OTC) label example

OTC Drug Labeling Requirements
- Active drug
- Uses
- Warnings
- Inactive ingredients
- Purpose
- Directions
- Other information, such as storage requirements
- Expiration date
- Batch or NDC number
- Name and address of the manufacturer, packer, or distributor
- Quantity of the product in the package
- Instructions in case of an overdose
As per the U.S. Food and Drug Administration, 2015

The Comprehensive Drug Abuse Prevention and Control Act of 1970
- It is more commonly known as the Controlled Substances Act.
- This law requires registration, recordkeeping, and rules regarding dispensing of controlled drugs.
- Substances are placed into one of five categories called schedules.

Table: Controlled Substances Schedules

Registration
New pharmacies must first obtain a state license. Facilities that dispense controlled substances register with the DEA by using a DEA 224 form. The form can be obtained online or a written form can be requested by contacting the DEA. The certificate of registration should be maintained at the registered location and kept in an accessible place for inspections. Registration is valid for 3 years and can be renewed using a DEA 224a form available online. This form can be completed 60 days prior to the expiration date. In the event that the pharmacy needed a duplicate Certificate of Registration form (DEA 223 form), the pharmacy can request a copy online, via phone, or via email.

Ordering, Receiving, and Documenting Requirements
Pharmacies must maintain complete and accurate inventories for all controlled substances, including those purchased, received, dispensed, or otherwise disposed of.
- Schedule II medications may be ordered using a paper DEA 222 form, which is a triplicate form that must be handwritten or typed and then signed by the individual who is registered with the DEA. The DEA has also developed the Controlled Substance Ordering System (CSOS), which allows individuals who are registered with the DEA to electronically order controlled substances without using a paper DEA 222 form.

- A maximum of ten items may be ordered per form. The number of items should match the quantity marked on the bottom of the form. Copy 1 (top copy) is retained by the supplier. Copy 2 (middle copy) is forwarded to the DEA. Copy 3 (bottom copy) is received by the purchaser.
- The DEA 222 form is valid for only 60 days.
- The DEA 222 form should contain the pharmacy’s name and DEA number and must be signed by the person who receives and verifies the inventory.

Upon receipt, the purchaser must record the number of items received and the date that they were received. All DEA 222 forms, including those that are incomplete or illegible, should not be thrown away. Instead, they must be maintained in the pharmacy for a minimum of 2 years.
- Schedule II prescriptions should be maintained for a period of 2 years and are filed separately from Schedule III, IV, and V prescriptions.
- Schedule III, IV, and V prescriptions should be maintained for a period of 2 years.
- Schedule III, IV, and V prescriptions may be ordered online, over the phone, or via fax. All invoices should be maintained by the pharmacy, signed, dated, and stamped with a red “C.” Invoices must be maintained for a minimum of 2 years.
Prescriptions containing controlled substances, and stock bottles containing controlled substances, may also have a red “C” stamp to visually note the presence of a controlled medication.

Inventory and Storage Requirements
All controlled substances should be inventoried upon the very first day that the pharmacy opens (the first day of business). Federal law requires a biennial inventory of controlled substances. The inventory record must be kept in a retrievable location and maintained for 2 years.
In regard to storage, federal requirements dictate that all controlled substances must be stored in a securely locked cabinet or dispersed on pharmacy shelves with non-controlled medications. However, many pharmacies will keep C-IIs in a locked cabinet. C-III, IV, and V medications may be placed on pharmacy shelves with other non-controlled medications, but federal law does state that the area must be secure. For this reason, pharmacy doors are locked and only approved personnel are allowed into the pharmacy.
- Inventory counts of Schedule II drugs should be kept separate in a separate file from inventory counts of Schedule III, IV, and V drugs.
- Schedule II drugs must be physically counted; Schedule III, IV, and V drugs can be estimated, unless the bottle contains more than 1,000 tablets or capsules, in which case a physical count is required.

Prescription Restrictions
Schedule II prescriptions may be either written or computer generated, but they must be presented in person at the pharmacy. The prescription is to be signed in ink or should contain a digital signature by the prescribing authority. It must also contain a valid DEA number. Institutions are granted an institutional DEA number. Prescribers from that hospital are given an identifier number to be used with the institutional DEA number. DEA numbers are required on all controlled prescriptions.
- DEA numbers consist of two letters and seven numbers.
- The first letter of the DEA number identifies the type of registrant.

○ A/B/F/G: Hospital, clinic, practitioner, teaching institution, pharmacy
○ M: Mid-level practitioner
○ P/R: Manufacturer, distributor, researcher, importer, exporter, reverse distributor, narcotic treatment program
○ G: Department of Defense (DoD) personal services contractor
○ X: Suboxone/Subutex prescribing program

- The second letter is the first letter of the prescribing individual’s last name.

Schedule III or IV prescriptions may be handwritten or computer-generated, but they must be signed by the prescriber in ink or must contain a digital signature. They may also be sent electronically. Depending upon state law, they may also be faxed or phoned into the pharmacy.
The use of DEA numbers on non-controlled prescriptions is strongly opposed by the DEA. In 2007, all covered health care providers were required to obtain a unique ten-digit identifier, known as a National Provider Identifier or NPI. Covered health care providers and health plans must use the NPI on all administrative and financial transactions, as mandated by HIPAA. NPI numbers are used to process pharmacy claims and are often found on the prescription or prescriber profile.

Refill Restrictions
Prescriptions for Schedule II drugs may not be refilled. Schedule III and IV drugs may be refilled up to five times within 6 months after the date of issue. Partial fills for Schedule III and IV drugs are irrelevant as long as the total quantity dispensed meets the total quantity prescribed within the 6 month time frame. Each partial fill is recorded in the same manner as a refill. Partial fills (emergency fills) for Schedule II drugs may be dispensed if the pharmacist cannot supply the full quantity for a written or an emergency oral prescription. The pharmacist must note the quantity supplied on the front of the prescription. The remaining quantity must be supplied within 72 hours of the partial dispensing date. A new prescription must be presented for the remaining quantity to be dispensed. The prescribing physician should be notified of any prescriptions not picked up within 72 hours. Prescriptions for Schedule V and non-controlled prescriptions may be refilled as authorized by the prescriber.

Transfer Restrictions
The original prescription for Schedule III, IV, and V drugs may be transferred one time between pharmacies. Pharmacies that share an online database may transfer a Schedule III, IV, or V prescription up to the maximum number of refills as stated on the original prescription.
- All transferred prescriptions must be communicated between pharmacists.
- The transferring pharmacist must write “void” on the front of the prescription and include the name, address, and DEA number of the receiving pharmacy on the back.
- The receiving pharmacist’s name should also be noted on the back of the prescription.
- The receiving pharmacist should write “transfer” on the front of the prescription and record the following:

○ The original date of issuance for the prescription
○ The number of refills
○ The original dispensing date
○ The number of refills remaining
○ The name, address, and DEA number of the transferring pharmacy
○ The name of the pharmacist who is receiving the transferred prescription
○ The name, address, and DEA number of the pharmacy where the prescription was originally filled (including the original prescription number)

- Both the original and transferred prescription should be filed and maintained for a period of 2 years.

Return, Destruction, and Theft Regulations
Controlled substances may be returned between DEA registrants using a DEA 222 form. Outdated or damaged controlled substances may be destroyed using a DEA 41 form. The registrant who is destroying the medication must provide the following:
- The registrant’s DEA registration number, name, and address on the DEA registration, as well as a valid telephone number
- An inventory of the controlled substances that are to be destroyed, including NDC numbers, names, strengths, forms, and quantities
- The date, location, and method of destruction
- The signatures of two witnesses who are authorized employees

The pharmacy can also choose to transfer controlled substances to a DEA-registered reverse distributor who handles the disposal of controlled substances. In the case of a transfer to a reverse distributor, the reverse distributor must issue a DEA 222 form or an electronic equivalent to the pharmacy. If Schedule III- V medications are submitted to a reverse distributor for disposal, the pharmacy must maintain a record of distribution, listing the name, strength, dosage form, quantity, and date of the transfer. The reverse distributor will then complete and submit a DEA 41 form to the DEA.
Upon theft of a medication, the pharmacy must notify both the nearest DEA diversion office and the local police department and then fill out a DEA 106 form. The original form is sent to the DEA, and a copy of the form is retained by the pharmacy.

Take Back Events and Unused Prescription Disposal
The DEA periodically hosts national prescription take back events in communities where temporary collection sites are set up for the safe disposal of prescription drugs. Additionally, permanent collection sites are also available to DEA-registered collectors. These collection sites are often found in retail pharmacies, hospitals, and law enforcement facilities. These sites may offer mail-back programs or collection receptacles to assist in the collection of unused medications.
Consumers can also read the patient package insert for specific disposal instructions. If disposal instructions are not available, and a collection site is also not available, the following steps are recommended:

- Mix unused medication with an inedible substance, such as coffee grounds, dirt, or cat litter.
- Place the mixture in a sealed container.
- Throw the container in the household trash.
- Delete all personal information on the prescription vial label, and dispose of the container.

The FDA has identified a series of medications that are considered to be potentially dangerous and recommends that they be immediately flushed down the toilet when a take back option is not available. These medications include buprenorphine, diazepam, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, methylphenidate, morphine, oxycodone, and sodium oxybate.

Poison Prevention Packaging Act (PPPA) of 1970
This act was passed in response to a growing number of accidental poisonings involving children. The Poison Prevention Packaging Act approved the U.S. Consumer Product Safety Commission’s (CPSC) authority to identify household products and drugs that require child-resistant containers.
Tests were performed, and a childproof container was deemed to be acceptable if no more than 20% of children could open the container. Exceptions for childproof containers were determined for certain products.

Table: Childproof Container Exemptions
- OTC products available in a single-sized package with the label “This Package for Households Without Young Children” or “Package Not Child-Resistant”
- Powdered, unflavored aspirin and effervescent aspirin
- Sublingual nitroglycerin
- Inhalation aerosols
- Hormone replacement therapy
- Oral contraceptives in the original manufacturer’s dispensing package
- Isosorbide dinitrate in dosage strengths of 10 milligrams or less
- Erythromycin ethylsuccinate containing no more than 8 grams or the equivalent of erythromycin
- Erythromycin ethylsuccinate tablets in packages containing no more than the equivalent of 16 grams of erythromycin
- Anhydrous cholestyramine in powder form
- Potassium supplements in unit dose forms, including individually wrapped effervescent tablets, unit dose vials of liquid potassium, and powdered potassium in unit dose packets, containing no more than 50 milliequivalents per unit dose
- Sodium fluoride drug preparations, including liquid and tablet forms, containing no more than 264 milligrams of sodium fluoride per package
- Betamethasone tablets packaged in the manufacturers’ dispenser packages containing no more than 12.6 milligrams of betamethasone
- Mebendazole in tablet form in packages containing no more than 600 milligrams of the drug
- Methylprednisolone in tablet form in packages containing no more than 84 milligrams of the drug
- Colestipol in powder form in packages containing no more than 5 grams of the drug
- Pancrelipase preparations in tablet, capsule, or powder form
- Prednisone in tablet form when dispensed in packages containing no more than 105 milligrams of the drug

As per the U.S. Consumer Product Safety Commission, 2005
Restricted Drug Programs and Provisions
Some medications have special requirements, as mandated by the FDA, to improve patient safety and/or compliance. These requirements limit the way medications are dispensed, prescribed, or purchased. In 2007, the FDA established the Food and Drug Administration Amendments Act (FDAAA), which placed special requirements on identified medications.
The FDA also approved a special restricted distribution program called the Risk Evaluation and Mitigation Strategies (REMS) program. A REMS program encourages safe and effective medication use. Medications are selected based on adverse effects, teratogenicity, abuse potential, and the necessity for appropriate dosing to minimize patient risk. The FDA may require manufacturers to submit a REMS program upon drug approval. Selected medications that require a REMS program include buprenorphine, clozapine, fentanyl, hydromorphone, isotretinoin, naltrexone ER, oxycodone, pseudoephedrine, thalidomide, and vigabatrin. Nicotine-containing products and opioids also have REMS initiatives in place. Medications may also be part of a limited distribution program, which generally provides access to specialty medications, insurance assistance, and patient counseling services. REMS programs vary and may include the use of medication guides, communication plans, elements to assure safe use (ETASU), an implementation system, and a timetable for submission of assessments.

Pseudoephedrine-Containing Products
Ephedrine, pseudoephedrine, and phenylpropanolamine are described as “scheduled listed chemical products” under the Controlled Substances Act. This act places restrictions on products that contain ephedrine, pseudoephedrine, and phenylpropanolamine.
- SALES RESTRICTIONS: An individual may not purchase more than 3.6 g/day and 9 g/month (a 30-day period) of base product from a retail pharmacy or more than 7.5 g/month of base product from a mail-order pharmacy.
- STORAGE REQUIREMENTS: Products must be maintained behind the pharmacy.
- RECORDKEEPING REQUIREMENTS: A written or an electronic logbook must be maintained with information pertaining to the product name, quantities sold, patient identifying information (name and address of the purchaser), date, and time of the sale.

Isotretinoin (Absorica, Amnesteem, Claravis, Myorisan, Sotret)
Isotretinoin is used to treat severe nodular acne and belongs to a class of drugs known as retinoids. Isotretinoin is not used as first-line therapy for the treatment of acne; conventional treatment, including systemic antibiotic therapy, should be initiated first. Isotretinoin is teratogenic and is associated with other potentially serious side effects, including psychiatric disorders. For these reasons, and to minimize fetal exposure, isotretinoin may only be prescribed using a REMS program known as iPLEDGE.
The goals of the iPLEDGE program are to prevent fetal exposure to isotretinoin and to inform prescribers, pharmacists, and patients about the serious risks and safe use conditions for isotretinoin. This program is a computer-based, risk management system that links all members of the health care team (the prescriber, the pharmacy, the patient, and the wholesaler). The key points to remember about the iPLEDGE program are:
- REGISTRATION: The prescriber, the pharmacy, the patient, and the wholesaler must be included in the iPLEDGE registry. Patients must complete a consent form that outlines the potential consequences of taking the drug, obtain counseling about the potential risks and requirements for safe use, and comply with all required pregnancy testing.
- PRESCRIPTIONS: All prescriptions must be written for 30-day allotments. Prescriptions cannot be faxed, sent electronically, or phoned in. There is a 7-day window, counting the date of a pregnancy test as day 1, to fill and pick up all prescriptions.
- TESTING AND SAFETY: Female patients of childbearing potential must have had two negative urine or serum pregnancy tests before they can receive the prescription. The patient must have also used two forms of birth control for at least 1 month prior to initiation of isotretinoin therapy, during isotretinoin therapy, and for 1 month after isotretinoin therapy.
- REPORTING: Mandatory quarterly reporting of all isotretinoin adverse side effects is required, including all deaths within 15 days of the incident.

Patient Package Inserts and Medication Guides
Manufacturers must provide patient package inserts and medication guides for drugs deemed to have serious and significant risks. These written guides and inserts must be given to patients. They inform patients about the risks and benefits of the prescription medications.

Patient package inserts, or PPIs, are written summaries of patient information about specific risks and benefits. PPIs are based on the FDA-approved package insert. This insert provides clinical information about the drug and is written in consumer-friendly terminology. The FDA mandates that certain classes of medications, such as estrogen-containing medications and oral contraceptives, include PPIs. In 2006, the FDA made a revision stating that all PPIs must also include a table of contents and a summary section that highlights the benefits and risks.
Medication guides are another form of written patient information. Medication guides address issues specific to particular drugs and drug classes. They contain FDA-approved information that can help patients avoid serious adverse events.

Recalls
The Food and Drug Administration defines a drug recall as either an involuntary or a voluntary effort to remove a product from the market. The recall may be conducted by the drug manufacturer, by request of the FDA, or by a regulatory agency authorized by the FDA.
Recalls are classified by severity into three groups.

Table:Recall Classifications

The FDA may take other actions including an FDA market withdrawal or an FDA medical device safety alert. In an FDA market withdrawal, a withdrawal is issued for a product that has a minor violation that would not warrant legal action. For example, a product may be withdrawn due to tampering without proof of manufacturing or distribution problems. In contrast, an FDA medical device safety alert is when a recall is issued for a medical device that may present an unreasonable risk of substantial harm.

Handling and Disposal of Non-Hazardous, Hazardous, and Pharmaceutical Substances and Waste
Medications are made of chemical compounds that not only affect the patient when used or taken, but also can have effects on the people that handle them. Caution must be taken to avoid absorption of a liquid through the skin or inhalation of dust; hazardous compounds can burn
through the skin, and some medications cause teratogenic effects when taken. Personnel handling hazardous substances should use a minimum of two pairs of gloves. In the pharmacy, medication waste consists of medications that are unused, expired, or can no longer be used for the intended purpose. Medications that are returned to stock and medications that are sent to a reverse distributor are not included in this definition.

Non-Hazardous Substances
Non-hazardous waste, which includes the majority of pharmacy substances and medications, can be disposed of in designated bins, usually those that are blue or white, or in regular trash if it will be incinerated. The removal of this waste is typically handled by using a reverse distributor. IV fluids, such as lactated Ringer’s, dextrose, and saline, may be poured down the drain. However, this practice is widely dependent on state laws and hospital policies.

Hazardous Substances
Disposal of pharmaceutical waste must meet all state and federal guidelines according to the U.S. Environmental Protection Agency (EPA). Hazardous waste can either be categorized into one of four categories (P, U, K, or F)—as listed in the Resource Conservation and Recovery Act—or be categorized as meeting a hazardous waste characteristic. These characteristics include ignitability, corrosivity, reactivity, and toxicity. Pharmaceutical wastes can be found on both P and U lists, as well as on characteristic lists:
- EXAMPLES OF P-LIST WASTE: epinephrine, nicotine patches, nitroglycerin, phentermine, physostigmine, and warfarin >0.3%
- EXAMPLES OF U-LIST WASTE: chlorambucil, cyclophosphamide, lindane, mercury, reserpine, selenium sulfide, and warfarin < 0.3%
- EXAMPLES OF CHARACTERISTIC WASTE: erythromycin gel 2% (ignitable), lindane (toxic), paclitaxel injections (toxic), selenium sulfide (toxic), silver nitrate applicators (ignitable), and thiomersal-containing drugs (toxic)

Chemotherapy agents are not listed under the EPA category list of hazardous drugs but are typically disposed as such and placed in yellow bins.
Pharmacies that prepare hazardous drugs must have a negative pressure room to house engineering controls. These controls are to be used for hazardous preparations only and are separate from the controls used for non-hazardous preparations. Approved biological safety cabinets are used for the preparation of hazardous medications. The OSHA recommends using only vertical laminar flow hoods. Any items in a spill cleanup kit that come in contact with hazardous waste must also be considered hazardous and disposed of properly.
Safety data sheets (SDS), which are written by the manufacturer, provide information about hazardous chemicals, including the associated hazards, proper handling and cleanup procedures, and proper selection of personal protective equipment (PPE).
The SDS are maintained near the designated compounding area, or near designated hazardous chemicals, and should be consulted in case of accidental exposure. An initial incident report (IIR) may be used by the facility to document the exposure.

SDS information is classified into 16 universal categories.

Table: Safety Data Sheet Components
1. Identification
2. Hazard(s) Identification
3. Composition/Information on Ingredients
4. First-Aid Measures
5. Fire-Fighting Measures
6. Accidental Release Measures
7. Handling and Storage
8. Exposure Controls/Personal Protection
9. Physical and Chemical Properties
10. Stability and Reactivity
11. Toxicological Information
12. Ecological Information (non-mandatory)
13. Disposal Considerations (non-mandatory)
14. Transport Information (non-mandatory)
15. Regulatory Information (non-mandatory)
16. Other Information
As per the U.S. Department of Labor

Hospitals typically employ the use of an outside hazardous waste vendor to assist in managing waste generated in the pharmacy. The vendor must be licensed by the EPA to transport hazardous wastes. Hazardous wastes must be properly stored in black, or other designated, waste bins until the vendor arrives and picks the waste up for removal. If hazardous wastes are mixed, the most restrictive requirements must be followed for disposal. Hazardous waste vendors can also take controlled substances if the vendor is registered with the DEA. A DEA 222 form must be used to document the transfer of C-II substances, while a detailed inventory log is used to document the transfer of C-III- C-V substances.

Summary
- Restrictions on the use of medications vary. Pharmacy personnel should check their pharmacy policies and procedures, SDS, and REMS for information about the proper usage and distribution of these medications.
- Controlled medications are regulated by the DEA, and, as such, there are strict guidelines for controlled prescriptions.
- Controlled substance schedules are based on the substance’s abuse potential and legal status.
- The handling and disposal of pharmaceutical compounds is critical and may vary based on the classification of the substance.
- Pharmacy technicians should be aware of state regulations, pharmacy policies and procedures, EPA guidelines, and SDS provisions when handling hazardous chemicals.